Report Bad Products To FDA

You break out in red rashes after using a sunscreen. Your daughter gets itchy and blotchy after applying makeup. That expensive hair relaxer your wife loves burned her scalp.

Who do you complain to … the store that sold the product to you, the manufacturer who made the item, or do you and your family suffer in silence?

If you’ve had a negative reaction to a beauty, personal hygiene, or makeup product, the U.S. Food and Drug Administration wants to know your story.

Why? FDA action could save others from suffering the same fate.

Every day Americans depend upon personal care products. Most are safe, but some cause problems, and that’s when FDA gets involved.

“Even though these products are widely used, most don’t require FDA approval before they’re sold in stores, salons, and at makeup counters,” says Dr. Linda Katz, director of the agency’s Office of Cosmetics and Colors.

“So, consumers are one of FDA’s most important resources when it comes to identifying problems.”

Defining Cosmetics

The federal Food, Drug, and Cosmetic Act defines “cosmetics” as products intended to be applied to the body “for cleansing, beautifying, promoting attractiveness, or altering the appearance.”

But the legal definition includes items that most Americans might not ordinarily think of as cosmetics, including:

•Face and body cleansers
•Deodorants
•Moisturizers and other skin lotions and creams
•Baby lotions and oils
•Hair care products, dyes, conditioners, straighteners, perms
•Makeup
•Hair removal creams
•Nail polishes
•Shaving products
•Perfumes and colognes
•Face paints and temporary tattoos
•Permanent tattoos and permanent makeup

What To Report

Katz says consumers should contact FDA if they experience a rash, hair loss, infection, or other problem — even if they didn’t follow product directions.

FDA also wants to know if a product has a bad smell or unusual color — which could signal contamination — or if the item’s label is incomplete or inaccurate.

If you have any concerns about a cosmetic, contact MedWatch, FDA’s problem-reporting program, on the Web or at (800) 332-1088; or contact the consumer complaint coordinator in your area.

When you contact FDA, include the following information in your report:

•Name and contact information for the person who had the reaction;
•Age, gender, and ethnicity of the product’s user;
•Name of the product and manufacturer;
•Description of the reaction—and treatment, if any;
•Healthcare provider’s name and contact information, if medical attention was provided;
•When and where the product was purchased.

FDA scientist Wendy Good advises to give the age, gender, and ethnicity of the person who had the reaction.

Good, who analyzes reports about problems with cosmetics, says that information is important because it can help scientists spot trends.

When a consumer report is received, FDA enters the information into a database of negative reactions. Experts then look for reports related to the same product or similar ones.

FDA scientists will use the information to determine if the product has a history of problems and represents a public health concern that needs to be addressed.

If you file a consumer report, your identity will remain confidential, according to the FDA.

“Cosmetics are usually safe, but when they aren't, consumer reporting is essential so FDA can take action when appropriate,” Katz says.

Those actions could, depending upon the product and the problem, range from issuing a consumer safety advisory to taking legal action.

Safety Comes First

While WMB generally believes in smaller government and limited controls, we see consumers benefiting from interaction with the FDA.

Privacy concerns should take a back seat when the public’s safety is put at risk.

The FDA serves the public interest in a watchdog role. However, it needs good information to do its job and protect consumers.

As always, WMB advocates consumer activism. Nothing will be achieved by our silence.

Ken Cocuzzo

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Cosmetics: More Than Skin Deep

The worldwide cosmetics industry is a multi-billion market and growing. There are few women, especially in the Western World, who don’t use cosmetics.

Whatever is applied to your skin is absorbed to some degree, so what's in the cosmetics you use should be of concern to you personally and globally.

Some consumers may not consider that discarded cosmetics either end up in a landfill or down the drain, not to mention the many millions of plastic jars, tubes and other packaging materials discarded into our landfills.

Beyond the environmental impact is the market certification and approval process. Many new products are tested on various animals and can have horrific results.

One cosmetic gaining attention lately is nail polish. Many brands use dibutyl phthalate, a chemical that has been officially linked to cancer in animals.

Other examples of chemicals used in cosmetics include acrylamide formaldehyde and ethylene oxide. Both of these ingredients are listed by the U.S. Environmental Protection Agency as known carcinogens. Products of most concern include:

• Eye Shadow
• Facial Powder
• Hair Color and Bleach
• Nail Polish
• Anti-Wrinkle Creams

Many of these products include toxins such as mercury, lead acetate, formaldehyde, ethyl acrylate, tolulene, coal tar, and petroleum distillates. Even lipstick is a concern because it is made from synthetic oils, man-made dyes and pigments, and petroleum-based waxes.

The point is it really pays to notice the chemicals used in various cosmetic products and what the long-term effects of those ingredients are on you and the environment. Whenever it’s possible, consumers need to tap earth-friendly brands even if they cost considerably more than traditional products.

There are several brands worth considering. One example is from Mode Cosmetics ; their products are typically less than $3 and manufactured in the United States. Another brand worth considering is Suncoat Products. This company provides water-based formulations for nail polish, for example, and it has no odor.

Nano particles used in cosmetics and other health care products also are of concern for consumers. Science Daily last May reported nano particles added to cosmetics and other personal care products may be harmful to humans and the environment.

An article by Dr. Cyndee Gruden and Olga Biebesheimer reported nano titanium dioxide particles, as well as other nano pigments, commonly used in cosmetics, sunscreens, and other personal hygiene products are rinsed down the drain when people take showers or bathe.

These chemicals typically end up in municipal sewage treatment plants. From there, the particles are found in lakes and rivers or other water sources, where microorganisms serve an essential role in maintaining a healthy environment. The problem is these particles are so small that their effects are not well understood.

Gruden studied the survival rate of Escherichia Coli (E. Coli) exposed to various amounts of nano titanium dioxide. The study results found there were large reductions in survival in test samples exposed to small concentrations for less than an hour.

The results beg the question: What are the implications to human life and our ecosystem?

There’s a lot of debate about nano particle toxicity. Some scientists believe nano particles can aggregate together and bind into silt or other organic matter and greatly reduce the risk of toxicity. But, for now, scientists simply are not sure.

The public is responsible for understanding risks associated with consumer products such as cosmetics. It’s up to the scientists developing cosmetics and related products to study the effects of the ingredients and report the findings to the public.

Bottom line: Read the label, it may save your life.

Note: This post comes to We Mean Business from TechMan, a contributor who writes about trends involving various industries.