James Hoadley, Ph.D. wrote an article on ensuring use of legal dietary supplement ingredients for Natural Product Insider. Regulators have a fine focus on dietary supplement products that are mislabeled or misbranded, and brands must be careful when it comes to ingredients and classification as a supplement or food. Read more.
James Hoadley, Ph.D.
FDA is particular when it comes to bodybuilding products (or any dietary supplements) that are mislabeled or misbranded, as evident from their many warning letters and enforcement actions to companies out of compliance. Some of the infractions that get firms into trouble include:
- Labeling a “beverage” or “bar” as a dietary supplement.
- Using substances that do not meet the statutory definition of dietary ingredient in the dietary supplement. This can be a synthetic substance (other than synthetic vitamins or a synthetic conventional food ingredient) or any substance found on the FDA Dietary Supplement Ingredient Advisory List.
- Formulating a product with novel botanical ingredients, or other novel ingredients that have not met the pre-market safety requirements of food ingredients…