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There is often bit of a grey area between cosmetics and drugs, which can make marketing your products a bit of a challenge. Instead of assuming the item falls into one category or another, you must thoroughly investigate until you’re certain — or risk breaking the law.

Cosmetic Items vs. Drugs vs. Both

Under the terms of the Federal Food, Drug, and Cosmetic Act (FD&C Act), cosmetics are defined 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)]. In addition to common cosmetic items, such as lipsticks, nail polishes, shampoos, deodorants and perfumes, this includes substances designed for use as part of a cosmetic item.

On the other end of the spectrum, the FD&C Act defines drugs 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)].

Many products clearly fall into one category or another, but some may meet the criteria for both cosmetics and drugs if they have two markedly different intended uses. For example, dual purpose products such as makeup with a sun protection factor and antidandruff shampoo are technically in both groups, so they must comply with the requirements of each.

Determining Intended Use

Since the intended use of your product determines which category it falls into, getting it right is essential. Three ways to decide if your item is a cosmetic, drug or both includes:

  • Advertising Claims: Consider the message you’re sending with product labeling, advertising, and other promotional efforts.
  • Consumer Perception: Think about the reason the customer decides to make a purchase and what they hope to gain from the product.
  • Ingredients: Carefully analyze any popular ingredients used to make the product that drive people to buy it.

Come back soon for the fourth and final portion of our four-part consumer safety series, “What is a Cosmeticeutical?”.

If you expect your cosmetic company to reach its goals, you need to have all the right people in all the right places. Whether you’re searching for a junior professional or a senior executive to lead your organization, Momentum Search Consultants is here to assist every step of the way. Contact us today to discuss a partnership!

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