Monday, March 22, 2010

USDA CONSUMER ALERT: Keeping Food Safe During An Emergency
http://www.fsis.usda.gov/News_&_Events/NR_031810_01/index.asp
WASHINGTON - March 18, 2010 -

Steps to follow to prepare for a possible weather emergency:

* Keep an appliance thermometer in the refrigerator and freezer. An appliance thermometer will indicate the temperature inside the refrigerator and freezer in case of a power outage and help determine the safety of the food.

* Make sure the freezer is at 0° F or below and the refrigerator is at 40° F or below.

* Freeze containers of water for ice to help keep food cold in the freezer, refrigerator or coolers after the power is out.

* Freeze refrigerated items such as leftovers, milk and fresh meat and poultry that you may not need immediately — this helps keep them at a safe temperature longer.

* Plan ahead and know where dry ice and block ice can be purchased.

* Have coolers on hand to keep refrigerator food cold if the power will be out for more than 4 hours. Purchase or make ice cubes and store in the freezer for use in the refrigerator or in a cooler. Freeze gel packs ahead of time for use in coolers.

* Group food together in the freezer — this helps the food stay cold longer.

* Store food on shelves that will be safely out of the way of contaminated water in case of flooding.


Steps to follow after the weather emergency:

* Keep the refrigerator and freezer doors closed as much as possible to maintain the cold temperature.

* The refrigerator will keep food safely cold for about 4 hours if it is unopened. A full freezer will hold the temperature for approximately 48 hours (24 hours if it is half full) and the door remains closed.

* Discard refrigerated perishable food such as meat, poultry, fish, soft cheeses, milk, eggs, leftovers and deli items after 4 hours without power.

* Food may be safely refrozen if it still contains ice crystals or is at 40° F or below when checked with a food thermometer.

* Never taste a food to determine its safety!

* Obtain dry or block ice to keep your refrigerator and freezer as cold as possible if the power is going to be out for a prolonged period of time. Fifty pounds of dry ice should hold an 18-cubic-foot full freezer for 2 days.

* If the power has been out for several days, check the temperature of the freezer with an appliance thermometer. If the appliance thermometer reads 40° F or below, the food is safe to refreeze.

* If a thermometer has not been kept in the freezer, check each package of food to determine its safety. If the food still contains ice crystals, the food is safe.

* Discard any food that is not in a waterproof container if there is any chance that it has come into contact with flood water. Discard wooden cutting boards, plastic utensils, baby bottle nipples and pacifiers.

* Thoroughly wash all metal pans, ceramic dishes and utensils that came in contact with flood water with hot soapy water and sanitize by boiling them in clean water or by immersing them for 15 minutes in a solution of 1 tablespoon of unscented, liquid chlorine bleach per gallon of drinking water.

* Undamaged, commercially prepared foods in all-metal cans and retort pouches (for example, flexible, shelf-stable juice or seafood pouches) can be saved. Follow the Steps to Salvage All-Metal Cans and Retort Pouches in the publication "Keeping Food Safe During an Emergency" at: www.fsis.usda.gov/Fact_Sheets/
Keeping_Food_Safe_During_an_Emergency/index.asp

* Use bottled water that has not been exposed to flood waters. If bottled water is not available, tap water can be boiled for safety. For more information on drinking water safely during weather emergencies, access the FSIS publication "Keeping Food Safe During an Emergency" at: www.fsis.usda.gov/Fact_Sheets/
Keeping_Food_Safe_During_an_Emergency/index.asp

* When in Doubt, Throw it Out!




Tips to Prevent Poisonings
http://www.cdc.gov/HomeandRecreationalSafety/Poisoning/preventiontips.htm

Safety Tips for You, Your Family, and Friends

Unless noted, the safety tips below were adapted from the American Association of Poison Control Centers’ poison prevention tips for children and adults.
Drugs and Medicines

* Follow directions on the label when you give or take medicines. Read all warning labels. Some medicines cannot be taken safely when you take other medicines or drink alcohol.
* Turn on a light when you give or take medicines at night so that you know you have the correct amount of the right medicine.
* Keep medicines in their original bottles or containers.
* Never share or sell your prescription drugs.
* Keep opioid pain medications, such as methadone, hydrocodone, and oxycodone, in a safe place that can only be reached by people who take or give them.
* Monitor the use of medicines prescribed for children and teenagers, such as medicines for attention deficit disorder, or ADD (SAMHSA 2006).
* Dispose of unused, unneeded, or expired prescription drugs. Follow the federal guidelines for how to do this (ONDCP 2009).External Web Site Icon

Household Chemicals and Carbon Monoxide

* Always read the label before using a product that may be poisonous.
* Keep chemical products in their original bottles or containers. Do not use food containers such as cups, bottles, or jars to store chemical products such as cleaning solutions or beauty products.
* Never mix household products together. For example, mixing bleach and ammonia can result in toxic gases.
* Wear protective clothing (gloves, long sleeves, long pants, socks, shoes) if you spray pesticides or other chemicals.
* Turn on the fan and open windows when using chemical products such as household cleaners.

Keep Young Children Safe from Poisoning

* Put the poison control number, on or near every home telephone and save it on your cell phone. The line is open 24 hours a day, 7 days a week.
* Keep all drugs in medicine cabinets or other childproof cabinets that young children cannot reach.
* Avoid taking medicine in front of children because they often copy adults.
* Do not call medicine “candy.”
* Be aware of any legal or illegal drugs that guests may bring into your home. Do not let guests leave drugs where children can find them, for example, in a pillbox, purse, backpack, or coat pocket.
* When you take medicines yourself, do not put your next dose on the counter or table where children can reach them.
* Never leave children alone with household products or drugs. If you are using chemical products or taking medicine and you have to do something else, such as answer the phone, take any young children with you.
* Do not leave household products out after using them. Return the products to a childproof cabinet as soon as you are done with them.
* Identify poisonous plants in your house and yard and place them out of reach of children or remove them.
* Read about how to prevent lead poisoning.

What to do if a poisoning occurs

1. Remain calm.
2. Call 911 if you have a poison emergency and the victim has collapsed or is not breathing. If the victim is awake and alert, dial 1-800-222-1222. Try to have this information ready:
* the victim’s age and weight
* the container or bottle of the poison if available
* the time of the poison exposure
* the address where the poisoning occurred
3. Stay on the phone and follow the instructions from the emergency operator or poison control center.

Poisoning Prevention in Your Community
Raise awareness about unintentional poisonings and to share prevention tips. You can find more information and event materials at the National Poison Prevention Week CouncilExternal Web Site Icon.


You can talk with local schools about teaching poison prevention. Lesson plans are available from the American Association of Poison Control CentersExternal Web Site Icon.

