McCain Bill Would Upend Supplement NDI Exemptions

Sens. John McCain and Byron Dorgan introduced legislation that would undo grandfather status for dietary ingredients established by DSHEA and upend the new dietary ingredient notification process.

The bill would strike from the Food, Drug and Cosmetic Act language that exempts from the NDI process ingredients that were on the market before October 1994. Instead, the bill would authorize FDA to create a list of "accepted" ingredients.

The bill requires firms to submit safety data or history of use evidence for products that have been considered safe for 15 years, or risk being deemed adulterated.

If passed, the measure could leave firms scrambling for data they have not had to maintain and could make many ingredients subject to reapplying as NDIs or being ordered from the market.

The Arizona Republican and North Dakota Democrat on Feb. 4 introduced the Dietary Supplement Safety Act of 2010 to tighten regulation of the products.

The bill, S. 3002, also would require supplement firms to annually submit all their adverse event reports to FDA, rather than only reports on serious events as currently required.

In a Feb. 3 press briefing, McCain said the bill would give FDA mandatory recall authority for supplement products found to be "unsafe or harmful." He said the Senate Health, Education, Labor and Pensions Committee could take the bill up within a month.

McCain and U.S. Anti-Doping Agency CEO Travis Tygart, accompanied by athletes who spoke of using supplements with undeclared ingredients, discussed concerns about adulteration and contamination, maintaining that athletes particularly are vulnerable because many regularly use supplements for conditioning. Pro athletes and others competing under rules banning the use of performance-enhancing substances could test positive for an illegal substance if they take an adulterated product.

McCain said a 2009 Government Accountability Office ¹ report on supplement regulation shows improving the regulations is crucial (² (Also see "Congress Says GAO Report Supports Increasing Supplement Oversight" - Pink Sheet, 9 Mar, 2009.)).

His bill reflects recommendations Tygart outlined in September 2009 testimony before the Senate Judiciary Subcommittee on Crime and Drugs. The same recommendations came from a coalition of sports and health organizations USADA announced in December (³ (Also see "USADA Builds Team To Change Supplement Law, Cites "Lax" Regulations" - Pink Sheet, 7 Dec, 2009.)).

The bill would "turn that NDI provision upside down," said Scott Polisky, a food and drug attorney who represents Jarrow Formulas.

The bill defines supplements that contain new dietary ingredients as adulterated unless the ingredients have a history of use or other established safety evidence.

Under the Dietary Supplement Health and Education Act, ingredients used in products on shelves before October 1994 are grandfathered for use, but firms are required to submit notifications to FDA within 75 days of introducing a product containing a substance not used before that time.

FDA has not frequently pressed manufacturers and firms marketing supplements to provide evidence supporting claims that their products contain only grandfathered ingredients, stakeholders say. This has proven key to many supplement firms because they do not incur costs or expend other resources to compile and maintain evidence that their ingredients are pre-DSHEA and do not require NDI notifications.

However, McCain's bill would require firms to show their products do not need NDI notifications.

Tygart said the legislation would help eliminate noncompliant firms but "not place unreasonable burden" on others for compliance. He said that the bill would not lead to "a fundamental reset" of DSHEA but would "fulfill its intent."

While firms currently can launch products with ingredients addressed in NDI notifications without receiving acknowledgment from FDA, the agency can question NDIs and rule that an ingredient should not be on the market.

Tygart maintains that firms commonly market products without proof their ingredients were used pre-DSHEA, and some of those products are unsafe or have undeclared ingredients.

However, the supplement industry argues that firms are submitting fewer NDI notifications because FDA is rejecting more of them and has yet to publish a guidance that would help manufacturers prepare successful notifications.

Council for Responsible Nutrition President Steve Mister said the NDI provision is "concerning," particularly because it requires FDA to create a list of "accepted" ingredients. Any ingredient "not on it has to go through the NDI process," he said in an interview. Amending DSHEA's NDI language is "a bad idea," Mister added. Instead, FDA should publish the long-awaited guidance to give manufacturers and ingredient suppliers a better sense of what constitutes an NDI.

Mister said with FDA already overburdened and lacking resources, it would be difficult for the agency to take on the additional NDI responsibility.

Natural Products Association Executive Director John Gay agrees. With additional resources, FDA could be more effective in eliminating "the relatively few bad actors who market adulterated products," Gay said.

What's Serious?

The bill would require firms to annually submit non-serious AERs, in addition to serious AER submissions firms are required under the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 to submit within 15 days.

Mister said the requirement to submit all AERs is "a deal-breaker for us."

Other stakeholders oppose reporting all AERs, and point out FDA already has access to all of a firm's adverse event information during facility inspections. NPA states that FDA has clarified receiving all supplement AERs would not be useful and would overload the agency's database capabilities.

According to the GAO report, FDA officials said while receiving information on all adverse events related to supplements could enhance FDA's ability to detect signals of potential toxicity over time, the agency "raised concerns about its ability to efficiently and effectively analyze the information to identify unsafe dietary supplements."

The report pointed out FDA is developing methodologies to mitigate this concern and improve data mining for safety-related signals.

Mister observed that by making an annual requirement for submitting all AERs to FDA, McCain's bill acknowledges it is not feasible for FDA to receive all reports within the same 15-day deadline allowed for serious event reports.

On the other hand, CRN does not see annual filing providing benefit to consumers. "Instead, it could do the opposite by stretching the agency beyond its limits," Mister said in a Feb. 4 release.

"Even this I don't believe FDA wants," he said. "FDA itself has stated that this would overburden the agency and would not help protect consumers."

However, Tygart says the threshold is "entirely too high" for submitting supplement AERs to FDA. As far as processing and handling a larger database, FDA could develop formats for submitting information so the agency is not overwhelmed, he said in an interview.

Retailers Shoulder The Burden

McCain's bill would require retailers and manufacturers to obtain written confirmation from suppliers or product marketers of compliance with facility registration and product notification.

CRN says this provision "would deter retailers from offering a wide variety of legitimate supplements to consumers or would overburden manufacturers."

The legislation also would require registration with FDA by all firms that handle supplements at virtually every stage of production and distribution. These firms also would be required to submit to FDA a list of all supplements they handle, according to the bill.

Additionally, a full list of ingredients contained in each supplement, and a copy of labeling used for each product should be provided, the bill states.

Pending food safety legislation in both the House and Senate would give FDA mandatory recall authority over all food products, including supplements.

Stakeholders say the recall provision in McCain's bill is duplicative of provisions in pending food safety legislation, but Tygart argues the food safety bills do not go far enough.

McCain's bill says a product can be recalled if misbranded or adulterated or if "there is a reasonable probability" that using it may cause serious adverse health consequences or death.

- Katie Stevenson ( ⁴ [email protected] )