The draft guidance, available here, is intended to “assist industry in deciding when a premarket safety notification for a dietary supplement containing a new dietary ingredient (NDI) is necessary and in preparing premarket safety notifications,” says FDA in its document.
Under the 1994 Dietary Supplements Health & Education Act (DSHEA), firms are required to notify the FDA if they intend to market a dietary supplement in the US that contains a ‘new dietary ingredient’ (which has not been marketed in the US dietary supplements market before October 15, 1994) and demonstrate that it is safe.
Dietary ingredients used in dietary supplements before this date were ‘grandfathered in’ and considered safe.
The draft guidance maintains this stance, adding that ingredients used in conventional foods but not dietary supplements prior to DSHEA will require an NDI. FDA also states that a dietary ingredient marketed outside, but not inside, the US prior to 1994 are considered to be a NDI.
FDA continues that no authoritative list of grandfathered ingredients exists and that “each supplement manufacturer or distributor is responsible for establishing that the dietary ingredients in its dietary supplements comply with the NDI notification requirements”.
Changes to a manufacturing process are also addressed by the guidance, with FDA noting that such changes that “alter the chemical composition or structure of the [grandfathered] ingredient […] most likely” make the ingredient a NDI. Changes to an established process for a NDI should also be followed by a new NDI notification submission, said the agency.
NutraIngredients-USA.com will produce a more in-depth look at the short- and long-term implications of the guidance, with expert analysis, in the coming days.
To read the guidance, please click here.
Too soon to comment
Leading industry associations and figures are digesting the guidelines, and a deeper analysis of the guidelines and their implications are sure to follow.
John Gay, executive director and CEO of the Natural Products Association (NPA), told NutraIngredients-USA that “FDA deserves credit for meeting the statutory deadline to release the guidance.”
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN) said: “The dietary supplement industry has eagerly awaited this guidance in the hope that it will provide clarity and an appropriate framework for introducing new ingredients and products into the supplement marketplace.
“As FDA has reminded us, this draft guidance document describes the agency’s interpretation of the requirements for NDIs—it is not a new regulation and does not create new rights or responsibilities for the industry. Nevertheless, this draft guidance does represent an important step for the dietary supplement industry—and for the Agency—as it demonstrates further implementation of the requirements of the Dietary Supplement Health and Education Act (DSHEA) and will give companies clearer understanding of FDA’s expectations under the law.
“We will now thoughtfully review the guidance which we view as FDA’s best thinking on the subject and will respond with the industry’s best thinking, which we trust FDA will take seriously. This guidance has potential for short- and long-term implications for our industry and for our consumers’ ability to have access to in-demand products and we want to be sure the guidance is appropriate, reasonable and practical for industry and the more than 150 million consumers who use dietary supplements year after year,” added Mister.