References

Office of National Drug Control Policy. Proper disposal of prescription drugs [online]. [cited 2009 December 2]. Available from URL: http://www.whitehousedrugpolicy.gov/publications/pdf/prescrip_disposal.pdfExternal Web Site Icon

Substance Abuse and Mental Health Services Administration. How do kids get prescription drugs? [online]. [cited 2006 October 26]. Available from URL: http://family.samhsa.gov/monitor/howpresdrug.aspxExternal Web Site Icon
Sources for Additional Information

American Association of Poison Control Centers, Inc.External Web Site Icon

CDC: Carbon Monoxide Poisoning: Prevention Guidelines

Substance Abuse and Mental Health Services AdministrationExternal Web Site Icon




Contact Us:

* Centers for Disease Control and Prevention
National Center for Injury Prevention and Control (NCIPC)
4770 Buford Hwy, NE
MS F-63
Atlanta, GA 30341-3717
* 800-CDC-INFO
(800-232-4636)
TTY: (888) 232-6348
24 Hours/Every Day
* cdcinfo@cdc.gov



* Page last updated: March 12, 2010
* Content source: Centers for Disease Control and Prevention
* National Center for Injury Prevention and Control


* Links to non-Federal organizations found at this site are provided solely as a service to our users. These links do not constitute an endorsement of these organizations or their programs by CDC or the Federal Government, and none should be inferred. CDC is not responsible for the content of the individual organization Web pages found at these links.
Poison Prevention Tips
http://www.aapcc.org/dnn/PoisoningPrevention/tabid/116/Default.aspx


STORE POISONS SAFELY

* Store medicines and household products locked up, where children cannot see or reach them.

* Store poisons in their original containers.

* Use child-resistant packaging. But remember — nothing is child-proof!

USE POISONS SAFELY

* Read the label. Follow the directions on medicines and products.

* Are children around? Take the product or medicine with you to answer the door or the phone.

* Lock products and medicines up after using them.

* Is it medicine? Call it medicine, not candy.

* Children learn by imitation. Take your medicines where children can’t watch.

TEACH CHILDREN TO ASK FIRST

* Poisons can look like food or drink. Teach children to ask an adult before eating or drinking anything!




Poison Tips for Children

http://www.aapcc.org/dnn/PoisoningPrevention/ChildTips/tabid/120/Default.aspx



* If you don't know what something is, never put it in your mouth. Always ask a trusted grown up first.
* Never take medicine unless a grown-up gives it to you.
* Some plants and berries are poisonous. Always ask a grown-up before you put them in your mouth.
* Always let grown-ups use spray cans and bottles. Do not touch or play with them!
* Stay away from things used to clean your house, clothes or car.

What is a poison?



How can you get poisoned?

You can get poisoned by eating, drinking, touching, or smelling something that can make you sick or hurt you. Some things, like medicine, can make you sick if you take the wrong kind, or if you take too much. Always ask a trusted grown-up before you take any medicine. Never put anything in your mouth if you are not sure if it is safe to eat. Ask a grown-up first!

Where are poisons found?

Poison can be found in any room in your home. They can even be found in Grandma’s purse! Poisons can be found outside, like some plants, berries and mushrooms.

What can you do if someone gets poisoned?

If you think you got into a poison, tell a grown-up right away! They will call the poison center. The poison center will tell them how to help you. If you think your Mom or Dad, or your brother or sister, or even your friend got into a poison, you can call the poison center too. Learn the poison center's phone number: and make sure you have the number of the poison center on or near the telephones in your house.



Poison Tips for Teens
http://www.aapcc.org/dnn/PoisoningPrevention/TeenTips/tabid/121/Default.aspx

Why do babysitters or teens need to know about poison?

Caring for children is a great job, but keeping children safe is a serious and important part of babysitting.

Poisoning is one of the most common childhood injuries.

Most of the time poisoning happens right at home. Children who are between the ages of eight months and six years old are the most likely to be poisoned.

Poisons can look like things that are good to eat and drink. They can come in many colors and forms including solids, liquids, sprays or gases. Young children are curious. They like to put things in their mouth, especially if they look colorful or smell nice. It's a good idea to have emergency information handy when you're babysitting.



What are some common poisons?

Poisonous products that may be found in and around the home:

* medicines



* iron pills

* cleaning products



* cleaning products

* laundry products



* nail glue remover and primer

* batteries



* bug and weed killers

* cigarettes



* alcohol

* mouthwash



* plants (indoor and outdoor)

* lighter fluids









How can children be kept safe from poison?

Follow these safety tips:

* Keep children where you can see them at all times, even when you go to answer the door or telephone. Never leave young children alone, not even for just a minute!



* All medicines and household cleaning products should be stored in locked cabinets, out of the reach and sight of children. Do not leave poisons on a counter or in an unlocked cabinet.

* Never carry something that can be poisonous, such as a medicine, in a purse where children may find it.



* Safety latches on drawers or cabinets, and child resistant caps on bottles, are helpful in keeping poisons out of the hands of children. But remember, they are not “child-proof” and do not substitute for your careful and constant supervision.





Remember the BEFORE, WHILE and AFTER Rule

BEFORE using a cleaning product, read the instructions on the bottle.


WHILE using a cleaning product, never leave it alone. A child may find it.


AFTER using a product, put it back in a locked cabinet. Make sure the container is closed tightly.


If you are asked to give medicine to a child, follow the instructions on the bottle. After using the medicine, return the bottle to a safe storage place right away. Never leave a child alone with the medicine.

What information about each child should you have?

Before parents leave you in charge of a child, make sure they write down some basic information such as:

* each child’s age and weight
* any allergies or medical conditions
* their doctor’s name and telephone number
* how the parents can be reached in an emergency



Get Help

If you think someone has been poisoned, call the emergency number right away. Do not wait for the child to look or feel sick. The poison center will tell you what to do to help the child. Make sure you know the poison center’s telephone number. Keep a card or sticker with the poison center’s telephone number, carry it with you on your babysitting jobs and save the number in your cell phone.






Poison Prevention Week
To keep your car safe:

*
Think of your vehicle as your home on wheels. Apply the same poison prevention tips that work at home to your automobile.
*
Keep automotive products and car cleaner products in their original containers. Don't, for example, put windshield washer fluid in a used plastic water bottle, lest someone accidentally drink it.
*
Keep products locked and out of reach of children. If you don't have a trunk, use a plastic container with a snug top.
*
Give children appropriate toys to play with and not a purse, which can hold pills, caffeine gum, hair spray or other inappropriate products. Same goes for diaper bags.
*
Inspect any packaging you may give a little one to play with on car rides. No plastic bags, for example.


Unintentional Injury Prevention
http://www.cdc.gov/ncipc/duip/duip.htm

The Division of Unintentional Injury Prevention in CDC's Injury Center monitors trends in unintentional injuries in the United States, conducts research to better understand risk factors, and evaluates interventions to prevent these injuries. Research and prevention programs focus on two categories of unintentional injury: motor vehicle-related injuries and home and recreation related injuries.



