Claudia A. Lewis, co-chair of Venable LLP’s FDA Group, recently spoke at the 9th Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York. She discussed the latest developments in OTC Monograph Reform including the FDA’s Deemed Final Orders (DFO), and how this impacts the cosmetics and personal care industries. Lewis counsels clients on matters involving FDA regulation, labeling and marketing of foods, over-the-counter drugs, medical devices and other products.

After the conference, Happi checked in with Lewis about what should be on a beauty brand’s radar right now. She also shared insight the need for nuance in marketing and other issues impacting cosmetics and skincare.

HAPPI: Are there any developments regarding the OTC Monograph Reform including the FDA’s Deemed Final Orders that beauty and personal care companies must have on their radar right now? What are they and why are they a concern—or should be a concern—for beauty and personal care brands?
Lewis: Yes, there are many products in the market to address skin lightening and discoloration.  It is important to note that it appears that the Monograph Reform effectively makes it illegal to sell skin lightening products, except for the FDA-approved drug Tri-Luma.  FDA is prioritizing enforcement in this space and has issued numerous Warning Letters to companies marketing skin lightening products in recent months.  Another issue that I am watching is sunscreen.  Companies that sell sunscreen or companies that are thinking of entering the sunscreen market should be aware that sunscreen is considered a drug and must comply with FDA’s Deemed Final Order (DFO) on sunscreen.  Importantly, FDA is preparing to amend the sunscreen DFO, and while we do not know exactly what that amendment will look like or when it will become final, there is a possibility that FDA will severely limit the types of active ingredients that can be used in sunscreen.

HAPPI: Let’s talk cosmetic claims vs. drug claims. Many experts say the lines here are often blurred. Where is this issue having the most impact now? What about future issues that could arise from this?  
Lewis: It is true that cosmetic and drug claims can become blurred.  Especially since there are a number of products that fit into both categories.  Cosmetic claims can only convey that a product “cleans[es], beautify[ies], promot[es] attractiveness, or alter[s] the appearance.”  If a claim goes beyond that and conveys that the product prevents or treats a health condition, such as acne, or affects the structure or function of the human body, FDA will likely take the position that it is a drug rather than a cosmetic.  This rule can require nuance when marketing products to address hair loss, certain anti-aging claims and transdermal products.

HAPPI: Does the above tie the hands of companies that are pushing their R&D and science to provide much more efficacious skin care products?
Lewis: It certainly can.  Cosmetic companies understandably want to offer products that actually solve skin problems, not just mask them.  And the market demands cosmetics that are effective.  But there is a fine line that must be met to avoid the product being deemed a drug.  A good rule of thumb is superficial and temporary impact rather than formulations that are intended to have a systemic effect.  For the later, FDA would likely consider that product a drug.

HAPPI: Do you have guidance for indie brands that may not have deep legal expertise or access to experts when trying to navigate the complex world of FDA regulation, including cosmetic v. drug claims?
Lewis: The most important thing to remember when it comes to FDA regulation, even where a claim may be true and supported by adequate science, it still may not be permitted under FDA rules. If legal counsel is not in your immediate budget, attend seminars and carefully review FDA’s website.  It has some very good, although basic, information on what types of claims are permitted for cosmetic products. 


About The Expert: With a deep knowledge of dietary supplement labeling regulations, Claudia A. Lewis represents scientists, physicians, nutritionists, healthcare associations and citizen groups. She has also aided international clients in establishing a US market for their products. She has prepared and presented constitutional and administrative law cases before the FDA, Federal Trade Commission (FTC), Department of Justice (DOJ), Bureau of Land Management (BLM), and Environmental Protection Agency (EPA). She also counsels on FTC regulations governing advertising on the internet, on television, in print media, and on the radio; FTC telemarketing regulations; US Department of Agriculture (USDA) regulations governing pesticides. Lewis can be reached at [email protected]