FDA’s most striking attempt to exceed the regulatory limits Congress established in the Dietary Supplement Health and Education Act is the July 2011 draft guidance on new dietary ingredient notifications, according to some industry stakeholders.

While acknowledging that the NDI notification requirement is needed to help keep unsafe products off the market, the stakeholders say the agency’s draft guidance would stifle the launch of many new products and would require unnecessary notices for any existing products.

“It was a broad overreach,” said supplement industry attorney Marc Ullman. “If adopted it would be rulemaking by guidance,” he added.

DSHEA requires notifications to the agency 75 days before a product is made available to consumers, for ingredients not present in the food supply when the act was passed in 1994.

Stakeholders contend products containing ingredients available before DSHEA or NDI-compliant ingredients should not become subject to the NDI requirement when a manufacturing process is changed, when a different dosage is used or when compliant ingredients are combined.

FDA officials, however, contend such changes can affect the safety profile of an ingredient and therefore make an NDI notification necessary ([A#05130715008]).

“My reaction is that’s because they think everything is an NDI,” said food and drug attorney Wes Siegner. “They added all these qualifiers on [the NDI] provision that aren’t, as far as I read it, in the act.”

“The tension I think keeps things in equilibrium because FDA is pushing in one direction and we’re pushing in the other. Where there are real legitimate needs that need to be addressed, the industry will agree.”

– CRN President Steve Mister

Siegner asserts that DSHEA does not direct the agency to look at a firm’s manufacturing processes for the purpose of determining whether an ingredient is an NDI.

“It’s the ingredient that is safe or not safe. If you have a different manufacturing process you could end up with different things as contaminants in the product, but that’s the responsibility of the manufacturer. That happens whatever you’re dealing with,” said Siegner, of Hyman, Phelps & McNamara in Washington.

He maintains that because FDA’s 2007 final rule for supplement good manufacturing practices already requires firms to ensure the safety of all ingredients when they make manufacturing, formulation or other changes, requiring an NDI notification following such changes would be unnecessary and redundant.

“This focus on tweaking manufacturing just takes the whole intent of Congress to a level it should never go to. It’s going to totally screw up the NDI process because they’re going to end up with so many NDI filings they’ll never be able to deal with it. Why would you want to stop manufacturers from improving manufacturing techniques?”

Ullman said the GMPs final rule, published after FDA considered substantial input from the industry, provides a platform manufacturers should use to achieve and maintain regulatory compliance. The rule covers everything from ingredient identification to production processes, and from labeling products to compiling adverse event reports Also see "Consent Decrees Are Last “Dance” For Supplement GMP Violators" - Pink Sheet, 26 November, 2012..

“You’ve got to look at the set of the regulations as a whole,” said Ullman, a partner in New York firm Ullman, Shapiro & Ullman.

Council for Responsible Nutrition President and CEO Steve Mister said in four meetings with FDA officials over the past year about the draft guidance, supplement industry trade groups emphasized “the fact that the NDI process really should be focused more on ingredients and not finished products.”

Mister said requiring NDI submissions for products containing ingredients already recognized as compliant not only will create more work for FDA, but also drive up firms’ costs. When firms use ingredients for which a supplier has submitted an NDI notification, they should be allowed to rely on the single NDI, he said.

“They could sort of piggyback on the notification if they’re buying from that supplier. If that is the direction the agency goes, that certainly brings down the costs,” he said.

In July 2012 FDA said it would revise the draft through consultation with stakeholders – in part as a response to supplement industry allies in Congress. According to its most recent list of program priorities, the Center for Food Safety and Applied Nutrition intends to publish the revised guidance by the end of 2013 and a final version in 2014, though that timeline may prove overly ambitious for the agency ([A#05130909011]).

Push And Pull

Siegner sees the NDI notification guidance as FDA’s latest attempt to tighten its regulation of supplement manufacturing and marketing.