Unintentional Injury Prevention

The Division of Unintentional Injury Prevention in CDC's Injury Center monitors trends in unintentional injuries in the United States, conducts research to better understand risk factors, and evaluates interventions to prevent these injuries. Research and prevention programs focus on two categories of unintentional injury: motor vehicle-related injuries and home and recreation related injuries.

Podcasts—Unintentional Injury Prevention



Publications

Fact Sheets about Unintentional Injury Topics

Research Updates (Brief summaries of study findings):

* Car Surfing: A Dangerous, Thrill-Seeking Activity
* CDC Recommends Booster Seats for Children
* Child Passengers Killed in Alcohol-Related Crashes Usually Riding with a Drinking Driver
* Community-Based Interventions to Reduce Motor Vehicle-Related Injuries
* Effectiveness of Designated Driver Promotion Programs to Reduce Alcohol-Impaired Driving is Unknown
* Feasibility of Expanding NEISS to Monitor Nonfatal Injuries Treated in US Emergency Departments
* Graduated Driver Licensing Reduces Risk of Young Driver Crashes
* Implementing impaired driving countermeasures: Putting research into action
* Motor Vehicle-Related Injuries Among Older Adults: A Growing Public Health Concern
* Primary Enforcement Laws Reach Groups Least Likely to Use Safety Belts
* Reducing Motor Vehicle Crashes Among Young Drivers
* Research Update: Lessons from CDC’s Smoke Alarm Installation and Fire Safety Education Program
* School-based Programs Reduce Riding with Alcohol-impaired Drivers
* Sobriety Checkpoints Are Effective in Reducing Alcohol-Related Crashes
* Stronger State DUI Prevention Activities May Reduce Alcohol-Impaired Driving
* The Choking Game: CDC’s Findings on a Risky Youth Behavior

Publications Available Online or for Order

* Activity Report 2004: CDC’s Unintentional Injury Prevention Program
* Activity Report 2001: CDC’s Unintentional Injury Prevention Program
* Atlas of Injury Mortality Among American Indian and Alaska Native Children and Youth
* Bicycle Helmet Recommendations
* Check for Safety: A Home Fall Prevention Checklist for Older Adults - included in tool kit (also available in Spanish).
* Demonstrating Your Program's Worth: A Primer on Evaluation for Programs to Prevent Unintentional Injury
* Efforts to Increase Smoke Detector Use in U.S. Households
* Home and Leisure Injuries in the United States: A Compendium of Articles from the Morbidity and Mortality Weekly Report 1985-1999
* Injury Mortality Among American Indian and Alaska Native Children and Youth, 1989–1998
MMWR Article
Fact Sheet
* Major Causes of Unintentional Injuries Among Older Persons
* National Strategies for Advancing Child Pedestrian Safety
* Nonfatal Choking-Related Episodes Among Children --- United States, 2001
* Prevention of Motor Vehicle-Related Injuries: A Compendium of Articles from the Morbidity and Mortality Weekly Report 1985-1996
* U.S. Fall Prevention Programs for Seniors
Selected Programs Using Home Assessment and Modification
* Unpowered Scooter-Related Injuries --- United States, 1998--2000
* What YOU Can Do To Prevent Falls - included in tool kit (also available in Spanish)


Spotlights

* Click It or Ticket
* Child Passenger Safety Week
* Choking Episodes Among Children
* Dog Bite Prevention Week
* Drunk and Drugged Driving Prevention
* Fire Prevention Week
* Fireworks Safety Month
* International Day of Older Persons
* Walk to School Day
* World Day of Remembrance for Road Traffic Victims
* Community-Based Interventions to Reduce Motor Vehicle-Related Injuries
* Safe Boating Week
* Teens Behind the Wheel: Graduated Driver Licensing
* World Health Day 2004








* Links to non-Federal organizations found at this site are provided solely as a service to our users. These links do not constitute an endorsement of these organizations or their programs by CDC or the Federal Government, and none should be inferred. CDC is not responsible for the content of the individual organization Web pages found at these links.

PDF Document Icon Please note: Some of these publications are available for download only as *.pdf files. These files require Adobe Acrobat Reader in order to be viewed. Please review the information on downloading and using Acrobat Reader software.
Content Source: National Center for Injury Prevention and Control, Division of Unintentional Injury Prevention
Page last modified: October 23, 2008
Page Located on the Web at http://www.cdc.gov/ncipc/duip/duip.htm
Department of Health and Human Services



Additional Information Regarding Disposal of Medications
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5910a8.htm?s_cid=mm5910a8_e
Weekly
March 19, 2010 / 59(10);302

In the report, Adult Use of Prescription Opioid Pain Medications Utah, 2008, in the last paragraph of the Editorial Note (page 156), a reference is made to Food and Drug Administration recommendations for the appropriate disposal of leftover medications from the household if the local community does not have a medication disposal or "take back" program. These guidelines include a list of medications with special labeling directions recommending they be disposed of by flushing down the sink or toilet. This method for disposal is recommended because a number of potent opioids are included on the list, and these medications can be harmful, even fatal, if taken accidentally. The guidelines and list are available at http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htmExternal Web Site Icon.
Disposal by Flushing of Certain Unused Medicines: What You Should Know

* Overview
* Frequently Asked Questions
* List of Medicines Recommended for Disposal by Flushing

Medicines play an important role in treating certain conditions and diseases, but they must be taken with care. Unused portions of these medicines must be disposed of properly to avoid harm. Almost all medicines can be thrown away in the household trash after mixing them with some unpalatable substance (e.g., coffee grounds) and sealing them in a container.

However, certain medicines may be especially harmful and, in some cases, fatal in a single dose if they are used by someone other than the person the medicine was prescribed for. For this reason, a few medicines have special disposal directions that indicate they should be flushed down the sink or toilet after the medicine is no longer needed. If you dispose of these medicines down the sink or toilet, they cannot be accidently used by children, pets, or anybody else.

You may have also received disposal directions for these medicines when you picked up your prescription. If your medicine is on this list, and you did not receive information on disposal with your prescription, you can find directions on how to dispose of the medicines at DailyMed1. After you search on the drug name, the disposal information for these medicines can be found in one of the following sections of the prescribing information:

* Information for Patients and Caregivers
* Patient Information
* Patient Counseling Information
* Safety and Handling Instructions
* Medication Guide

It is important to note that disposal by flushing is not recommended for the vast majority of medicines. Unused or expired medicines that do not have flushing directions in the label can be disposed of safely in the household trash by:

1. Mixing them with something that will hide the medicine or make it unappealing, such as kitty litter or used coffee grounds.
2. Placing the mixture in a container such as a sealed plastic bag.
3. Throwing the container in your household trash.

Below is some additional information about the disposal of medicine that is no longer needed. If you have additional questions about disposing of your medicine, please contact us at 1-888-INFO-FDA (1-888-463-6332).

Frequently Asked Questions

Why do the medications on the list have flushing directions for disposal?

