Manufacturers and distributors of dietary supplements are required by law to have substantiation “on hand” that attest to the truthfulness of a claim made for a dietary supplement. NHP Consulting has extensive experience in claim substantiation.
Unique claims are often sought-after distinguishing traits for new products hitting the market. Since the Dietary Supplement Health and Education Act (DHSEA) came into effect in 1994, dietary supplement companies were faced with unknown challenges that required conformity to strict FDA regulations around claim substantiation. At times these standards have been difficult to decipher and predict.
There are three types of claims for dietary supplement: 1) health claims, 2) nutrient content claims, and 3) structure/function claims. Health claims describe the synergistic relationship between a food substance and the effect it has on a disease or health-related condition, whereas food claims characterize the level of a nutrient present in a food substance. Formal health claim approvals are done in a pre-market fashion, but are costly and time-consuming – and rarely successful. Alternatively, there are certain “qualfied health claims” which FDA has made previous rulings on and which are open to the industry to make.
The most popular of the three is a structure/function claim, which illustrates the role of a nutrient or ingredient on the effect of a normal structure or function of the human body. DSHEA has amended special regulatory requirements for structure/function claim as well as general well-being and nutrient deficiency claim. While they do not require FDA pre-market approval, manufacturers/distributors are required to have substantiation on hand that attests to the truthfulness of the claim, and to submit a notification of the claim text to FDA no later than 30 days after introducing the dietary supplement to the market. Our company can file the DSHEA notifications on your behalf and provide you with the evidence package to retain on file at your establishment.
NHP Consulting offers a wide range of services to help guide companies on structure/function claim substantiation as well as claim notification to the FDA. Our team of experts can provide essential guidance and expertise on ensuring proper labeling and marketing.