FDA issued Warning Letters to firms, citing drug claims associated with topical skin care, hair care, and eyelash/eyebrow preparations, noted on both product labeling and websites. Some examples of the drug claims cited are acne treatment, cellulite reduction, stretch mark reduction, wrinkle removal, dandruff treatment, hair restoration, and eyelash growth. These Warning Letters illustrate an important legal distinction, the difference between a cosmetic and a drug.
When a product is intended for a therapeutic use, such as treating or preventing disease, or to affect the structure or function of the body, it’s a drug, regardless of what its label says.
If an article, such us N-acetyl-L-cysteine (NAC), has been approved as a new drug, then products containing that article are outside the definition of a dietary supplement, unless before such approval, that article was marketed as a dietary supplement or as a food. Furthermore, claims on your website or social media establish that your dietary supplements are drugs, because they are intended for use in the cure, mitigation, treatment, or prevention of disease.
As the marketplace for dietary supplements has evolved, so has the illegal sale of adulterated products which contain ingredients ranging from prescription drugs to controlled substances.
Please note that the U.S. Food and Drug Administration has exclusive jurisdiction over the safety, and primary jurisdiction over the labeling of dietary supplements, while the Federal Trade Commission (FTC) has primary jurisdiction over advertisements for dietary supplements.
Also, food products can be misbranded because the labels failed to declare all major allergens:
- fish (bass, flounder, or cod)
- crustacean shellfish (lobster or shrimp)
- tree nuts (almonds, walnuts, and pecans), peanuts, wheat, and soybeans.
Sesame became the ninth major food allergen effective January 1, 2023.
Food allergies and other types of food hypersensitivities affect millions of people living in the U.S. and there are more than 160 known food allergens. To protect those with food allergies and other food hypersensitivities, the FDA requires companies to list major food allergens or ingredients that are made from major food allergens in specific ways on the label of packaged foods. The FDA also enforces regulations that require food manufacturers to prevent allergen cross-contact or the unintentional incorporation of a major food allergen into a food.
- You must list dietary ingredients without RDIs or DRVs in the Supplement Facts panel for dietary supplements. You are not permitted to list these ingredients in the Nutrition Facts panel for conventional foods.
- You may list the source of a dietary ingredient in the Supplement Facts panel for dietary supplements. You cannot list the source of a dietary ingredient in the Nutrition Facts panel for conventional foods.
- You are not required to list the source of a dietary ingredient in the ingredient statement for dietary supplements if it is listed in the Supplement Facts panel.
- You must include the part of the plant from which a dietary ingredient is derived in the Supplement Facts panel for dietary supplements. You are not permitted to list the part of a plant in the Nutrition Facts panel for conventional foods.
- You are not permitted to list “zero” amounts of nutrients in the Supplement Facts panel for dietary supplements. You are required to list “zero” amounts of nutrients in the Nutrition Facts panel for conventional foods.
Are considered over-the-counter (OTC) drug products, popular items such as hand sanitizers and sunscreens, among many others.
Therefore, Drug Facts labels are required on their packaging. The OTC labeling rule applies to more than 100,000 OTC drug products.
The following information must appear in this order:
- Product’s active ingredients, including the amount in each dosage unit.
- Purpose of the product.
- The uses (indications) for the product.
- Specific warnings, including when the product should not be used under any circumstances, and when it is appropriate to consult with a doctor or pharmacist. This section also describes side effects that could occur and substances or activities to avoid.
- Dosage instructions, when, how, and how often to take the product.
- Product’s inactive ingredients, important information to help consumers avoid ingredients that may cause an allergic reaction.
The Nutrition Facts label is required on most packaged conventional foods and beverages.
The nutrition label for a dietary supplement is called Supplement Facts.
Examples of DVs versus %DVs
Based on a 2,000 Calorie Diet