The medicines on this list of medicines recommended for disposal by flushing are safe and effective when used as prescribed, but they could be especially harmful to a child, pet, or anyone else if taken accidentally. Some of the possible harmful effects include breathing difficulties or heart problems, possibly leading to death. For these reasons, FDA advises that flushing these medicines down the sink or toilet is currently the best way to immediately and permanently remove the risk of harm from the home.

FDA continues to work with and encourage the manufacturers of these medicines to develop alternative, safe disposal systems.

How should you dispose of medicines not found on the list?

Do not flush all medicines down the toilet. The FDA recommends that most medicines be disposed of in the household trash after mixing them with some unpalatable substance (e.g., coffee grounds) and sealing them in a container. Unused portions of medicines must be disposed of properly to avoid harm.

Drug take-back programs for disposal can be another good way to remove unwanted or expired medicines from the home and reduce the chance that someone may accidentally take the medicine. Contact your city or county government's household trash and recycling service to see if there is a take-back program in your community and if there are any rules about which medicines can be taken back. You can also talk to your pharmacist to see if he or she knows of other medicine disposal programs in your area.

Does flushing the medicines on the list down the toilet or sink drain pose a risk to human health and the environment?

We are aware of recent reports that have noted trace amounts of medicines in the water system. The majority of medicines found in the water system are a result of the body’s natural routes of drug elimination (in urine or feces). Scientists, to date, have found no evidence of harmful effects to human health from medicines in the environment.

Disposal of these select, few medicines by flushing contributes only a small fraction of the total amount medicine found in the water. FDA believes that any potential risk to people and the environment from flushing this small, select list of medicines is outweighed by the real possibility of life-threatening risks from accidental ingestion of these medicines.


MEDICINES RECOMMENDED FOR DISPOSAL BY FLUSHING

This list from FDA tells you what unused or expired medicines you should flush down the sink or toilet to help prevent danger to people and pets in the home. Flushing these medicines will get rid of them right away and help keep your family and pets safe.

FDA continually evaluates medicines for safety risks and will update the list as needed.
Medicine Active Ingredient
Actiq, oral transmucosal lozenge Fentanyl Citrate
Avinza, capsules (extended release) Morphine Sulfate
Daytrana, transdermal patch system Methylphenidate
Demerol, tablets * Meperidine Hydrochloride
Demerol, oral solution * Meperidine Hydrochloride
Diastat/Diastat AcuDial, rectal gel Diazepam
Dilaudid, tablets * Hydromorphone Hydrochloride
Dilaudid, oral liquid * Hydromorphone Hydrochloride
Dolophine Hydrochloride, tablets * Methadone Hydrochloride
Duragesic, patch (extended release) * Fentanyl
Embeda, capsules (extended release) Morphine Sulfate; Naltrexone Hydrochloride
Fentora, tablets (buccal) Fentanyl Citrate
Kadian, capsules (extended release) Morphine Sulfate
Methadone Hydrochloride, oral solution * Methadone Hydrochloride
Methadose, tablets * Methadone Hydrochloride
Morphine Sulfate, tablets (immediate release) * Morphine Sulfate
Morphine Sulfate, oral solution * Morphine Sulfate
MS Contin, tablets (extended release) * Morphine Sulfate
Onsolis, soluble film (buccal) Fentanyl Citrate
Opana, tablets (immediate release) Oxymorphone Hydrochloride
Opana ER, tablets (extended release) Oxymorphone Hydrochloride
Oramorph SR, tablets (sustained release) Morphine Sulfate
Oxycontin, tablets (extended release) * Oxycodone Hydrochloride
Percocet, tablets * Acetaminophen; Oxycodone Hydrochloride
Percodan, tablets * Aspirin; Oxycodone Hydrochloride
Xyrem, oral solution Sodium Oxybate

*These medicines have generic versions available or are only available in generic formulations.

List revised: August 2009



For specific drug product labeling information, go to DailyMed2 or Drugs@FDA3.

-
Additional Resources

* New FDA Web Page Lists Disposal Instructions for Select Medicines4
* How to Dispose of Unused Medicines5
* Medication Disposal: Questions and Answers6
* Federal Guidelines for Proper Disposal of Drugs7
* Environmental Protection Agency8

-

Sunday, March 14, 2010

Hydrolyzed Vegetable Protein Product Recalls
http://www.fda.gov/Safety/Recalls/MajorProductRecalls/HVP/default.htm
* als, & Safety Alerts
* > Major Product Recalls


*
Current Page is:Hydrolyzed Vegetable Protein Containing Products Recalls

-
Resources for You

* FoodSafety.gov

-
-
Hydrolyzed Vegetable Protein Product Recalls

The U.S. Food and Drug Administration is actively investigating findings of Salmonella Tennessee in hydrolyzed vegetable protein (HVP) manufactured by Basic Food Flavors, Inc., in Las Vegas, NV. HVP is a flavor enhancer used in a wide variety of processed food products, such as soups, sauces, chilis, stews, hot dogs, gravies, seasoned snack foods, dips, and dressings. It is often blended with other spices to make seasonings that are used in or on foods.



At this time, no illnesses associated with this contamination have been reported to the FDA.



For more information:

* FDA's Comment on Form 483 Detailing Agency’s Inspectional Observations1
* FDA Form 483 (Inspectional Observations: Basic Food Flavors)2 [PDF - 1MB]
* Read the press release3 about the HVP recall.
* Read the transcript of the media briefing4 [PDF - 68KB].
* Search the database of recalled products5 containing HVP.
* Read information for consumers6 about the HVP recall.
* Potential Salmonella contamination - Certain products manufactured in the USA and Canada containing Hydrolysed Vegetable Protein (HVP)7 (Canadian Food Inspection Agency)





*
-
For Consumers: The HVP Recall



The FDA is taking steps to protect the public following the early identification of Salmonella in one company’s supply of a common processed food ingredient.



At this time, no illnesses are known to be associated with this problem of contamination.



To prevent illnesses from occurring, FDA is advising industry about which products to recall and providing consumers with recommendations.



What is HVP?



HVP stands for hydrolyzed vegetable protein, a substance used in small amounts to add flavor to many commercially processed foods, such as soups, hot dogs, chilis, stews, dips, salad dressings, gravies, frozen dinners, and snack foods.



What products are affected?



FDA has posted a searchable website of products affected by the recall online at www.FoodSafety.gov1. This website will updated as more product are recalled.



What I can I do?



FDA is recommending that consumers should:

*
o Check www.FoodSafety.gov2 for a list of recalled products;
o Remember to follow cooking instructions for all foods;
o Report symptoms of Salmonella or other food-related illness to your local health care professional.



Can I tell whether a product contains HVP from the ingredient list?



Consumers should not rely on the ingredient list to identify products that contain HVP. Consumers with questions about a particular product should contact the manufacturer or visit www.FoodSafety.gov3.



How did FDA identify this problem?



FDA learned of this problem before any disease outbreak occurred. The agency received a report of contamination, inspected the facility and worked to put in place measures to instruct industry and protect consumers. FDA is continuing to assess the situation and may make additional recommendations as more information becomes available.



