Amanda Howard, Esq.
In today’s health-conscious world, dietary supplements have become a significant part of many people’s daily routines. These supplements promise a variety of benefits, from bolstering overall health to addressing specific wellness concerns. However, behind the scenes, a complex web of federal and state laws governs the manufacturing, labeling, and advertising of these dietary powerhouses.
Dietary supplements are classified as “food” under federal and state law, except when they meet the definition of a drug and therefore, are not subject to “drug” laws. Unlike drugs, the FDA generally does not have the authority to pre-approve the safety, effectiveness or labeling of dietary supplements before they hit the market. Instead, the FDA typically steps in post-market to ensure safety and compliance with regulations. Whether this is a good or bad thing is a discussion for another time.
However, don’t let the absence of pre-approval fool you; dietary supplements, much like their pharmaceutical counterparts, must adhere to stringent standards. These products cannot be adulterated, meaning they must meet purity and quality requirements, and they must not be misbranded, ensuring accurate and truthful labeling in accordance with federal regulations.
The FDA’s Regulatory Realm
Enter the FDA, the chief guardian of dietary supplement integrity. Defined under 21 U.S.C. 321(ff), dietary supplements fall within the FDA’s purview. The agency wields its regulatory power through the Dietary Supplement Health and Education Act of 1994 (DSHEA) and the Current Good Manufacturing Practice (cGMP) regulations for dietary supplements. These regulations are all-encompassing, covering every aspect of manufacturing, from personnel and facilities to equipment, production processes, and stringent quality control measures. Interestingly, the United States Pharmacopeia (USP) has issued General Chapter 2750, which outlines Manufacturing Practices for Dietary Supplements and the FDA regulations essentially mirror such guidelines.
The USP: Setting the Gold Standard
As it’s clear the USP had great influence in creation of the federal dietary supplement laws, manufacturers would be wise to participate in the USP’s Dietary Supplement Verification Program, which allows products that meet specific quality standards to proudly bear the USP Verified Mark, adding credibility and legitimacy.
FTC Vigilance in Advertising
While the FDA diligently oversees manufacturing and labeling, the Federal Trade Commission (FTC) takes charge of the advertising front. The FTC ensures that advertisements for dietary supplements are truthful, substantiated by scientific evidence, and devoid of any misleading claims.
Labeling Precision
Lastly, when it comes to dietary supplement labeling, compliance is key. Regulations within 21 CFR 101 et. seq. dictate what information must grace supplement labels. This ensures that consumers have unfettered access to accurate and essential details about the product.
Manufacturers, advertisers and sellers of dietary supplements must remain vigilant, familiarizing themselves with these multifaceted regulations and ensuring that their products meet the stringent safety and labeling standards. Ultimately, these regulatory frameworks are in place to safeguard the health and well-being of consumers, fostering transparency and confidence within the thriving dietary supplement industry.
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