Posted by Stephanie Bouzounis, Senior Communications Specialist
Daily consumers use and consume products that have the potential to harm or enhance their health. Medications, food, and medical devices are all regulated by the Food and Drug Administration (FDA). Cosmetics, like these products, are also regulated. Cosmetics, unlike these products, do not have as much oversight. Surprised?
The Federal Food, Drug, and Cosmetic Act (FD&C) was passed in 1938 – 80 years ago. There are ten chapters to this law. Chapters one and two focus on short title and definitions, which define food, drug, medical device, food additives, and dietary supplements. The third chapter covers prohibited acts and penalties and it goes into detail on civil and criminal statutes. Chapter four creates the definition and standards for food. Chapter five defines drugs and devices, including general provisions, drugs for rare diseases, and even animal drugs. Chapter six deals with cosmetics. Cosmetics are defined as articles intended to be rubbed, poured, sprinkled, or sprayed on or into, or otherwise applied to the human body, with the intention to cleanse, beautify, promote attractiveness, or alter appearance. The other chapters cover general authority of the FDA, imports and exports, tobacco products, and other miscellaneous items.
Cosmetic products and their ingredients, excluding color additives, do not require FDA approval before going on the market. For comparison, if a medical device manufacturer created a device, technical documentation and clinical trial data would have to be submitted prior to approval. While cosmetic products do not cause as much concern for safety as a drug or implantable medical device, there are still problems that may potentially arise. WEN hair care is a brand of cleansing conditioner shampoo that was advertised via infomercial. In 2014-2015, a class action lawsuit was brought against the company by over 200 women across 40 states. The claim was that Wen products caused severe hair loss and hair damage. On July 7, 2016, 127 consumer complaints were registered with the FDA against the brand versus 21,000 complaints registered with the company – which they were not required to report. This prompted the FDA to investigate the claims, where they totaled 1,386 more complaints. Eventually, WEN settled the $26 million lawsuit, and as of January 2018, settlement checks were being mailed out. Indie beauty company Lime Crime received a warning letter from the FDA concerning an ingredient, ferric ferrocyanide – a color additive – which is considered unsafe in the meaning of section 721(a) of 21 CFR. If the ingredient didn’t cause the reaction, then that means the product was mislabeled. The FDA only issued the letter after receiving customer complaints.
While the burden is primarily on the consumer to be vigilant in the case of personal care and cosmetic products, new legislation has been introduced in an attempt to change that. Senators Dianne Feinstein and Susan Collins introduced the Personal Care Products Safety Act in 2015 which would require cosmetic companies to register their facilities with the FDA, submit cosmetic ingredient statements, and pay a facility registration fee. The FDA would be required to develop and implement cosmetic manufacturing standards, be allowed to inspect the company’s safety records, recall a cosmetic, and encourage cosmetic safety testing. In 2016, Representatives Frank Pallone and Leonard Lance released a discussion draft of a sister bill in the House of Representatives. Currently, the FDA has a voluntary registration program.
Have a question regarding regulatory affairs that was not answered here? Please give us a call at (248) 987-4497 or email info@emmainternational.com.
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