NDI Comment Period Drawing to a Close, FDA Receiving Calls to Rewrite, Withdraw Draft Guidance

On the eve of tomorrow’s close of the new dietary ingredient (NDI) draft guidance comment period, Nutritional Outlook is keeping updated on the nature of comments industry members tell us they have submitted to the agency.

The Natural Products Association (NPA; Washington, DC) says it has submitted extensive comments asking FDA to rewrite the guidance. “NPA takes serious issue with the overstepping by FDA in this draft guidance….Safety is, of course, of the utmost importance but there are ways to protect safety without doing unnecessary economic harm. DSHEA was designed to ensure consumer access to safe supplements, and the FDA is obligated to implement this law based on that principle,” the association stated in its comments. (For a full look at the association’s comments, click here.)

Below are some highlights, as well as quotes, from NPA’s submitted comments:

• FDA should not shift onto industry the obligation to prove an ingredient’s grandfathered status. Moreover, the agency should accept industry-developed lists of grandfathered ingredients. “Additionally, NPA supports the idea of opening up a docket for a specified period of time during which companies can submit documentation to substantiate the pre-DSHEA status of ingredients, specifically those from industry lists about which FDA has expressed doubt.”

• FDA should clarify what the 75-day review period entails, including when the “clock stops” if problems are found with a notification or if additional information is required. “As opposed to restarting the 75-day review period each time the company adds substantive information, NPA requests that the agency implement an extension to the original 75-day review period for as long as 25 days….[to] allow FDA appropriate time to review the added information while giving the submitting company a discrete period of time during which to expect a response from FDA.”

• FDA should not require product-specific submissions, but rather, ingredient-specific submissions. “It should not be the responsibility of industry to submit notifications for every combination of dietary ingredients. DSHEA places the burden on FDA to prove that dietary supplements are unsafe. Rather than requiring notifications for each and every supplement containing an NDI, FDA should, in a transparent fashion, publish combinations of ingredients from successful NDI filings that do not require a subsequent filing.” It also adds, “FDA should allow a system for suppliers of the actual NDI to submit the detailed ingredient information as well as the full safety profile for the new dietary ingredient.”

• FDA should not require a food-additive testing level for NDI notifications. “Congress emphasized in DSHEA that dietary supplements are not to be regulated as food additives.”

• FDA should expand its definition of what constitutes chemical altering.

• FDA should clarify the NDI filing implications of ingredient activity as opposed to concentration.

• FDA should clarify the status of microbial ingredients as dietary ingredients, including probiotic ingredients. “FDA should clarify that probiotics are permitted dietary ingredients as long as they are not proven by FDA to be unsafe.”

• FDA should consider synthetic constituents as dietary ingredients. “In the past, the agency has not differentiated between natural and synthetic forms of dietary ingredients…NPA requests that FDA revise its current thinking regarding synthetic botanical constituents to permit them as dietary ingredients.”

• FDA should clarify what constitutes investigation as a new drug. “Many researchers have found they are required to file an IND [investigational new drug] in order to get clearance from institutional review boards to conduct any clinical research. Because of this, it is unclear what ‘substantial clinical investigation’ includes.”

• FDA should take all precautions to protect intellectual property. “NPA is concerned with ensuing confidentiality associated with the intellectual property of ingredients that undergo the NDI submission process…NPA recommends that Dockets write to the submitting company to confirm which pages of each NDI submission will be considered as business confidential an accordingly redacted.”

NPA’s comments reflect many of the main points industry have taken issue with regarding the draft guidance.

Meanwhile, nonprofit health advocacy Citizens for Health says that tomorrow, it will deliver a petition signed by 10,320 Americans calling for FDA to withdraw the draft guidance entirely. The petition is being sent to the U.S. House of Representatives, the U.S. Senate, FDA, and President Barack Obama.

“The history-making petition drive, one which generated over 10,000 signatures in under 10 days, received support and inspiration from many sources,” the organization states.

Of the draft guidance, it says, “FDA is going way beyond simply clarifying existing requirements. It is attempting to drastically change existing law…If this guidance is not withdrawn and its misinterpretation of law is backed by the FDA’s own policy review and enforcement powers, it would cause major disruption in the dietary supplement market; force a significant number of products off the shelves; and, say estimates from Emory University, result in revenue losses of over a billion dollars and the unemployment of over 100,000 Americans.”

Read the Citizen’s for Health petition here: http://tinyurl.com/ndi-petition