Proposed 2007 grandfathered date change: Limited chance of success and distraction from NDI comment deadline?

By Stephen Daniells

- Last updated on GMT

Related tags Dietary ingredients Dietary supplement Food and drug administration Ndi

Proposed 2007 grandfathered date change: Limited chance of success and distraction from NDI comment deadline?
A proposed change to the date defining ‘grandfathered’ dietary ingredients to 2007 shows the industry there are options to the NDI issue, but it should not distract attention from FDA and the upcoming deadline for NDI comment submissions, say leading trade associations.

The “Dietary Supplement Protection Act of 2011”​ was introduced by Rep. Dan Burton (R-IN) last week with the proposal to fast forward the date defining ‘grandfathered’ dietary ingredients from October 15, 1994 to January 1, 2007.

Changing the date for grandfathered dietary ingredients is not a new idea, with industry notables such as Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), and Michael McGuffin, president of the American Herbal Products Association (AHPA) both suggesting a change of date.

Michael McGuffin, president of the American Herbal Products Association (AHPA), told NutraIngredients-USA: “I suggested that we consider the idea of requesting that the NDI date be reset at a meeting with several other organizations in the summer of 2010.

“Given the general safety of dietary supplements over the last 17 years since DSHEA was passed, it is a reasonable concept. Although the chance of actual passage in the current political environment is probably low, we should keep this idea before us.”


CRN’s Steve Mister authored a blog posting in September 2010 with the proposal to move the date forward to January 1, 2008.

“We floated this idea about a year ago to get people thinking creatively for solutions to the NDI issue,”​ Mister told NutraIngredients-USA.

“[The Burton bill] shows that there are lots of ways to address the NDI issue,”​ he said. “But we at CRN hope it does not take the focus from FDA and the December 2 deadline [for submission of comments for the NDI draft guidance].”

Mister explained that this date was chosen because it was the date of implementation of the adverse event reporting (AER) law. “AERs have been around for four years,”​ he said, “so FDA should know now if there is a problem.”

He said he had no idea why Rep. Burton had chosen the 2007 date.

While he couldn’t comment on the bill’s chance of success, Riëtte van Laack from law firm Hyman, Phelps and McNamara, explained in a blog posting​ that moving the date would decrease “the number of dietary ingredients for which the manufacturing method may have changed, and reduce the chance that industry no longer possesses information about the manufacturing method for a grandfathered dietary ingredient”.

According to the Act, “There are DSHEA ‘grandfathered’ supplements, dietary ingredients, and classified products which were on the market before October 15, 1994, and ‘generally recognized as safe’ for human consumption. FDA regulatory policy, industry practices, and consumer marketplace paradigms have drastically changed over 17 years, but this policy has not.

“The definition of a new dietary ingredient in section 413 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 350b) does not recognize the current safe market in supplements, nor how intensively supplements have been regulated over the 17 years since enactment of DSHEA to protect public health and safety, and should be updated to reflect this reality.”

Please click here to read the proposed legislation​.

Damming the tsunami

In his 2010 blog posting Mister wrote that a proposal to change the date of grandfathered ingredients to January 1, 2008 “would make it a lot easier for companies to demonstrate what was – or was not – on the market [prior to this date] since these records are still readily available”​.

“And it would allow FDA to issue a guidance document on NDIs without creating a tsunami of NDI notifications that would hopelessly backlog the agency for years to come, holding consumer desire for new products hostage in the process,”​ added Mister.

Related topics Regulation NDI draft guidance

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