Regulation of Probiotics in the USA: Cosmetics

Guest BloggerIPA Counsel Corner

Regulation of Probiotics in the USA

by Ivan Wasserman, IPA Counsel

Part 3: Cosmetics

Cosmetic products are an exciting new category for probiotic-related ingredients. It may seem that cosmetics are less regulated than other FDA regulated product categories, such as dietary supplements and foods (which we discussed in previous articles).  However, despite the fact that the name is only the “Food and Drug Administration,” FDA does in fact regulate cosmetic products under the Federal Food Drug and Cosmetic Act.  Like other products regulated by FDA, it is not legal to sell adulterated or misbranded cosmetics.   There are also specific regulations regarding the labeling and safety of cosmetic products.

Cosmetics are defined as “(1) articles 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, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap” (U.S.C. § 321(i)).

So, cosmetics must be “intended” for “cleansing, beautifying, promoting attractiveness, or altering the appearance.”   This sets the guideposts for what types of claims cosmetic products can make.  FDA has not provided specific guidance on constructing proper cosmetic claims, but has provided a plethora of detail of what is not a proper cosmetic claim.  Primarily, unlike dietary supplement and food products, cosmetics cannot make “structure/function” claims, such as immune or digestive system support.  Also, they are generally limited to external, temporary effects.  Any claim that states or implies that a cosmetic has a systemic or lasting effect could cause FDA to take enforcement action

With respect to ingredients and safety, FDA generally does not approve or otherwise review the safety of ingredients in cosmetic products or finished products. There is no cosmetic equivalent to the ingredient safety standards applicable to food and dietary supplement products, i.e. GRAS certifications, food additive petitions, or new dietary ingredient notifications.  While there are a few ingredients that are prohibited, and color additives are subject to approval, in general the manufacturer must determine that a cosmetic product is safe for its intended use prior to marketing.