Spring 2016 PHSI Newsletter
OTCs vs. Supplements

When patients visit the front-end of the pharmacy, most assume that the FDA approves all products on the shelf for safety and efficacy. Patients do not distinguish between over-the-counter (OTC) drugs, vitamins, and dietary supplements. Supplements such as fish oil and ginseng, OTC drugs like acetaminophen, and vitamins B6 and D are often viewed with the same level of scrutiny. Lack of public knowledge and proposed regulatory changes the last few years necessitate a refresher on the differences between OTC drugs and dietary supplements.

OTC drugs are developed either through a New Drug Application (NDA) process or under the OTC Monograph Process. The NDA process is primarily only used to gain approval to market an OTC product that was previously a prescription drug. Meanwhile, the OTC Monograph Process allows for the marketing of OTC drug products with active ingredients that are already recognized as generally safe and effective. Active ingredient safety and efficacy, labeling, indications, dosing instructions, and side effect warnings are all reviewed, and once approved, monographs are approved which establish the conditions under which an active ingredient is generally recognized as safe and effective. These monographs set the standards for the OTC therapeutic drug class. As long as a new OTC product meets the conditions already set forth in a monograph, companies can develop OTCs containing those ingredients without pre-approval from the FDA. If a drug does not comply with the monograph, an NDA is necessary before the manufacturer can market the OTC. Although this is a simplified explanation, there is a government review for OTC drugs to ensure safety and efficacy.

Dietary supplements fall under the FDA’s “foods” category and are not subjected to the same approval process as OTCs. According to the FDA, supplements are products taken by mouth that are intended to supplement the diet and contain one or more “dietary ingredients”. They may include vitamins, minerals, herbs, botanicals, amino acids, or enzymes. Supplements must only guarantee that the products are safe and ensure that claims made are not false or misleading. Product efficacy is not required, although many of these products can produce efficacious results in patients. Common product supplements that are often confused for drugs include iron, fish oil, niacin (vitamin B3), calcium, vitamin B12, and probiotics.

FDA plans to monitor dietary supplements more closely and has published draft guidance for the industry on dietary supplement ingredients. However, the FDA published this draft guidance in July 2011, and a final version has yet to be published. This guidance would require companies to submit their new dietary ingredients (NDIs) at least 75 days prior to marketing. The NDI would require that manufacturers provide a description of the dietary supplement, prior history of use, and evidence of safety under its labeled conditions of use. The proposed guidance could create a barrier to market entry for supplement manufacturers. It appears that the FDA is trying to manage supplement use and prevent unsafe products from entering the market. In the meantime, consumers and pharmacists should continue to rely on the USP Verified Mark when choosing supplement products. The United States Pharmacopeia (USP) has developed voluntary standards for developing and testing dietary supplements. Products with the USP Verified Mark have met the most stringent criteria of the program. The date of publication for the final guidance on supplement marketing is unknown, but PHSI will keep you abreast of any changes.