Dietary Supplement Fda Disclaimer

Fda labeling is one of the most important regulatory requirements for dietary supplements in that it provides the consumer the necessary information on the product.

Dietary supplement fda disclaimer. A 1 no later than 30 days after the first marketing of a dietary supplement that bears one of the statements listed in section 403 r 6 or the federal food drug and cosmetic act the manufacturer packer or distributor of the dietary supplement shall notify the office of nutritional products labeling and dietary supplements hfs 810 center for food safety and applied nutrition food. If a dietary supplement label includes such a claim it must provide a disclaimer that fda has not evaluated the claim. Indeed ensuring that all information concerning that particular dietary supplement is in compliance with fda labeling requirements may be difficult and often very onerous.

The disclaimer must also state that the dietary supplement is not intended to diagnose treat cure or prevent any disease because only a drug can legally make such a claim. Once a dietary supplement is on the market fda has certain safety monitoring responsibilities. Office of dietary supplement programs hfs 810 food and drug administration 5001 campus dr college park md 20740.

The disclaimer must also state that the dietary supplement product is not intended to diagnose treat cure or prevent any disease because only a drug can legally make such a claim. To contact the office of dietary supplement programs email. To contact the office of dietary supplement programs email.

Office of dietary supplement programs hfs 810 food and drug administration 5001 campus dr college park md 20740. The fda published a ruling in january 2000 that explained exactly what kinds of structure or function claims were ok for dietary supplements. And 3 notify fda no later than 30 days after the first marketing of the product that you are making the statement in.

Dietary supplements may not make any claims regarding the treatment of disease. These include monitoring mandatory reporting of serious adverse events by dietary supplement firms.