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

If you enjoyed this post, please consider subscribing for FREE (link in right sidebar) and sharing it on Facebook, Twitter, or your favorite social network. Thank you!

Food Safety Deputies Needed

Ever wonder about the safety of the food served at your local diner or favorite restaurant? Ever worry about the products you buy at the supermarket, or the food prepared at your child’s school?

Chances are any or all of the above has left you concerned, even fearful, since there have been growing reports in recent years of food-borne illnesses from tainted produce, consumer items and prepared meals.

But consumers have allies in the U.S. Food and Drug Administration and more than 3,000 state, local, territorial, and tribal agencies which work together to help keep retail food safe throughout America.

The agencies regulate more than 1 million retail food establishments, ranging from restaurants and grocery stores, to caterers and coffee shops, school and hospital cafeterias, and vending machines and mobile food trucks. They also regulate food facilities at temporary events such as state and county fairs.


State, local, territorial, and tribal agencies have the main responsibility for inspecting and licensing food establishments and enforcing regulations. Working closely with these agencies is the National Retail Food Team, which includes FDA food safety experts, trainers, and retail food specialists.

U.S. System of Safeguards

The FDA Food Code is a system of safeguards for retail food establishments to use to ensure consumers are served or sold food that is safe to eat. It includes standards for cooking times and temperatures, refrigeration temperatures, and storage requirements for many kinds of foods.

“All the rules we tell the public to follow — washing hands and food preparation surfaces, separating foods to prevent cross-contamination, cooking to proper temperatures, and refrigerating promptly — are in the code,” says Kevin Smith, director of FDA’s Retail Food and Cooperative Programs Coordination Staff in College Park, Md.

FDA develops, updates, and promotes the Food Code as a model for state and local agencies to adopt and use in regulating retail food establishments in their jurisdictions.

Guidance, Training and Enforcement

While state and local agencies have the authority to pass or fail a restaurant after inspection, remove unsafe products from store shelves, and arrest and fine violators, FDA provides the guidance and training they need to protect food in their jurisdictions.

“Training is a big part of the retail food specialist’s job,” says Capt. Cynthia Kunkel, an FDA regional food specialist in Lenexa, Kan. FDA’s two dozen retail food specialists work within five geographic regions covering the entire United States, with each specialist responsible for a group of states in that region.

A key part of the process is a combination of training and “standardization,” a field exercise involving six to eight inspections with a standard and a candidate. If the candidate successfully completes the exercise, he or she becomes certified as an FDA Standardized Food Safety Inspection Officer.

At FDA’s Center for Food Safety and Applied Nutrition in College Park, Md., a standardizing official tests agency retail food specialists. Once qualified, these specialists return home to standardize state officials, who, in turn, standardize county and local inspectors.

Any retail establishment with a kitchen may be subject to an inspection by a Standardized Food Safety Inspection Officer. FDA retail food specialist Larry Edwards in Falls Church, Va., standardized the officer who works in the U.S. Capitol in Washington, inspecting the many kitchens which serve Congress, its employees, and the millions of people who visit the federal building.

“Whether the kitchens serve pizza, fast foods, or sit-down dinners for Congress — they are all inspected by people standardized by FDA,” says Edwards.

In the summer of 2009, FDA collaborated with the Illinois Department of Public Health to curb an outbreak of hepatitis A. This liver-damaging viral infection can be spread by consuming food or drinks handled by an infected person.


In this case, two infected employees at a fast food restaurant in Milan, Ill., handled food served to the public. The infection spread to 34 other people, including 14 who needed to be hospitalized.

Jayne Nosari, a food program manager in the Illinois Department of Public Health, says FDA helped guide the state on hepatitis A control measures during the outbreak and gave provided a six-step disinfection process designed for hepatitis A virus cleaning and sanitizing.

The state and county health departments then worked together to carry out the disinfection, allowing the restaurant to reopen after a three-day closure.

Emerging Problems Addressed

FDA’s food safety experts identify research needed to address emerging food safety concerns, and often work cooperatively with other federal agencies to conduct the research.

For example, FDA is working with the U.S. Department of Agriculture to study practices for cooling foods in school cafeterias and to develop educational materials that highlight the most effective methods. “Without rapid cooling, bacteria can grow in foods and cause food-borne illness,” says FDA’s Smith.

Food Deputies Needed

We at WMB believe food safety requires a partnership between the FDA, agencies and the public. While the FDA handles the training and enforcement aspects, it’s up to the public as educated consumers to serve as watchdogs by paying attention to details, especially when it comes to lawbreakers.

When you visit a diner, for example, see how the staff prepares and serves food, especially if the kitchen area is open to public view. Do they wear rubber gloves when handling food… are their uniforms clean … do they keep their long hair contained?

At the grocery store, check the expiration dates on everything, from canned items to meat products. If a can is dented or package appears a bit off, do not purchase it. As a courtesy to others, report any out of date or damaged stock to management.

As for schools, ask your kids about the food and get clued in to what the cafeteria routine is on a daily basis. While districts have standards for food workers, ask if random inspections are performed. If so, ask to see written reports – public tax dollars for schools means you have to right to review this information.

Finally, when it comes to food safety, WMB believes the best defense is a good offense. Don’t leave things to chance: Be an advocate for yourself and others!

As for me, I practice what I preach at writenowworks.com. Please share this post with family, friends and colleagues.