For prologue, he points to DSHEA and the 1971 Proxmire Amendments to the Food, Drug and Cosmetic Act, which limited the agency’s power to reclassify vitamins as drugs and allowed limited claims for special dietary needs, and resulted in the debut of the “diabetic foods” aisle in grocery stores. ([A#05130415003]).

“FDA is going to constantly try to push the ball closer to the premarket approval type of situation. That’s not going to end.”

– attorney Wes Siegner

“There’s a cycle that goes on every 18 years or so. FDA is going to decide that somehow, some way they really need to get premarket approval of these products. So every 18 years or so they get slapped around by Congress saying, ‘That’s not your job. That’s not what we intended,’” he said.

“Now it’s kind of happening again. They issued what I think the industry and Congress felt was a pretty crazy guidance document,” Siegner added.

Mister acknowledged that without industry’s vigilance, FDA likely would exceed DSHEA’s limits on regulation of supplement manufacturing and marketing.

“I think there are opposing forces at work here. FDA as far back as anyone can remember has wanted more regulation of the industry,” he said.

“FDA would like to have a lot more regulation of the industry than they do. There’s always going to be that push in the direction of more and more regulation when it comes to regulating dietary supplements as if they were drugs or food additives. The industry’s going to push back. And we always have, we always will.”

Premarket Approval

In Siegner’s view, officials at FDA have wanted premarket approval of supplements for decades. And the NDI draft guidance is another attempt to establish premarket approval, he says, by rewriting definitions to force more products into the notification process.

“There’s always going to be tension here and FDA’s going to push, push, push until they get premarket approval. The only way that’s not going to happen is if the industry says, ‘We’re going to push, push, push and protect our market,’” he said.

“As long as there’s that tension we’ll probably end up somewhere in between, but FDA is going to constantly try to push the ball closer to the premarket approval type of situation. That’s not going to end. You’re never going to satisfy FDA that industry is doing it right and industry as far as I can see is never going to trust FDA to have premarket approval authority.”

FDA officials declined to comment on assertions that the agency would prefer to have premarket approval authority for dietary supplements.

Tension And Equilibrium

Mister and Ullman do not see FDA’s actions as a push for premarket approval authority. They note that the agency solicits the industry’s cooperation in ensuring safe vitamins, minerals, herbals and other nutritional products are available to U.S. consumers.

The industry supported passage of 2006 legislation requiring firms to submit serious adverse event reports to FDA, and trade groups and other stakeholders work with the agency to keep adulterated supplements off the market.

“The tension I think keeps things in equilibrium because FDA is pushing in one direction and we’re pushing in the other. Where there are real legitimate needs that need to be addressed, the industry will agree,” Mister said.

Mister said the supplement industry is sensitive to congressional attempts to amend DSHEA and impose greater regulatory burden on firms, such as the Dietary Supplement Labeling Act, introduced this and in previous years by Sen. Dick Durbin, D-Ill., to require firms to register new products with FDA within 30 days of launching; and legislation Sen. John McCain, R-Ariz., introduced in 2010 to require FDA to release NDI notification guidance within six months and to notify the Drug Enforcement Administration when any dietary ingredient is found to contain anabolic steroids or steroid-like substances.

Durbin’s bill has gained little traction in Congress and has not moved out of committee, while language in McCain’s legislation was made part of the Food Safety Modernization Act (Also see "In Brief: Acetaminophen Warnings, OTC HSA Bill, Durbin’s Supplement Reg Bill" - Pink Sheet, 5 August, 2013. and Also see "McCain-Dorgan NDI Guidance, Steroid Provisions In Senate Food Safety Bill" - Pink Sheet, 29 November, 2010.).

“Where the push is too strong … the industry pushes back and says, ‘No, we will not go there. There is no reason for that kind of regulation of these products.’ That keeps the opposing forces in equilibrium,” Mister said.

FDA NDI Draft Is A Push For Tighter Supplement Regulation – Stakeholders

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