What is Salmonella?



Salmonella is the name of a group of bacteria and is one of the most common causes of bacterial foodborne illness in the United States. It most commonly fever, diarrhea (which may be blood), nausea, vomiting, and abdominal pain. Consumers who experience any of the symptoms of Salmonella should contact their health care professional.



For the basics on Salmonella (such as sources, symptoms, duration of illness), see the Salmonella page on FoodSafety.gov at: http://www.foodsafety.gov/poisoning/causes/bacteriaviruses/salmonella.html4.





-
Additional Information

* FDA Investigation Reveals Salmonella Tennessee at Plant that Makes Flavor Enhancers for Food Processors and Other Distributors5
* HVP: Information for Industry6



Life photo archive
http://images.google.com/hosted/life


P&G Joins Industry Ingredient Recall by Voluntarily Recalling Two Flavors of Pringles® in the United States in Response to FDA Industry Guidance
http://www.fda.gov/Safety/Recalls/ucm203957.htm?s_cid=w_c_sms_cont_001

-
Recall -- Firm Press Release



FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.


P&G Joins Industry Ingredient Recall by Voluntarily Recalling Two Flavors of Pringles® in the United States in Response to FDA Industry Guidance



Media Contact:
Kay Puryear,
513-634-4319
puryear.sk@pg.com



Media Contact:
Paul Fox,
513-983-3465
fox.pd@pg.com



FOR IMMEDIATE RELEASE - March 08, 2010 - CINCINNATI – PRNewswire/ - The Procter & Gamble Company (NYSE:PG), in response to a recommendation from the Food & Drug Administration (FDA) to the food industry, announced today that it is voluntarily recalling Pringles Restaurant Cravers Cheeseburger potato crisps and Pringles Family Faves Taco Night potato crisps as part of an industry ingredient recall to protect consumers from potential Salmonella exposure. There have been no reports of Salmonella-related illness in relation to these products.

P&G was notified by one of its suppliers that a seasoning used in these two products contains hydrolyzed vegetable protein (HVP) manufactured by Basic Food Flavors, Inc., who has voluntarily recalled several lots of this ingredient because of potential salmonella exposure. As a result, the FDA has recommended that food manufacturers recall certain types of products containing HVP manufactured by Basic Food Flavors, and P&G is complying with this guidance.

Only products with the following "best by" dates are being recalled. The "best by" date for each product can be found on the bottom of the can.

Product Name


UPC Code


"Best by" date
Pringles Restaurant Cravers Cheeseburger, Super Stack Canister, 181 grams

37000 26936


02/2011
04/2011
Pringles Family Faves Taco Night, Super Stack Canister,
181 grams

37000 26773


03/2011
04/2011
05/2011

No other Pringles varieties or flavors are affected by this recall. These two products represent only one half of one percent of Pringles' U.S. volume. None of the affected products have been shipped to retailers outside of the United States.

The safety of our products is P&G's top priority, and we follow rigorous food safety and ingredient testing standards. We are withdrawing these products out of an abundance of caution for consumer safety and in response to FDA’s recommendation to the food industry.

Salmonella is a common food borne pathogen that can cause severe illnesses, including fever, abdominal cramps and diarrhea. While most individuals recover without medical intervention, the infection can be life-threatening in some cases such as young children, the elderly and those with compromised immune systems. There have been no reports of Salmonella-related illness to date in relation to these products.

Consumers who have purchased the recalled products should discard the product and call P&G for a replacement coupon or refund at 1-877-876-7881 (Hours of operation: Monday - Friday, 9AM - 6PM US ET).



###





RSS Feed for FDA Recalls Information2 [what's this?3]

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Links on this page:

1. http://www.fda.gov/Safety/Recalls/ucm203975.htm
2. http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/Recalls/rss.xml
3. http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm

Page Last Updated: 03/10/2010




Salmonella and Food recalls
http://www.foodsafety.gov/keep/recalls/index.html
Recent Recalls Associated with Salmonella

Don't eat recalled food! Check these recalled product lists carefully. If you have a product on the list, review the recall notice and follow the manufacturer's instructions for disposing of the product safely.

Salmonella Associated with Foods with Hydrolyzed Vegetable Protein

* Hydrolyzed vegetable protein (HVP) is a flavor enhancer used in processed foods.
* HVP manufactured by Basic Food Flavors has been recalled because of Salmonella. See the consumer alert.
http://www.fda.gov/Food/NewsEvents/WhatsNewinFood/ucm202989.htm
For Consumers: The HVP Recall



The FDA is taking steps to protect the public following the early identification of Salmonella in one company’s supply of a common processed food ingredient.



At this time, no illnesses are known to be associated with this problem of contamination.



To prevent illnesses from occurring, FDA is advising industry about which products to recall and providing consumers with recommendations.



What is HVP?



HVP stands for hydrolyzed vegetable protein, a substance used in small amounts to add flavor to many commercially processed foods, such as soups, hot dogs, chilis, stews, dips, salad dressings, gravies, frozen dinners, and snack foods.



What products are affected?



FDA has posted a searchable website of products affected by the recall online at www.FoodSafety.gov1. This website will updated as more product are recalled.



What I can I do?



FDA is recommending that consumers should:

*
o Check www.FoodSafety.gov2 for a list of recalled products;
o Remember to follow cooking instructions for all foods;
o Report symptoms of Salmonella or other food-related illness to your local health care professional.



Can I tell whether a product contains HVP from the ingredient list?



Consumers should not rely on the ingredient list to identify products that contain HVP. Consumers with questions about a particular product should contact the manufacturer or visit www.FoodSafety.gov3.



How did FDA identify this problem?



FDA learned of this problem before any disease outbreak occurred. The agency received a report of contamination, inspected the facility and worked to put in place measures to instruct industry and protect consumers. FDA is continuing to assess the situation and may make additional recommendations as more information becomes available.



What is Salmonella?



Salmonella is the name of a group of bacteria and is one of the most common causes of bacterial foodborne illness in the United States. It most commonly fever, diarrhea (which may be blood), nausea, vomiting, and abdominal pain. Consumers who experience any of the symptoms of Salmonella should contact their health care professional.



For the basics on Salmonella (such as sources, symptoms, duration of illness), see the Salmonella page on FoodSafety.gov at: http://www.foodsafety.gov/poisoning/causes/bacteriaviruses/salmonella.html4.





-
Additional Information

* FDA Investigation Reveals Salmonella Tennessee at Plant that Makes Flavor Enhancers for Food Processors and Other Distributors5
* HVP: Information for Industry6

-
-
-
Links on this page:

1. http://www.foodsafety.gov/
2. http://www.foodsafety.gov/
3. http://www.foodsafety.gov/
4. http://www.foodsafety.gov/poisoning/causes/bacteriaviruses/salmonella.html
5. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm203067.htm
6. http://www.fda.gov/Food/ResourcesForYou/FoodIndustry/ucm203201.htm

Page Last Updated: 03/04/2010
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.







