Advisory vs. Lucy Torres Gomez and her claims regarding Guerlain's Orchidee Imperiale Exceptional Complete Care Cream. Said claims were published on page F-1 of the September 3, 2008 issue of the Philippine Star newspaper. The claims were: It is an exceptional comprehensive anti-aging skincare product that will cover your needs - it will make your skin recover its strength, you facial contours regain definition, your skin texture is refined, wrinkles and lines are smoother, and your complexion will be more luminous. What evidence, if any, is there, that using said product will produce said results? How much of said product has to be used and how often should said product be used to achieve said results? If said product does not produce said results, will said Lucy Torres Gomez compensate the customers who bought said product?

Bottled Water Everywhere: Keeping it Safe
http://www.fda.gov/consumer/updates/bottledwater082508.html

U.S. consumers have a big thirst for bottled water, buying more than 8 billion gallons of it in 2007 alone, according to the International Bottled Water Association.

The U.S. Food and Drug Administration (FDA) regulates bottled water products, working to ensure that they're safe to drink.

FDA protects consumers of bottled water through the Federal Food, Drug, and Cosmetic Act (FD&C Act), which makes manufacturers responsible for producing safe, wholesome, and truthfully labeled food products.

There are regulations that focus specifically on bottled water, including

* "standard of identity" regulations that define different types of bottled water
* "standard of quality" regulations that set maximum levels of contaminants—including chemical, physical, microbial and radiological contaminants—allowed in bottled water
* "current good manufacturing practice" (CGMP) regulations that require bottled water to be safe and produced under sanitary conditions


Types of Bottled Water

FDA describes bottled water as water that's intended for human consumption and sealed in bottles or other containers with no added ingredients, except that it may contain a safe and suitable antimicrobial agent. (Fluoride may also be added within the limits set by FDA.)

The agency classifies some bottled water by its origin. Here are four of those classifications:

* Artesian well water. This water is collected from a well that taps an aquifer—layers of porous rock, sand and earth that contain water—which is under pressure from surrounding upper layers of rock or clay. When tapped, the pressure in the aquifer, commonly called artesian pressure, pushes the water above the level of the aquifer, sometimes to the surface. Other means may be used to help bring the water to the surface.
* Mineral water. This water comes from an underground source and contains at least 250 parts per million total dissolved solids. Minerals and trace elements must come from the source of the underground water. They cannot be added later.
* Spring water. Derived from an underground formation from which water flows naturally to the surface, this water must be collected only at the spring or through a borehole that taps the underground formation feeding the spring. If some external force is used to collect the water through a borehole, the water must have the same composition and quality as the water that naturally flows to the surface.
* Well water. This is water from a hole bored or drilled into the ground, which taps into an aquifer.

Bottled water may be used as an ingredient in beverages, such as diluted juices or flavored bottled waters. However, beverages labeled as containing "sparkling water," "seltzer water," "soda water," "tonic water," or "club soda" aren't included as bottled water under FDA's regulations. These beverages are instead considered to be soft drinks.


It May Be Tap Water

Some bottled water also comes from municipal sources—in other words, the tap. Municipal water is usually treated before it is bottled. Examples of water treatments include

* Distillation. Water is turned into a vapor, leaving minerals behind. Vapors are then condensed into water again.
* Reverse osmosis. Water is forced through membranes to remove minerals.
* Absolute 1 micron filtration. Water flows through filters that remove particles larger than one micron—.00004 inches—in size. These particles include Cryptosporidium, a parasitic pathogen that can cause gastrointestinal illness.
* Ozonation. Bottlers of all types of waters typically use ozone gas, an antimicrobial agent, instead of chlorine to disinfect the water. (Chlorine can add residual taste and odor to the water.)

Bottled water that has been treated by distillation, reverse osmosis, or another suitable process may meet standards that allow it to be labeled as "purified water."


Ensuring Quality and Safety

Federal quality standards for bottled water were first adopted in 1973. They were based on U.S. Public Health Service standards for drinking water set in 1962.

The 1974 Safe Drinking Water Act gave regulatory oversight of public drinking water (tap water) to the U.S. Environmental Protection Agency (EPA). FDA subsequently took responsibility, under the FD&C Act, for ensuring that the quality standards for bottled water are compatible with EPA standards for tap water.

