Dietary supplement and raw ingredient manufacturers (as well as distributors) are responsible for evaluating the safety and labeling of their supplement before entering the market to ensure that they meet all the regulatory requirements of DSHEA. While the FDA does not review labels, the risk of non-compliance could be costly due to competitor vigilance.
The Dietary Supplement Health and Education Act (DHSEA) came into effect in 1994, health care companies were faced with unknown challenges that required conformity to new strict FDA regulations. Under DSHEA, the FDA governs both finished dietary supplement products and dietary ingredients under a different set of regulations than those covering foods and OTC drugs. These rules and procedures can be quite confusing and many suppliers have been found non-compliant and subject to FDA enforcment or litigation from competitors.
NHP Consulting offers a wide range of services to guide companies in labeling, marketing compliance, and claim substantiation. Having a fully compliant label is imperative when launching products into the USA.