* No illnesses have been reported.
* HVP is used in a wide variety of food products. Only products made with HVP from Basic Food Flavors are being recalled.
o View the entire list of recalled products.
o Search the database of recalled products.

Salmonella Outbreak Associated with Italian Sausage Products and Red Pepper

* 245 people have been infected from 44 states and DC. Get details on the outbreak and see outbreak map.
* Italian sausage products sold in retail locations have been recalled. Review the list of recalled products and the list of stores that sold these products.
* Crushed red pepper sold to commercial customers has also been recalled. See the recall notice.



innerbody web site
http://www.innerbody.com/htm/body.html




global nytimes web site
http://global.nytimes.com/



Infant Deaths Prompt CPSC Warning About Sling Carriers for Babies
http://www.cpsc.gov/cpscpub/prerel/prhtml10/10165.html
Office of Information and Public Affairs Washington, DC 20207
FOR IMMEDIATE RELEASE
March 12, 2010
Release #10-165 CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908


Infant Deaths Prompt CPSC Warning About Sling Carriers for Babies

WASHINGTON, D.C.- The U.S. Consumer Product Safety Commission (CPSC) is advising parents and caregivers to be cautious when using infant slings for babies younger than four months of age. In researching incident reports from the past 20 years, CPSC identified and is investigating at least 14 deaths associated with sling-style infant carriers, including three in 2009. Twelve of the deaths involved babies younger than four months of age.

Slings can pose two different types of suffocation hazards to babies. In the first few months of life, babies cannot control their heads because of weak neck muscles. The sling’s fabric can press against an infant’s nose and mouth, blocking the baby’s breathing and rapidly suffocating a baby within a minute or two. Additionally, where a sling keeps the infant in a curled position bending the chin toward the chest, the airways can be restricted, limiting the oxygen supply. The baby will not be able to cry for help and can slowly suffocate.

Many of the babies who died in slings were either a low birth weight twin, were born prematurely, or had breathing issues such as a cold. Therefore, CPSC urges parents of preemies, twins, babies in fragile health and those with low weight to use extra care and consult their pediatricians about using slings.

Two months ago, the Commission added slings to the list of durable infant products that require a mandatory standard. Additionally, CPSC staff is actively investigating these products to determine what additional action may be appropriate. Until a mandatory standard is developed, CPSC is working with ASTM International to quickly complete an effective voluntary standard for infant sling carriers.

CPSC recommends that parents and caregivers make sure the infant’s face is not covered and is visible at all times to the sling’s wearer. If nursing the baby in a sling, change the baby’s position after feeding so the baby’s head is facing up and is clear of the sling and the mother’s body. Parents and caregivers should be vigilant about frequently checking their baby in a sling.




McCormick Recall Due to Possible Health Risk from HVP Ingredient Expands to Include Additional "Best By" Dates



-
Recall -- Firm Press Release



FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.


McCormick Recall Due to Possible Health Risk from HVP Ingredient Expands to Include Additional "Best By" Dates



Contact:
McCormick Corporate Communications
Jim Lynn
410-771-7803



FOR IMMEDIATE RELEASE – March 11, 2010 – SPARKS, MD – McCormick & Company, Incorporated (NYSE:MKC) is expanding a March 5, 2010 recall to include additional "Best By" dates of products manufactured with HVP (hydrolyzed vegetable protein) supplied by Basic Food Flavors of Las Vegas, Nevada, because the ingredient has the potential to be contaminated with Salmonella.

"Consumption of products containing Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms) endocarditis and arthritis."

To date, no illnesses have been associated with these McCormick products. For updated information, go to the CDC and FDA websites.

Recalled products were distributed nationwide and sold in retail stores. Two of the recalled products were also distributed for sale in international markets. The following products are being recalled.

McCormick Onion Gravy Mix sold in 0.87-ounce packages, shipped nationwide and outside the U.S.
McCormick Onion Gravy Mix
Under UPC code 52100098807
"BEST BY" Dates
OCT 08 11 OCT 11 11 OCT 17 11 OCT 18 11
NOV 01 11 NOV 03 11 NOV 15 11 NOV 17 11
DEC 01 11 DEC 02 11 DEC 28 11 DEC 29 11
JAN 22 12 JAN 23 12 JAN 26 12 JAN 30 12
FEB 12 12 FEB 13 12
Additional "Best By" Dates
OCT 7 11 OCT 9 11 OCT 10 11 OCT 16 11
NOV 2 11 NOV 16 11 JAN 29 12



McCormick Vegetable Dip Mix sold in 1.25-ounce packages, shipped nationwide.
McCormick Vegetable Dip Mix
Under UPC code 52100063850
"BEST BY" Dates
JUN 08 11 JUL 09 11 JUL 28 11
Additional "Best By" Date
JUL 08 11



McCormick Corn Bread Stuffing sold in 42-ounce (2 lb. 10 oz.) containers, shipped to Alabama, Florida, Georgia, Pennsylvania and also to Louisiana, Texas.
McCormick Corn Bread Stuffing
Under UPC code 5210057199
Product Codes
4519BH 4520BH 5019BH
Additional Product Code
4520AH



McCormick French Onion Dip Mix sold in 0.53-ounce packages, shipped nationwide and outside the U.S.
McCormick French Onion Dip Mix
Under UPC code 52100168609
"BEST BY" Dates
OCT 06 11 OCT 07 11 NOV 03 11 NOV 06 11
DEC 04 11 JAN 04 12 JAN 23 12



Contact the McCormick Consumer Hotline at 1-800-632-5847 or consumer_affairs@mccormick.com for a replacement or reimbursement. Live assistance is available on the Hotline from 9:30 a.m. to 9:00 p.m. EST, Monday through Friday and 11:00 a.m. to 7:00 p.m. EST on Saturday and Sunday.



###



RSS Feed for FDA Recalls Information1 [what's this?2]




http://movies.nytimes.com/ref/movies/reviews/



http://www.npsa.nhs.uk/

Saturday, March 13, 2010

customer advisory re the Landmark at Ayala Center, Makati.
On March 8, 2010, security lapses occurred at two entrances to said Landmark. Because of said security lapses, I could twice have brought deadly weapons into
said Landmark, to the detriment of customers inside.Then, when I deposited my large luggage at what was identified as the baggage counter at the Food court
level of said Landmark, the employee, at said counter, accepted said luggage without first inspecting the contents of said luggage. Said luggage was large
enough to contain deadly weapons. Then, said employee gave me a claim tag without the word "Makati" on it. Without said word on said tag, I couldn't prove
that said tag was issued at Makati, since there is also a Landmark store in Quezon City. at the Landmark building, Ayala Center, Makati. On March 8, 2010, said store sold to me malunggay cookies, from Power Nut. Said cookies did not bear visible, to
unaided eyes, expiration date/consume before date/best before date. Also, the packaging of said product bore the words “BFAD LICENSED” but did not bear the alleged number of said alleged BFAD license.


