Feds Cracking Down on Cosmetics

The cosmetic and skin care industry is a multibillion-dollar business. Consumers often spend money on top dollar products seeking the fountain of youth and the latest makeup trends.

The U.S. Food and Drug Administration has authority over cosmetics and has a warning for consumers shopping for them.

“What they may be buying may not be proven to do what you think it’s going to do,” said Dr. Linda Katz, the director of cosmetics and colors at the FDA.

“There are plenty of products out there that may or may not have labeling that’s appropriate for the type of category it should fall into,” she said.

This is how the law defines cosmetics:

The Federal Food, Drug and Cosmetic Act defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body ... for cleansing, beautifying, promoting attractiveness, or altering the appearance." Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors and deodorants, as well as any substance intended for use as a component of a cosmetic product.

This is how the law defines a drug:

The Federal Food, Drug and Cosmetic Act defines drugs, in part, by their intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals."

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So far this year, the FDA has issued five warning letters to companies accusing them of using “drug claims” for products marketed as cosmetics:

Skin Authority LLC

Company response: “Designed to protect the consumer, these regulations are vast and can impact every company that markets beauty products. Speaking from firsthand experience, it’s not only the ingredients or formulas of the product, but also the wording used in communicating on websites to the consumer, which can be considered ‘implied claims,’ that determine intended use of the product.

“In our case, Skin Authority proactively educated our marketing and product teams on the guidelines and initiated a thorough review of all existing marketing materials/website language and established a QA process to monitor new materials being produced.”

Moy-Fincher Medical Group

Company response: Did not respond to our request.

Strivectin Operating Company

Company response: Did not respond to our request.

Loreal USA

Company response: Did not respond to our request

Chaga Mountain, Inc.

Company response: “We were inspected by FDA late September, early October 2014. We immediately responded via certified mail to the FDA in regards to what was noted in the inspection with manufacturing records and batch records. We were certain we had satisfied and met compliance with FDA until we received the warning letter the week of Jan. 20, 2015.

“At this time we immediately removed scientific publications from Sloan Ketter and other credible scientific entities from our website, even though our competitors continue to have the same or similar publications on their websites. We were then notified that our customers’ testimonials were ‘making claims,’ as well. Even though I believe without a doubt that being forced to remove the testimonials is a tremendous infringement on our first amendment rights, for at the very least our customers’ First Amendment rights. We removed our testimonials.

“Since this time we have received another letter dated April 9, 2015, with a follow up of the warning letter and what remains to be fixed in order to be in compliance. Again we immediately responded to the letter, and have tried diligently to satisfy FDA and their compliance issues with our small family business….”

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