By law, the FDA does not pre-approve dietary supplements. The FDA treats dietary supplements as a subset of food products and not as drugs. Since supplements are not treated as drugs, they must follow specific rules about dietary supplements, including the types of statements allowed. Although the FDA does not approve dietary supplements, the agency has a role to regulate them.
Approval and regulation of dietary supplements is a sensitive topic. No, the FDA doesn't have to approve supplements before they reach the market. However, that doesn't mean the world of vitamins and supplements is free for everyone. Even so, it's smart to take precautions when choosing the supplement that's right for you.
Multivitamins, vitamin D, echinacea, and fish oil are among the many dietary supplements found on store shelves or available online. Because FDA-approved supplements don't exist, but they're more beneficial for people with specific dietary needs or for people with certain medical conditions, your doctor can help you determine which supplements are best for you, how much you should take (it may be different from what's on the package), if they'll interfere with any medical treatment you're already receiving, or anything else that's specific to your situation. Ascorbic acid was previously approved in multi-fixed-dose combination products (FDCP) as an osmotic laxative for colon cleansing or as an injectable maintenance supplement for those receiving parenteral nutrition. Finally, Ascor was classified as a Type 7 NDA, that is, a drug containing an active component that has not been previously approved in an application, but that has been marketed in the U.S.
U.S. If this is the case, the FDA usually grants a grace period of approximately one year from the date of approval before initiating enforcement actions (e.g. (e.g., a seizure or court order) against these unapproved products. In fact, Harvard Health stresses the importance of selecting a dietary supplement that has been approved by one of these three organizations.
Although the circumstances surrounding this classification are not clear in this specific case, for McGuff Pharmaceuticals, the existence of other similar products with ascorbic acid that are not approved on the market has positive implications. You may have noticed that almost all supplements contain some version of the same message on the packaging stating that the Food and Drug Administration (FDA) has not approved any health claims about the product. Generally, the category of dietary supplements excludes items approved as new drugs, authorized as biological products, or authorized for clinical research under an investigational new drug application (IND) that has entered into force, unless the item was previously marketed as a dietary supplement or as a food. While the summary approval base is not yet available, it is reasonable to assume that it was largely based on the literature for the approval of Ascor due to the historic use of vitamin C (or its food sources) as the sole treatment for scurvy.
Once this grace period has elapsed, and as long as sponsors try to obtain approval for these similar products, McGuff Pharmaceuticals will have a period of de facto commercial exclusivity. Because the FDA doesn't approve dietary supplements before they go on the market, the agency often doesn't know when new products come to market. These three types of statements are not approved by the FDA and do not require FDA evaluation before they are used in the labeling of dietary supplements. In addition to the FDA, there are other independent organizations that approve supplements, even though there are no official supplements approved by the FDA.
In general, the FDA is limited to enforcing regulations after they are marketed because, unlike drugs that must demonstrate that they are safe and effective for their intended use before marketing, the law does not require the FDA to approve the safety of dietary supplements before they reach the consumer...