In the Dietary Supplement Health and Education Act of 1994 (DSHEA), a new dietary ingredient (NDI) is defined as “a dietary ingredient that was not marketed in the United States before October 15, 1994 and does not include any dietary ingredient which was marketed in the United States before October 15, 1994.” Dietary supplements marketed before October 1994 are grandfathered if the company can establish that same form or dosage was on the market and the dietary supplement does not contain adulterated ingredients.
NDIs require the manufacturer or distributor to notify the Food and Drug Administration (FDA) seventy-five days before marketing a dietary supplement that contains an NDI. The NDI notification must include information that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling.
- FDA’s NDI draft guidance is so problematic and troubling to small businesses that we would like Congress to request a rewrite of the NDI draft guidance. Based upon language in the NDI draft guidance, most companies would have to submit an NDI for something that is already safe, and our own research into the cost for companies to submit an NDI is approximately $350k-500k. FDA also failed to provide an economic cost analysis in the guidance.
- FDA continues to blur the distinction between dietary ingredients used in dietary supplements and food additive ingredients. FDA continues to link NDI safety to food additive-level of testing protocols and study designs.
- FDA is using import detention as a tool for any probiotic strains and herbs/botanicals not found in their NDI database. Many strains are homologous to other strains in a given species, but FDA’s NDI enforcement strategy seems to be based upon identification at the strain level, rather than a risk of pathogenic elements in a particular genus or species.
- FDA treats synthetic copies of botanical constituents differently from other dietary ingredients (ie. amino acids, vitamins). Synthetic copies are allowed/expected for amino acids and vitamins, and there is no public health issue regarding synthetic copies of botanical constituents.
- FDA wants a grandfathered list with proof demonstrating an ingredient was an old dietary ingredient. NPA would like for FDA to recognize NPA’s safe harbor list of old dietary ingredients, which contains advertisements and labels of products sold in interstate commerce before October 15, 1994 as evidence.
- FDA does not have the capability, manpower and resources to review the volume of NDIs they are expecting to somehow receive under the NDI draft guidance.
- The NDI draft guidance places many dietary ingredients in jeopardy. FDA has traditionally shown enforcement discretion regarding NDIs and only acted if someone failed to file an NDI and there was a safety concern. FDA could change that policy and act simply on the basis of failing to file an NDI notification for a dietary ingredient that has been used for many years.
The draft guidance poses some serious economic challenges for the industry. Based upon FDA’s new enforcement policy, companies will need to either file NDI safety submissions or take their products off the market if they fail to produce documentation demonstrating that the dietary ingredient in question was grandfathered and offered for sale before October 15, 1994.
NPA believes these proposed changes could have far-reaching implications for the dietary supplement industry. Guidance documents are helpful for the industry to know FDA’s thinking on regulations; however, in this case, FDA has significantly overstepped the line Congress drew in DSHEA between dietary ingredients and food additives. FDA should provide reasonable draft guidance for NDI notification as long as the guidance is reasonable. FDA’s guidance suggests most dietary ingredients require notification. If a company uses an NDI in association with other dietary ingredients, FDA requires safety testing for each dietary supplement ingredient combination containing that NDI. This is economically unreasonable.