Reed Tech recently hosted a series of OTC-focused webinars featuring Reed Tech subject-matter experts and our industry friends and colleagues from Amin Talati Wasserman, LLP. The series, which took place throughout the summer, provided fundamental information on Over-the-Counter (OTC) drug monographs then took a deeper look at five types of OTC drug monographs— COVID-19 related, topical, oral, homeopathic and cosmetics and other combination products.
According to the FDA, "An OTC monograph is a 'rule book' for each therapeutic category establishing conditions, such as active ingredients, uses (indications), doses, labeling and testing, under which an OTC drug is Generally Recognized As Safe and Effective (GRASE) and can be marketed without a New Drug Application and FDA pre-market approval." Whereas, Homeopathy is an alternative medical practice that was developed in the late 1700s and is generally based on two main principles. First, that a substance causing symptoms in a healthy person can be used in diluted form to treat symptoms and illnesses, a principle known as "like-cures-like"; and secondly, the more diluted the substance, the more potent it is, which is known as the "law of infinitesimals."
Over-the-Counter topical pharmaceutical products include products such as sunscreen, topical acne treatments and more. The acne final monograph requirements are regulated under 21 CFR Part 333 and the sunscreen tentative final monograph requirements are regulated under 21 CFR Parts 201, 310, 347, 352. Both include common active ingredients & permitted concentrations, statement of identity, indications, warnings and directions, as well as other requirements.
Over-the-Counter oral pharmaceutical products include internal analgesics (i.e. ibuprofen), oral healthcare products, cold, cough and allergy products and more. Common advertising claims for these products include "clinically proven", "natural" and "extra strength". As a result, FDA holds the companies that manufacture and distribute these drug products to very high labeling claim standards. They must be truthful and not misleading, scientifically valid and reproducible and supported by substantial evidence, to name a few.
Over-the-Counter homeopathic products include those products with ingredients derived from plants, healthy or diseased animal or human sources, minerals and chemicals. The FDA does not currently approve any homeopathic products, so anything labeled as homeopathic has not been tested for safety or efficacy. These products often contain ingredients derived from plants, animal or human sources or certain minerals and chemicals.
COSMETICS + OTHER COMBINATION DRUG PRODUCTS
Over-the-Counter combination drugs include moisturizers marketed with sun-protection claims, anti dandruff shampoos marketed to both cleanse and treat dandruff, toothpaste marketed with fluoride, etc. FDA has put the following parameters in place to determine if a product is a cosmetic. Cosmetics are for cleansing, beautifying, promoting attractiveness or altering appearance. Cosmetics cannot affect the structure or function of the body or treat, cure, mitigate or prevent any disease. If a product falls into this 'cosmetic' category, the FDA has relaxed regulatory standards, even compared to most over-the-counter drug products. However, a cosmetic can contain drug claims, such as a shampoo that cleans hair but also help to treat or prevent dandruff and are subject to stricter FDA requirements as OTC + Cosmetic Products. OTC + Cosmetic Products must be labeled and registered as drugs.