While I was at the Food Court level at Landmark Makati, there were no required visible express lane for senior citizens and no sign re privileges for senior
citizens at the KFC restaurant and the Greenwich restaurant at said Food Court, contrary to the implementing rules and regulations of the Expanded Senior Citizens Act of 2003. An employee at said Greenwich restaurant didn't have a required health certificate attached at the upper left of the clothing he was wearing. Then, the food sold to me by said employee contained a container with what was identified as catsup on the same plate as exposed pork. So the germs from said container could
contaminate said pork. Also, the spoons and forks near said restaurant were not warm to the touch.



customer advisory re Chowking restaurant and KFC restaurant at Robinsons Ermita. On March 9, 2010, when I went at approximately 11:40 A.M. to said Chowking
restaurant, there was no visible express lane for senior citizens and no visible sign in the customer area of said restaurant regarding the privileges of senior citizens, contrary to the implementing rules and regulations of the Expanded Senior Citizens Act of 2003. When I went, at approximately 12:40 P.M. to said KFC restaurant, there was no visible express lane for senior citizens and no visible sign in the customer area of said restaurant regarding the privileges of senior citizens, contrary to the implementing rules and regulations of the Expanded Senior Citizens Act of 2003.





web site with useful information:

http://www.emedicinehealth.com/

Thursday, March 4, 2010

On March 4, 2010, the security guards at the entrance to
SM Makati at Ayala Center, Makati, didn't inspect/subject my luggage to scanning.
Said luggage was large enough to contain deadly weapons.

The guard, at the entrance to SM Supermarket at SM
Building at Ayala Center, Makati, didn't inspect my
luggage/subject it to scanning.Said luggage was large enough
to contain deadly weapons.The guard at entrance to
SM Appliances at SM Building, Makati, didn't inspect
my luggage/subject my luggage to scanning. Said luggage
was large enough to contain deadly weapons.

On March 4, 2010, when I went to the Chow King restaurant, at SM Makati building at
Ayala Center, Makati, employee,identified as "Julie Ann" didn't have
the required health certificate attached to the upper left
of the clothing she was wearing. Also, while I was at said restaurant,
there was no visible required express lane for senior citizens and required
sign regarding privileges for senior citizens, contrary to implementing
rules and regulations of the Expanded Senior Citizens Act of 2003.

web sites with useful free information:

http://www.healthdialog.com/Main/default

http://repairpal.com/

http://www.steves-digicams.com/knowledge-center/

_____________________________________________________________________________________
U.S. Food and Drug Administration warning letters
http://www.fda.gov./ICECI/EnforcementActions/WarningLetters/default.htm#recent

*
Recently Posted Warning Letters

Posted on March 03, 2010

Letter Issue Date Company Name Issuing Office Subject Close Out Date
February 23, 2010 Pom Wonderful25 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Dreyer's Ice Cream Inc.26 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Sunsweet Growers Inc.27 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Spectrum Organic Products, Inc.28 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Pbm Products, LLC29 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Redco Foods, Inc.30 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 First Juice31 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Beech-Nut Nutrition Corporation32 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Diamond Food Inc.33 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Ken's Foods, Inc.34 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Fleminger Inc35 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Gorton's, Inc.36 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Pompeian, Inc.37 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Guangzhou Yong Want Foods Ltd38 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Gerber Products Co39 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Schwan's Consumer Brands40 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
December 04, 2009 Nestle USA41 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Misbranded Not Issued *

Posted on March 02, 2010
Letter Issue Date Company Name Issuing Office Subject Close Out Date
February 24, 2010 Centrix Pharmaceutical Inc42 New Orleans District Office New Drug/Adulterated Not Issued *
February 23, 2010 HMI Industrries, Inc.43 Cincinnati District Office CGMP/QSR/Adulterated/Misbranded Not Issued *
February 18, 2010 Stardust Dairy, LLC44 Cincinnati District Office Animal Sale for Slaughter as Food/Adulterated Not Issued *
February 18, 2010 Vertical Pharmaceuticals, Inc.45 New Jersey District Office Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Body Tools46 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 King Cone International47 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Amasha48 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Indian Mountain Center49 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Bobalee Originals Manufacturing50 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 International Ear Candle, LLC51 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Home Remedies Solutions52 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Harmony Cone53 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 A.J.'s Candles, Inc54 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Wholistic Health Solutions55 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Health, Wealth, & Happiness56 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 White Egret, Inc.57 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Wally's Natural Products, Inc.58 San Francisco District Office Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Brennan And Mccoy59 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Herbs, Heirlooms and Homebrew60 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 16, 2010 La Mexicana, Inc.61 Seattle District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Misbranded/Insanitary Conditions Not Issued *
February 16, 2010 Biological Controls62 New Jersey District Office CGMP/QSR/Adulterated/Misbranded Not Issued *
February 16, 2010 Crestview Calves, Inc.63 Seattle District Office Animal Sale for Slaughter as Food/Adulterated Not Issued *
February 16, 2010 Gourmet Express Marketing, Inc.64 Chicago District Office Seafood HACCP/CGMP/Misbranded Not Issued *
February 11, 2010 Rangen Inc65 Seattle District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded Not Issued *
February 08, 2010 Magna Pharmaceuticals, Inc66 Cincinnati District Office Labeling/False & Misleading Claims/New Drug/Misbranded Not Issued *
February 08, 2010 Poly Pharmaceuticals, Inc67 New Orleans District Office New Drug/Adulterated Not Issued *
January 13, 2010 Innovative Beverage Groups Holdings, Inc68 Dallas District Office Labeling/Adulterated Not Issued *
October 28, 2009 Juices International69 New York District Office CGMP for Foods/Juice HACCP/Adulterated Not Issued *
October 05, 2009 Mystical One LLC70 New York District Office CGMP for Foods/Juice HACCP/Adulterated Not Issued *
-


Page Last Updated: 01/28/2010

_____________________________________________________________________________________
U.S. Food and Drug Administration warning letter to Gerber
http://www.fda.gov./ICECI/EnforcementActions/WarningLetters/ucm202821.htm
Gerber Products Co

Department of Health and Human Services logoDepartment of Health and Human Services
Public Health Service
Food and Drug Administration
College Park, MD 20740

FEB 22 2010


WARNING LETTER



VIA OVERNIGHT MAIL


Mr. Kurt Schmidt
Business Head
Nestle Nutrition
North American Headquarters
12 Vreeland Road
Florham Park, NJ 07932


Re: CFSAN-OC-10-09


Dear Mr. Schmidt:

The Food and Drug Administration (FDA) has reviewed the labels for the products in your Gerber Graduates Fruit Puffs line and the label of your Gerber 2nd Foods Carrots product, as well the labeling for these products on your website, www.gerber.com. Based on our review, we have concluded that these products are in violation of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and regulations on FDA's website at www.fda.gov.

