Today, I’ve asked Allyson Hein to share her thoughts on the new reality of Consumer Products companies facing increased regulatory scrutiny from FDA. Allyson has over 25 years of experience as a quality professional in FDA regulated industries and now serves Consumer Products and Life Sciences companies as a senior consultant with Clarkston.

Consumer Products companies, are you asking yourself why FDA is knocking on your door claiming they are visiting for an Over the Counter (OTC) drug inspection? And, are you still wondering who or what CDER is?

As Baby Boomers age, these consumers want anti-wrinkling solutions and brightening creams to combat the signs of aging. They want whiter teeth, anti-dandruff shampoo and foods that enhance athletic performance or lower cholesterol. Over time, your Health and Beauty company has expanded portfolios to meet the changing demands of these customers. Doing this makes great business sense and meets customer needs through innovative products. However, meeting your customers’ needs will lead to the FDA looking at you differently. From the FDA’s perspective, you may have crossed the line into Over the Counter (OTC) drugs, and now different laws and regulations apply to your expanded product portfolio.

FDA regulates Health and Beauty Products. Their regulatory authority in this area goes back to the Pure Food and Drug Act of 1906 and the Food Drug and Cosmetic Act of 1938. The Pure Food and Drug Act was strengthened in 1938 after journalists, consumer protection organizations, and federal regulators mounted a campaign for stronger regulatory authority by publicizing a list of injurious products that had been ruled permissible under the 1906 law, including radioactive beverages and the mascara Lash Lure which caused blindness. Just like in 1938, FDA wants to make sure injurious products don’t make it onto the market, and therefore drugs are regulated more stringently than cosmetics.

Whether a product is a cosmetic or a drug under the law is determined by a product’s intended use. The Federal Food, Drug, and Cosmetic Act (FD&C 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” [FD&C Act, sec. 201(i)].

The FD&C 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” [FD&C Act, sec. 201(g)(1)].

Your company could have products classified as both a drug and cosmetic such as an aromatherapy fragrance promoted to help you sleep and increase your attractiveness by giving you a pleasing smell. This means your interactions with FDA will change and your company must meet their OTC expectations.

FDA is paying closer attention to companies that manufacture cosmetics that contain medicinal attributes. In consideration of this, Health and Beauty companies with such products – at least from a validation and quality systems perspective – will be best served to consider themselves drug companies. This means from R&D processes, to computer systems, to manufacturing processes, every aspect of the business must be in compliance with FDA OTC regulations. FDA’s Center for Drug Evaluation and Research (CDER) is the office within the FDA responsible for the regulations of OTC drugs. Their website contains helpful information that will assist you with understanding their expectations for OTC drug companies. The transformation from cosmetic to OTC is challenging.

We would enjoy a dialogue with you on some of the following topics:

• What challenges have you encountered in becoming OTC complaint?
• Are you a consumer products company who recently experienced an FDA inspection and the agency considered you a drug company?
• How are your marketing, R&D and legal teams working together to ensure your marketing claims are accurately representing your products and follow the right set of FDA requirements for product labeling?
• Where does staying compliant with different GMP and facility registration requirements present new challenges?
• Does FDA inspection scheme strategy figure into your manufacturing location decisions or organizational structure?

Read the next blog in this series, Quality Systems Validation – Does it Apply to Consumer Products?