Now each time the EPA establishes a standard for a contaminant, FDA either adopts it for bottled water or finds that the standard isn't necessary for bottled water.

In some cases, standards for bottled water and tap water differ. For example, because lead can leach from pipes as water travels from water utilities to home faucets, EPA has set its limit for lead in tap water at 15 parts per billion (ppb). For bottled water, for which lead pipes aren't used, the lead limit is set at 5 ppb.

For bottled water production, bottlers must follow the CGMP regulations put in place and enforced by FDA. Water must be sampled, analyzed, and found to be safe and sanitary. These regulations also require proper plant and equipment design, bottling procedures, and recordkeeping.

In addition, FDA oversees inspections of bottling plants. The agency inspects bottled water plants under its general food safety program and has states perform some plant inspections under contract. (Some states also require bottled water firms to be licensed annually.)

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.
For More Information

FDA Center for Food Safety and Applied Nutrition
Bottled Water Regulations
www.cfsan.fda.gov/~lrd/bot-h2o.html



Date Posted: August 25, 2008




The British Psychological Society web site
http://www.bps.org.uk/


FDA 101: Dietary Supplements
http://www.fda.gov/consumer/updates/supplements080408.html

On this page:

* Talk with a Health Care Professional
* How Are Supplements Regulated?
* Are Supplements Safe?
* Be a Safe and Informed Consumer
* Report Problems

The law defines dietary supplements in part as products taken by mouth that contain a "dietary ingredient." Dietary ingredients include vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet.

Dietary supplements come in many forms, including tablets, capsules, powders, energy bars, and liquids. These products are available in stores throughout the United States, as well as on the Internet. They are labeled as dietary supplements and include among others

* vitamin and mineral products
* "botanical" or herbal products—These come in many forms and may include plant materials, algae, macroscopic fungi, or a combination of these materials.
* amino acid products—Amino acids are known as the building blocks of proteins and play a role in metabolism.
* enzyme supplements—Enzymes are complex proteins that speed up biochemical reactions.

People use dietary supplements for a wide assortment of reasons. Some seek to compensate for diets, medical conditions, or eating habits that limit the intake of essential vitamins and nutrients. Other people look to them to boost energy or to get a good night's sleep. Postmenopausal women consider using them to counter a sudden drop in estrogen levels.


Talk with a Health Care Professional

The Food and Drug Administration (FDA) suggests that you consult with a health care professional before using any dietary supplement. Many supplements contain ingredients that have strong biological effects, and such products may not be safe in all people.

If you have certain health conditions and take these products, you may be putting yourself at risk. Your health care professional can discuss with you whether it is safe for you to take a particular product and whether the product is appropriate for your needs. Here is some general advice:

* Dietary supplements are not intended to treat, diagnose, cure, or alleviate the effects of diseases. They cannot completely prevent diseases, as some vaccines can. However, some supplements are useful in reducing the risk of certain diseases and are authorized to make label claims about these uses. For example, folic acid supplements may make a claim about reducing the risk of birth defects of the brain and spinal cord.
* Using supplements improperly can be harmful. Taking a combination of supplements, using these products together with medicine, or substituting them in place of prescribed medicines could lead to harmful, even life-threatening, results.
* Some supplements can have unwanted effects before, during, or after surgery. For example, bleeding is a potential side effect risk of garlic, ginkgo biloba, ginseng, and Vitamin E. In addition, kava and valerian act as sedatives and can increase the effects of anesthetics and other medications used during surgery. Before surgery, you should inform your health care professional about all the supplements you use.


How Are Supplements Regulated?

You should know the following if you are considering using a dietary supplement.

