The agony and the ecstasy: A year in the life of the trade association…

By Elaine Watson

- Last updated on GMT

Related tags: Ndi draft guidance, Dietary supplement

John Gay: We will have to seriously consider taking the fight to Capitol Hill or the courts if FDA does not substantially revise its draft guidance on NDIs
John Gay: We will have to seriously consider taking the fight to Capitol Hill or the courts if FDA does not substantially revise its draft guidance on NDIs
Not surprisingly, the FDA's draft guidance on new dietary ingredients (NDIs) is top of the list for most trade associations when asked what is keeping them awake at night as we head into 2012, but it is not the only thing causing sleepless nights.

The offending document – unveiled just before Independence Day – certainly killed the holiday buzz, admits Council for Responsible Nutrition (CRN) chief executive Steve Mister:

Possibly our biggest frustration in 2011 was when FDA finally released the long-awaited NDI draft guidance, and we realized what we were getting was a proposal to rewrite the law.”

The FTC has been ‘overreaching in its interpretation of allowable advertising claims’

But “negative research that attracted sensational media attention but that is fundamentally flawed” ​along with “tainted products masquerading as dietary supplements”​ were also pretty high on the list.

Indeed, the latter remains a major frustration because the culprits are "fringe players and do not represent the industry, but yet it is far too easy for them to become the poster children for the industry in the press”,​ he adds.

Meanwhile, Natural Products Association (NPA) chief executive John Gay​said he was worried about “increased activity by the Food and Drug Administration (FDA) with a growing number of GMP inspections”.

He added: “We’re also concerned that the Federal Trade Commission (FTC) has been overreaching in its interpretation of allowable advertising claims. And with Congress looking for more revenues, we must watch for proposals that set excessive regulatory fees for the industry.”

‘The mainstream press continues to misinterpret and misreport scientific studies’

Harry Rice, director of regulatory and scientific affairs at the United Natural Products Alliance (UNPA), saves his wrath for the mainstream media, however, which he argues "continues to misinterpret and misreport scientific studies, thus influencing consumer confidence".

He adds: "And once again we were faced with the misconception that the dietary supplement industry is unregulated. This simply isn't true."

American Herbal Products Association (AHPA) president Michael McGuffin echoes this view: "And too many times, the misinformation about this class and how it is regulated is repeated, especially in mainstream media."

Achievements in 2011

But the trade has fought back on many fronts, claims Gay. “A lot of hard work was put in by NPA staff, members and counsel to produce our substantive, thoughtful comments to FDA​ [on the NDI draft guidance].

“And while that was going on, we were in regular communication with the other associations in the industry in order to present a united front to the FDA.

“I’m also proud to say that we achieved our 750th natural certification under the popular Natural Seal program, the first and only natural certification in the US.”

Rice also cites UNPA’s efforts to spread the word about the guidance, although “whether or not such exhaustive communication will be classified as a success” ​will only “be determined in time”, ​he cautions.

At global omega-3 EPA and DHA association GOED, meanwhile, executive director Adam Ismail notes that membership “more than doubled ​[in 2011], signifying the importance of GOED to the long-chain omega-3 category”.

He adds: “GOED and a group of its members also sponsored a meta-analysis published in the British Journal of Nutrition comparing doses of EPA and DHA required for optimal cardio protection. This demonstrated that 250mg of the long-chain omega-3s is the minimum requirement to reduce the risk of some coronary heart diseases.”

While it is “hard to brag about playing defense”, ​notes Mister, ​the CRN has “had a pretty successful year in getting the industry’s viewpoint heard” ​on several fronts, while its “government relations team has succeeded in inoculating the 112 new freshman members of Congress to our issues”.

The AHPA, finally, highlights several achievements, including the launch of KeepSupplementsClean.org, its relaunched and updated NDI Database, its new rules on the labeling of undiluted essential oils and 1,3-dimethylpentylamine (DMAA), and amendments to its guidance policy on residual solvents in extracts.

Priorities and ambitions for 2012

​So what’s top of the priority list for the sector's associations in 2012?

The NPA plans to work with all stakeholders to “push the FDA to substantially revise” ​the NDI draft guidance, says Gay.

And if this doesn’t happen? “NPA and our allies will have to seriously consider taking the fight to Capitol Hill or the courts​.”

Meanwhile, the campaign vs Senator Durbin’s Dietary Supplement Labeling Act is “ongoing with nearly 12,000 emails sent to Congress by consumers and the industry opposing these unneeded new regulations”, ​he says.

The AHPA's McGuffin says the trade must challenge any "congressional action that seeks to limit consumer access to safe dietary supplements​", but says "compliance with cGMPs is the most important issue that the dietary supplement industry needs to address in 2012".

An upgrade to the US qualified cardio health claim on omega-3s

GOED will be “pursuing an upgrade to the US qualified heart health claim, submitting an application for a heart disease risk reduction claim in the EU, and completing our comprehensive assessment... on EPA and DHA to combat efforts to establish an upper limit in the EU”, ​reveals Harry Rice, vice president, scientific and regulatory affairs.

Finally, the CRN will be “expanding the industry’s effort to help combat economically motivated adulteration and strengthening our activities to combat tainted products masquerading as dietary supplements”, ​says Mister.

Note:​Since this article was first published, John Gay has left the Natural Products Association. See our coverage here​.

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1 comment

19,927 letters sent to U.S. Senate from CFH Supporters

Posted by James J. Gormley,

The number of letters to the Senate is much higher than 12,000. In fact, since June 19th, 19,927 letters in opposition to the Dietary Supplement Labeling Act were sent to the U.S. Senate from Citizens for Health supporters alone, FYI.

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