The products in your Gerber Graduates Fruit Puffs line are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because their labeling includes unauthorized nutrient content claims. Except for claims regarding the percentage of a vitamin or mineral for which there is an established Reference Daily Intake (RDI), a nutrient content claim may not be made for a food intended specifically for use by infants and children less than 2 years of age unless the claims is specifically provided for in parts 101, 105, or 107 of FDA regulations. 21 CFR 101.13(b)(3). Your Graduates Fruit Puffs products are specifically intended for infants and children under age 2. For example, the labeling indicates that the products are designed for the "crawler" stage of a child's life. The labeling for these products includes nutrient content claims such as "good source of iron, zinc, and vitamin E for infants and toddlers." The circumstances under which "good source" claims are permitted are defined in 21 CFR 101.54. That regulation does not allow such claims for foods intended specifically for infants and children under 2.

Your 2nd Foods Carrots product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because its labeling includes unauthorized nutrient content claims. This product is also intended specifically for infants and children under the age of two. For example, its labeling states that the product is appropriate for a "sitter," and sitting is a developmental milestone that generally occurs by the age of one. The 2nd Foods Carrots product label bears the nutrient content claim "healthy" as part of the statement "As Healthy as Fresh," and nutrient content claims such as "Excellent Source ... of Vitamin A" and "No Added Sugar." These circumstances under which such claims are permitted are defined in 21 CFR 101.65(d), 21 CFR 101.54(b), and 21 CFR 101.60(c). However, these regulations do not allow the claim for products specifically intended for children under two years of age.

The above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. It is your responsibility to ensure that your firm and all of your products are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory actions without further notice, such as seizure and/or injunction.

You should take prompt action to correct these violations. Please respond to this letter within 15 days from receipt with the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violations and prevent similar violations. Include any documentation necessary to show that correction has been achieved. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

You should direct your written reply to Kathleen M. Lewis, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835.


Sincerely,
/S/

Roberta F. Wagner
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition


cc: FDA New Jersey District
FDA Detroit District

Mr. Mark E. Shipley
Plant Manager
Gerber Products Company
405 E. State Street
Fremont, MI 49412
_____________________________________________________________________________________________________________________________________________________________________
U.S. Food and Drug Administration warning letter to Nestle
http://www.fda.gov./ICECI/EnforcementActions/WarningLetters/ucm194122.htm
Nestle USA, 12/4/09

Department of Health and Human Services' logoDepartment of Health and Human Services
Public Health Service
Food and Drug Administration
College Park, MD 20740

DEC 04 2009





Brad Alford, Chairman and CEO
Nestle U.S.A.
800 North Brand Boulevard
Glendale, CA 91203

WARNING LETTER



Re: CFSAN-OC-10-05

Dear Mr. Alford:

The Food and Drug Administration (FDA) has reviewed the labeling for several Nestle Juicy Juice products: Juicy Juice Brain Development Fruit Juice Beverage (Apple), Juicy Juice All-Natural 100% Juice Orange Tangerine, and Juicy Juice All-Natural 100% Juice Grape. Based on our review, we have concluded that these products are misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 343] because their labeling deviates from the requirements of the Act and FDA regulations at Title 21 of the Code of Federal Regulations.

Your Juicy Juice Brain Development Fruit Juice Beverage product is misbranded within the meaning of section 403(r) of the Act [21 USC 343(r)] because its labeling includes unauthorized nutrient content claims. Except for statements that describe the percentage of a vitamin or mineral in relation to a Reference Daily Intake (RDI), a nutrient content claim cannot be made for a food intended for use by infants and children less than 2 years of age unless the claim is specifically provided for in parts 101, 105, or 107 of FDA regulations. 21 CFR 101.13(b)(3). This product is marketed specifically for children under two years of age, as indicated by the claim "Helps support brain development***In children under two years old," which appears on the product label. The label also bears the nutrient content claim "no sugar added." The circumstances under which a "no sugar added" claim is permitted are defined in 21 CFR 101.60(c). That regulation does not allow the claim for conventional food products intended for use in children under age 2. 21 CFR 101.60(c)(4). Therefore, the claim "no sugar added" misbrands your product.

On October 30, 2009. we also reviewed your website, http://www.juicyjuice.com. the address of which is listed on the Juicy Juice Brain Development Fruit Juice Beverage label. The labeling found on your website makes an additional unauthorized nutrient content claim, which
further misbrands the product. The website claims that Juicy Juice Brain Development Fruit Juice Beverage is "naturally lower in sugar." As noted above, except for statements that describe the percentage of a vitamin or mineral in relation to an RDI, no nutrient content claims can be made for a food intended specifically for use by infants and children less than 2 years of age unless specifically permitted by FDA regulations. 21 CFR 101.13(b)(3). The circumstances under which a "lower in sugar" claim is permitted are defined in 21 CFR 101.60(c)(5). That regulation does not allow the use of the claim for food products intended for use in children under age 2.

Additionally, we have reviewed the labeling of your Nestle Juicy Juice All Natural 100% Juice Orange Tangerine and Nestle Juicy Juice All Natural 100% Juice Grape products. These products are misbranded under section 403(a)(1) of the Act [21 USC 343(a)(1)] because their labels are misleading. The label of the Orange Tangerine product is designed to imply that the product is 100% orange/tangerine juice, and the label of the Grape product is designed to imply that product is 100% grape juice. The principal display panels identify the products as "Orange Tangerine" and "Grape," respectively, in large, bold lettering outlined in black; however, neither orange/tangerine juice nor grape juice is the predominant juice in the products.The statements "All Natural-100% Juice" in close proximity to the words "Orange Tangerine"or "Grape" and vignettes of oranges or grapes also may lead consumers to believe that the products are 100% orange/tangerine juice or 100% grape juice when, in fact, they are not. The separate statement at the base of the respective principal display panels, "Flavored juice blend from concentrate with other natural flavors & added ingredients," appears in a smaller font and white print on a colored background. The manner in which the latter statement is presented makes it less conspicuous and prominent than the other label statements and vignettes and therefore less likely to be read or understood by consumers at the time of purchase.

The above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. It is your responsibility to ensure that all of your products are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory actions without further notice, such as seizure and/or injunction.

You should take prompt action to correct these violations. Please respond to this letter within 15 days from receipt with the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violations and prevent similar violations. Include any documentation necessary to show that correction has been achieved. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

You should direct your written reply to Quyen Tien, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Brooch Parkway, Office of Compliance (HFS608), Division of Enforcement, College Park, Maryland 20740-3835.

Sincerely,

/S/



Roberta F. Wagner
Director
Office of Compliance
Center for Food Safety and Applied Nutrition



cc: FDA Los Angeles District Office

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Page Last Updated: 03/03/2010

image of registry return receipt of letter addressed to Makati councilor J. J. Binay

image of registry return receipt of letter addressed to Makati councilor J. J. Binay