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At your company’s weekly development status meeting with R&D, it’s communicated that the new lotion has been stabilized and there are a dozen samples for testing. All the consumer testing panelists loved it, the formula has been approved and the team is ready to go into production. But wait, the R&D representative says “It’s not ready yet. We have more to do in the laboratory.”
This can be a cause for concern and frustration for both product development and marketing groups. This article will bring some insight into what goes on behind those closed laboratory doors and the cause for the “not ready yet” moments—notably label requirements and a variety of testing possibilities/necessities that should be evaluated and conducted before full production begins.
Part of the testing program that R&D will be involved with will be determined by whether the product is classified as a cosmetic or a drug. The U.S. Food and Drug Administration (FDA) classifies a drug as an “article 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.” On the other hand, a cosmetic is described as an “article 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.”
Thus drug is defined as having an effect, while cosmetics are classified as beautifying. In the world of personal care products, an antiperspirant is a drug (has an effect on the body-reduced perspiration) while a deodorant is a cosmetic—beautifying (reducing odor) rather than an effect on the body. A shampoo is a cosmetic while an anti-dandruff shampoo is a drug (has an effect on the body). Those items that are FDA-classified as drugs but do not require a prescription are called over-the-counter (OTC ) drugs. OTC categories that impact personal care products include anti-acne, antiperspirant, antibacterial, anti-fungal, anti-dandruff, diaper rash, skin protectant and sunscreen, among others. Interestingly, the FDA does not recognize “cosmeceuticals,” which straddle both definitions. [Per the FDA website: “A product can be a drug, a cosmetic, or a combination of both, but the term ‘cosmeceutical’ has no meaning under the law.”]
A cosmetic must have an ingredient list that has the accepted ingredient names listed in decreasing quantitative order. Those items at 1% formula concentration or below may be placed in random order. To retail in the EU, if certain allergens are present above a specified amount, they must be listed. [Please read the Chemical Reaction column on Page 58 for further information.] The term “Fragrance/Parfum” is used and placed in the proper descending order of predominance. The composition of the fragrance need not be disclosed. A drug, on the other hand, has to have the active ingredient and percentage in the formula listed separately from the inactives. These are included in a required “Drug Facts” framed box which also contains “Warnings,” Directions for Use” and other required information.