§350 Vitamins and minerals

Summary

The federal food agency cannot set upper limits on how strong vitamins or minerals are in certain special dietary foods. The agency also cannot call a vitamin or mineral a drug just because it is stronger than the agency thinks is useful. The agency may not limit how many or which vitamins, minerals, or other ingredients can be combined in those foods. These limits do not apply when the product is marketed for treating or managing a specific disease or disorder, when it is for children under age twelve, or when it is for pregnant or breastfeeding women. Products covered are human foods made for special dietary use that contain any vitamin or mineral and that are meant to be swallowed as a tablet, capsule, powder, softgel, gelcap, or liquid. If a product is not in those forms, it still counts only if it is not sold as regular food and not sold as the only item of a meal or diet. A liquid counts only if it is a fluid meant to be taken in daily drops or other very small measured amounts. Labels for these products are not automatically called misleading just because they list all ingredients or mention non-vitamin ingredients in ads. Labels may not list non-dietary-supplement ingredients except as part of the full ingredient list and as rules require; the agency can make exceptions when listing everything is impractical or unfair. Special dietary use means the food is sold for a particular purpose, such as meeting needs from illness, pregnancy, infancy, allergies, weight issues, sodium control, adding vitamins or minerals, or serving as the sole food in a diet.