By: Ronie Schmelz
Counsel at Tucker Ellis LLP

Despite Deregulation in 2017, Cosmetic Companies Remain FDA Focus

President Donald Trump has made deregulation a cornerstone of his administration, demanding that for every new regulation proposed, regulatory agencies identify two regulations for elimination; however, this directive has not impeded regulatory oversight at the U.S. Food and Drug Administration (FDA).  Although the number of FDA Warning Letters sent to cosmetic, skin care, and other personal care companies has decreased significantly under the new administration, these companies still remain a focus for FDA.  While the future is impossible to predict, the following summary of regulatory activity in 2017 provides a good guidepost for the types of claims to avoid so that your company does not become the recipient of an FDA Warning Letter.

prevent your company from receiving a FDA Warning Letter

In 2016, FDA issued over 35 Warning Letters to cosmetic, skin care, and personal care companies.  Less than half that number – twelve letters, to be exact – was issued in 2017.  Recipients of these Warning Letters were companies that make what FDA has long considered improper drug claims about their cosmetic products.  It should come as no surprise that making product claims like those listed below is likely to illicit regulatory scrutiny:

  • Helps stimulate collagen production
  • Helps combat acne, rosacea, and eczema
  • Repairs skin damage
  • Promotes cellular generation
  • Improves blood circulation and natural skin regeneration
  • Has anti-inflammatory and antibacterial qualities

According to FDA, each of the foregoing claims convert what might otherwise be considered a cosmetic product into an unapproved drug intended for use in the cure, mitigation, treatment, or prevention of disease and/or a product that is intended to affect the structure or function of the human body.  FDA also challenged claims that one might not consider to be obvious drug claims, including:

  • Lighten and even skin tone, age spots, and freckles
  • Relax the body from throbbing head to aching toe
  • Soothe itchy, dry, and flaking skin

cosmetic INGREDIENT claims & fda

By and large, the companies that made these borderline claims also made obvious drug claims, which was likely the impetus for FDA’s action.  It remains to be seen whether FDA will pursue companies that make borderline cosmetic/drug claims but otherwise refrain from making what are obvious drug claims.

As more companies look for ways to distinguish their products in the competitive cosmetic marketplace, they have begun to focus their claims on product ingredients.  Particularly in the skin care space, companies emphasize the well-known benefits of certain ingredients, thereby implying the products themselves will deliver the same benefits.  This practice was met with increased scrutiny by FDA in 2017.  Here is a sample of such ingredient claims, all of which were subjects of Warning Letters:

  • Lavender has been used as a remedy for a range of ailments from insomnia and anxiety to depression and fatigue. Lavender has many other health benefits: antibacterial, antidepressant, anti-inflammatory, antispasmodic, anti-toxic, antiviral.  Studies have shown that lavender… reduces irritability, apprehension, stress, nervous tension, insomnia, and nightmares.
  • Contains green tea to promote cellular regeneration.
  • Coconut oil has natural antibacterial, anti-fungal, and antimicrobial properties which provide a protective layer on your skin and can help facilitate healing of skin conditions such as rashes, acne, and other infections.
  • Chamomile flowers essential oil has anti-inflammatory properties and is used to encourage digestion and boost the immune system.
  • Shea butter is effective in improving or treating skin inflammation and irritation such as burns and acne, dark spots, eczema, and psoriasis.
  • Vitamin C helps protect against damaging UVA/UVB rays and stimulates collagen production.
  • Peppermint oil is used to relieve skin irritation, itchiness, and redness where inflammation is present.
  • Tea tree oil has anti-microbial, anti-viral, and anti-fungal properties which help with the treatment of acne, dandruff, rashes, sunburns, and other skin conditions.
  • Research has shown aloe vera’s unique ability to regenerate cellular membranes and boost the product of cells responsible for collagen production.

In addition to reviewing product packaging and brochures, company websites, and ingredient and product claims, FDA continued to scrutinize company websites for consumer reviews heralding the drug-like benefits of products.  FDA considers any statements made on a company website to be advertisements for the company’s products, even if the statements are in the form of third-party consumer reviews.  Here are some reviews challenged last year as constituting illegal drug claims:

  • “I have osteoarthritis and when my knees or feet are aching, I just rub the product on and it instantly takes the pain away.”
  • “I suffer from TMJ, a muscle disorder, and I would be in debilitating pain if it wasn’t for this cooling rub.”
  • “The product soothed my sunburn and my psoriasis.”

As the foregoing confirms, the administration’s goal of reducing the number of regulations does not mean that federal agencies will not continue to use existing regulations to challenge product claims.  Companies should vigilantly review their product claims and scrub their websites of claims that can unwittingly convert their cosmetic products into an unapproved drugs, and in turn attract the attention of FDA.

About the Author:
Ronie Schmelz regularly counsels clients to ensure compliance with regulations enforced by the Food and Drug Administration (FDA), Federal Trade Commission (FTC), and other regulatory agencies; California Proposition 65; and advertising, labeling, and claim substantiation. She also represents clients in regulatory and legal proceedings, including consumer class actions.

Find out more about Ronnie Schmelz here.


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