* Federal law requires that every dietary supplement be labeled as such, either with the term "dietary supplement" or with a term that substitutes a description of the product's dietary ingredient(s) for the word "dietary" (e.g., "herbal supplement" or "calcium supplement").
* Federal law does not require dietary supplements to be proven safe to FDA's satisfaction before they are marketed.
* For most claims made in the labeling of dietary supplements, the law does not require the manufacturer or seller to prove to FDA's satisfaction that the claim is accurate or truthful before it appears on the product.
* In general, FDA's role with a dietary supplement product begins after the product enters the marketplace. That is usually the agency's first opportunity to take action against a product that presents a significant or unreasonable risk of illness or injury, or that is otherwise adulterated or misbranded.
* Dietary supplement advertising, including ads broadcast on radio and television, falls under the jurisdiction of the Federal Trade Commission.
* Once a dietary supplement is on the market, FDA has certain safety monitoring responsibilities. These include monitoring mandatory reporting of serious adverse events by dietary supplement firms and voluntary adverse event reporting by consumers and health care professionals. As its resources permit, FDA also reviews product labels and other product information, such as package inserts, accompanying literature, and Internet promotion.
* Dietary supplement firms must report to FDA any serious adverse events that are reported to them by consumers or health care professionals.
* Dietary supplement manufacturers do not have to get the agency's approval before producing or selling these products.
* It is not legal to market a dietary supplement product as a treatment or cure for a specific disease, or to alleviate the symptoms of a disease.
* There are limitations to FDA oversight of claims in dietary supplement labeling. For example, FDA reviews substantiation for claims as resources permit.


Are Supplements Safe?

Many dietary supplements have clean safety histories. For example, millions of Americans responsibly consume multi-vitamins and experience no ill effects.

Some dietary supplements have been shown to be beneficial for certain health conditions. For example, the use of folic acid supplements by women of childbearing age who may become pregnant reduces the risk of some birth defects.

Another example is the crystalline form of vitamin B12, which is beneficial in people over age 50 who often have a reduced ability to absorb naturally occurring vitamin B12. But further study is needed for some other dietary supplements.

Some supplements have had to be recalled because of proven or potential harmful effects. Reasons for these recalls include

* microbiological, pesticide, and heavy metal contamination
* absence of a dietary ingredient claimed to be in the product
* the presence of more or less than the amount of the dietary ingredient claimed on the label

In addition, unscrupulous manufacturers have tried to sell bogus products that should not be on the market at all.
Before taking a dietary supplement, make sure that the supplement is safe for you and appropriate for the intended purpose.


Be a Safe and Informed Consumer

* Let your health care professional advise you on sorting reliable information from questionable information.
* Contact the manufacturer for information about the product you intend to use.
* Be aware that some supplement ingredients, including nutrients and plant components, can be toxic. Also, some ingredients and products can be harmful when consumed in high amounts, when taken for a long time, or when used in combination with certain other drugs, substances, or foods.
* Do not self-diagnose any health condition. Work with health care professionals to determine how best to achieve optimal health.
* Do not substitute a dietary supplement for a prescription medicine or therapy, or for the variety of foods important to a healthful diet.
* Do not assume that the term "natural" in relation to a product ensures that the product is wholesome or safe.
* Be wary of hype and headlines. Sound health advice is generally based upon research over time, not a single study.
* Learn to spot false claims. If something sounds too good to be true, it probably is.


Report Problems

Adverse effects with dietary supplements should be reported to FDA as soon as possible. If you experience such an adverse effect, contact or see your health care professional immediately. Both of you are then encouraged to report this problem to FDA. For information on how to do this, go to www.cfsan.fda.gov/~dms/ds-rept.html.

Adverse effects can also be reported to the product's manufacturer or distributor through the address or phone number listed on the product's label. Dietary supplement firms are required to forward reports they receive about serious adverse effects to FDA within 15 days.

For a general, nonserious complaint or concern about dietary supplements, contact your local FDA District Office (www.cfsan.fda.gov/~dms/district.html).

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.


For More Information

Fortify Your Knowledge About Vitamins
http://www.fda.gov/consumer/updates/vitamins111907.html

Final Rule Promotes Safe Use of Dietary Supplements
www.fda.gov/consumer/updates/dietarysupps062207.html

Tips for the Savvy Supplement User: Making Informed Decisions
www.fda.gov/fdac/features/2002/202_supp.html

Overview of Dietary Supplements
www.cfsan.fda.gov/~dms/ds-oview.html

Food Labeling and Nutrition
www.cfsan.fda.gov/label.html



newenglandjournalofmedicine web site
http://content.nejm.org/

mental health improvement
http://news.bbc.co.uk/2/hi/health/7338644.stm

Association for Psychological Science web site
http://www.psychologicalscience.org/

hurt feelings
http://news.bbc.co.uk/2/hi/health/7587780.stm