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Lawyer: FDA line on grandfathered ingredients was not made clear

3 commentsBy Elaine Watson , 12-Jul-2011
Last updated on 12-Jul-2011 at 18:42 GMT

A leading food law expert and the Food and Drug Administration’s (FDA’s) dietary supplements chief agreed to disagree over several key aspects of the FDA’s draft guidance on new dietary ingredients (NDIs) during a spirited conference call with stakeholders yesterday afternoon.

While the FDA’s Dan Fabricant attempted to debunk the “myths and hyperbole” surrounding the document, Scott Bass, who heads the global life sciences team at law firm Sidley Austin, said its uncompromising stance on ‘grandfathered ingredients’ was not in the spirit of the legislation it was designed to clarify.

The two were exchanging views in a webinar/conference call organized by the Natural Products Association to discuss the guidance document, which has provoked a storm of controversy in the trade.

An implicit understanding?

While the FDA had never explicitly said that industry lists of ‘grandfathered’ ingredients used in supplements pre-1994 were authoritative, there was always an “implicit understanding” that they counted for something, claimed Bass, who was a major contributor to the drafting of DSHEA (Dietary Supplements Health and Education Act).

He added: “There just aren’t records for a lot of these ingredients and that was known at the time. If you got in before October 1994 with no known safety problems you were grandfathered in. That’s where we thought things were until the last couple of years.

“There was an implicit understanding that what was on these lists [compiled by industry in the mid to late 1990s] was acceptable evidence.”

The guidance, however, suddenly raised fresh legal questions over the status of “thousands if not tens of thousands of ingredients that have been on the market for 20 years”, he said.

“The industry is surprised that what they thought were acceptable products for 15-20 years now might be on the block.”

But Fabricant responded: “I was surprised that people say they are surprised. These [industry] lists have never been considered to be authoritative… The expectation was that people had records.”

Manufacturing changes and NDI triggers

Other areas in which the two agreed to disagree was on the issues of whether changes to the manufacturing process, new solvents or new extraction methods should trigger an NDI notification, and how much safety data firms should supply to prove their ingredients were safe.

While the dismal number of NDI notifications in comparison with the number of new supplements launched clearly indicated firms had not been filing NDI notifications where they should have been, the answer was not to raise the bar such that they were even less likely to do so, argued Bass.

“I think that the industry has handled this poorly and I think you’re right that we should do something about it, but [the answer] is not to make the requirements so strict that they think it’s not worth doing it in the first place.”

Why, for example, asked one caller in the Q&A session at the end of the webinar, should it be necessary to submit an NDI notification over a small change in the ratios of the long chain omega-3 fatty acids EPA to DHA in one fish oil supplement versus another? Was this really a big safety issue?

Said Fabricant: “If it is a different ingredient, a different chemical entity, then it should trigger an NDI notification.”

Click here to read our interview with Dan Fabricant.

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3 comments (Comments are now closed)

Grandfathered??

Since when did we look at nutrition as something that is grandfathered? What a waste of our government’s time.

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Posted by Carmina Lolley RN
15 July 2011 | 03h33

The real need

The cost of putting a supplement, a process or an ingredient through the approval process needs to COME DOWN dramatically. The FDA needs to make the economics work rather than supporting a situation in which only super big business can participate.

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Posted by Elizabeth Freeman
13 July 2011 | 01h09

Newsflash: FDA Inquisition Indicts Nutrients...get a life...

For over thirty years, I have been an activist for legislated freedom of choice in medical treatments, patient advocacy and nutraceutical intervention and advancement. I am still shocked and dismayed that a most powerfully entitled federal agency, as the FDA, continues to indict, restrict and ban nutrients, while it allows the continued abuse and public sale of cigarettes, the most prolific drug compounds in civilized history.

Instead, they engage millions of tax-payers' dollars in implementing an inquisition against nutritional ingredients, the only bonafide substances required by every cell in the human body for survival,repair and regeneration.

Why not address the dangerous, and often lethal, drugs masquerading as medical modalities, such as the highly questionable statins, multiple vaccinations, rampant perscriptive use of antibiotics, anti-depressants, pain killers and off-label use of anti-psychotic drugs to frail seniors or ritalin to vulnerable children, to name a few?

These drugs repeatedly cause iatrogenically-induced pathologies, many of which result in debilitating and fatal consequences.

The FDA should be far more concerned with a witch hunt of the medical drug cartel, than to wage war on Nature and the inevitable right of all Americans to have ultimate sovreignty over their own welfare and well-being.

Remember, you can live an entire life without ever needing a single drug. Try living without nutrients for one second and you are history.

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Posted by Lorna Zilba
12 July 2011 | 21h31

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