FDA approved: A misleading claim?
In Practice
Steven R. Feldman, MD, PhD, is in the department of dermatology at Wake Forest School of Medicine in Winston-Salem, North Carolina.
By Victoria Houghton, assistant managing editor, March 1, 2018
Dermatology World talks with Steven R. Feldman, MD, PhD, Lindsay Strowd, MD, and Elise Martin, BA, about the term 'FDA approved' and how some companies' use of the term for over-the-counter products may be somewhat misleading.
Dermatology World: What is required for a prescription product to be marketed as FDA-approved’?
Dr. Feldman, Dr. Strowd, and Martin: The FDA approves both prescription and OTC products. Prescription products require animal pharmacology and toxicology studies, review of manufacturing information, trial protocols, clinical trials, and review of the proposed drug name, label, and packaging.
Dermatology World: How does an over-the-counter (OTC) product become FDA approved’?
Dr. Feldman, Dr. Strowd, and Martin: OTC products can be FDA-approved in two ways: through the new drug application (NDA) process described above or under an OTC monograph. OTC monographs consist of acceptable ingredients, doses, formulations, and labeling for certain drug categories. If an OTC product fulfills these guidelines, it is automatically deemed safe and effective for that drug category and can be marketed without undergoing the NDA process. For example, if a product contains 325 mg of aspirin, that product can be marketed as a pain reliever.
Dermatology World: Can you provide an example of how the FDA approved’ designation for an OTC product was technically accurate, yet misleading?
Dr. Feldman, Dr. Strowd, and Martin: One newly advertised OTC topical treatment for eczema, Atopis, claims FDA approval — indeed, this approval was announced in the Dec. 6 issue of Dermatology World Weekly — yet no information about the product exists on the FDA website. The company advertises its ingredient myriphytase extract as its key ingredient; however, the inclusion of the ingredient glycerin, which falls under the OTC monograph for eczema, allowed FDA approval of the product. As no information about the product can be found in the FDA registry, FDA approval was likely gained under an OTC skin protectant drug product’ category completely unrelated to the myriphytase extract.
We did find one company-sponsored open label study of the cream, published in the International Journal of Phytocosmetics and Natural Ingredients (not a Medline-referenced journal), comprised of 20 subjects with mild-to-moderate eczema. The study reported 8% of patients developed severe eczema after two weeks of treatment; the mean improvement in quality of life for the study population (assessed with the Dermatology Life Quality Index) did not achieve a clinically important difference.
The advertisement of this product exemplifies the ability for companies to advertise a seemingly new FDA approved medicine by inclusion of an OTC monograph acceptable ingredient.
Dermatology World: Can you describe the OTC skin protectant drug product’ category in more detail?
Dr. Feldman, Dr. Strowd, and Martin: Skin protectant products are defined as products that temporarily protect injured skin or mucous membranes from harmful or annoying stimuli. Products containing cocoa butter, colloidal oatmeal, calamine, and glycerin, among others, fall in the skin protectant monograph. Glycerin, found in the cream mentioned above, allowed the product to be marketed for eczema under the guidelines of the skin protectant monograph, permitting claims such as those quoted above. A product that contains glycerin, along with any combination of other ingredients that are generally regarded as safe, can make claims permitted for skin protectants.
Dermatology World: Can you cite an example of a similar claim in the past?
Dr. Feldman, Dr. Strowd, and Martin: This is not the first case of this occurring in dermatology and likely will not be the last. The promotion of some new extract as safe and effective for the treatment of a disease is reminiscent of claims for a product that was advertised as a banana peel extract effective for psoriasis; it could claim FDA-approval for psoriasis because it included another ingredient, coal tar, for which there was an OTC monograph.
Dermatology World: What is your recommendation to physicians who may receive news items and/or press releases about OTC products that have been FDA-approved’?
Dr. Feldman, Dr. Strowd, and Martin: Because of the impact of eczema and other dermatologic conditions, patients and their physicians are eager to find new, better treatments. However, claims of FDA approval’ of new products should be approached with skepticism. We advise consumers and providers alike to be wary that the term “FDA-approved” may be misleading.
Dr. Feldman is in the department of dermatology at Wake Forest School of Medicine in Winston-Salem, North Carolina. Dr. Strowd is in the department of social sciences and health policy at Wake Forest School of Medicine. Martin is in the Center for Dermatology Research in the department of dermatology at Wake Forest School of Medicine.
