The Hidden Compliance Risk of Selling Cosmeceuticals in Pennsylvania
The cosmeceuticals market is swiftly expanding as more people focus on skin and hair health. In Pennsylvania, cosmeceutical retailers must register with the Pennsylvania Department of Health (PA DOH) as a drug retailer or otherwise face exposure to significant noncompliance penalties.
Cosmeceuticals are cosmetics that offer medicinal benefits through bioactive ingredients: reducing aging and inflammation in the skin; protecting the skin from UV rays; preventing skin oxidation; brightening and lightening the skin; improving skin and hair texture; and enhancing hair growth. Essentially, cosmeceuticals blend the appearance and application of cosmetics with the function and benefit of pharmaceuticals. Although the term has been common since the 1980s, the U.S. Food and Drug Administration (FDA) has refused to recognize cosmeceuticals as a distinct product category, choosing to treat them as drugs, cosmetics or both, potentially leading to regulatory compliance issues for cosmeceutical retailers.
Similarly, the PA DOH treats cosmeceuticals as drugs, cosmetics or both, depending on whether the specific cosmeceutical meets the definition of a drug. In the Controlled Substance, Drug, Device and Cosmetic Act, the PA DOH defines cosmetics as “substances intended to be rubbed, poured, sprinkled or sprayed on, introduced into or otherwise applied to the human body . . . or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance,” excluding soap. Further, the PA DOH defines drugs as “substances intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man . . . and [] substances (other than food) intended to affect the structure or any function of the human body.” Thus, any cosmeceutical that is applied to clean, beautify, increase attractiveness or otherwise alter a person’s appearance, and that cures, mitigates, treats or prevents disease in or otherwise alters the structure or function of the human body, is both a cosmetic and a drug in Pennsylvania. For example, a cosmeceutical foundation that includes peptides would be considered both a cosmetic and a drug. It would be a cosmetic because foundation is a type of makeup that is applied to beautify and increase attractiveness. It would also be a drug because peptides signal the body to generate more collagen and elastin to reduce lines and wrinkles in the skin, altering the structure of the human body.
This distinction between pure cosmetics and cosmetics that also meet the definition of a drug is important because anyone who is retailing a drug in Pennsylvania must register with the PA DOH. This means that those selling cosmeceuticals must generally register as a drug retailer in Pennsylvania. In effect, a retailer that is selling a foundation containing peptides must register as a drug retailer with the PA DOH. While many businesses selling cosmeceuticals are likely already registered as drug retailers, such as pharmacies, grocery stores or big-box retailers, many small boutiques or salons may not be properly registered as drug retailers to sell cosmeceuticals to their customers.
Although the registration requirement is clear, the penalties for noncompliance cannot be described in the same light. While there are harsh penalties for failing to register as a drug manufacturer or distributor, including potential fines and jail time, there are no statutory or codified penalties established for failing to register as a drug retailer. However, drug retailers face harsh penalties, including potential fines and jail time, for not following sanitation, material, equipment and supply standards established by the Pennsylvania secretary of health. The statutes and regulations have not clearly established any of these standards for drug retailers. Even though the exact penalties are unclear, it is a best practice for any organization selling cosmeceuticals to proactively register as a drug retailer to avoid any potential legal consequences for noncompliance.
