Special edition: NDI draft guidance reaction

The wait is over: FDA releases NDI draft guidance

By Stephen Daniells

- Last updated on GMT

Related tags Dietary supplements Dietary supplement Draft guidance Ndi

The wait is over: FDA releases NDI draft guidance
The Food and Drug Administration (FDA) has released the much anticipated New Dietary Ingredient (NDI) draft guidance, meeting its statutory deadline for the release of the document.

The draft guidance, available here​, is intended to “assist industry in deciding when a premarket safety notification for a dietary supplement containing a new dietary ingredient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The draft guidance maintains this stance, adding that ingredients used in conventional foods but not dietary supplements prior to DSHEA will require an NDI.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.

Related topics Regulation NDI draft guidance

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Posted by Mahmood Mohiuddin,

I work for IFANCA, the largest third party halal certification agency. There are numerous operations that are in the Nutrient supplements operations, scattered all over the world. With the implementation of these guidelines, will the overseas operations be required to register with FDA, like the pharmaceutical industry currently does? What is the requirement for listing ingredients?

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Another slight of hand..

Posted by banh,

If the health care scam sets protocols for supplements, they will begin to issue lists of "accepted, accredited and endorsed" companies and products. Products not on their lists will not be deductible or covered by insurance. Same as the rest of insurance protocols. The large companies which can post budgets to have "newer" ingredients approved will benefit and smaller companies will not participate in the market. In effect, the latest and most effective ingredients and discoveries will be left in the hands of the new "system" and classified as drug-like substances. This also gives large companies the privilege and protectionist space to synthesize and patent lab clones of botanicals.

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EU policy comes to America.

Posted by banh,

To Bill Sardi,
I believe that what's happening in Washington with this new requirement will separate well-established supplement producers from smaller companies and is nothing short of corruption. Orin Hatch is right in the middle of this garbage. Utah as you know is overflowing with supplement manufacturers, and I believe that the proposed new "tax deduction" for supplement purchases is just the first subtle step toward "preferred" companies which will supply the atrocious Obama health care scam... I mean "plan".. Basically, we will probably see a "supplement czar"-type official and quasi-government favored companies.

Of course, Orin Hatch is plugging away to place Utah at the top of the heap, knowing that the well-establish Utah industry can easily handle any new FDA demands with flying colors. This is really beginning to stink like hell, and the large supplement companies seem to be napping.. They are closing their eyes dreaming of the bloody fortunes they will make with the health care plan.

Can you ONLY imagine the billions of dollars these big pharma-like companies will put in their pockets once the federal health care system begins to issue RFP's for "vitamin contracts"? The supplement business is about to go "pharma" in its business structure, and this delay you are wondering about is just a snippet of the corruption. Utah's economy is about to skyrocket.. among others. Why else would Orin Hatch be chopping away at an industry his state prospers by if his state wasn't going to cash in on the new "policies"? This is banana republic corruption. The only people napping are the ignorant public.

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