UPDATE: Several sources have told INSIDER Sen. Blumenthal withdrew his amendment for consideration during the Military Authorization bill markup. As stated in our original coverage, there is still a chance Blumenthal could introduce this amendment or other supplement-focused legislation on the Senate floor in the coming weeks.
Sen. Richard Blumenthal (D-Connecticut) has announced plans to propose an amendment to the National Defense Authorization Act (NDAA) for Fiscal 2017 that would require dietary supplements sold on military bases, including commissaries and retail stores, to first undergo independent third party verification of quality standards. The dietary supplement industry has already mobilized its response to the possible amendment, criticizing the proposed requirements as redundant, burdensome and costly.
Unlike last year’s attempt by Blumenthal and Sen. Richard Durbin (D-Illinois) to amend the NDAA, this year’s proposal appears on track for introduction in the Senate Armed Services Committee’s markup of the bill, which is ongoing this week, and will not include last year’s proposals to create a military-specific adverse event reporting (AER) system and a program for monitoring supplement intake by military personnel. Those proposals were challenged last year for being duplicative and unnecessarily costly and burdensome, and this year’s amendment faces the same criticisms.
“CRN opposes this amendment because it is another form of pre-market approval that would be duplicative for companies already following the law," said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), in a statement available on the CRN website.
Loren Israelsen, president of the United Natural Products Alliance (UNPA), also voice opposition to the proposed amendment, saying, "The United Natural Products Alliance has been working closely with our senior political advisors and the rest of the industry to oppose this amendment, which is not needed and potentially burdensome and which could set an unwise precedent for a new and unnecessary type of pre-clearance or pre-approval for dietary supplements.”
“Some companies already choose to use one third party certifier or another, and it is laudable they want to do that," Mister told INSIDER, “but to make it mandatory ignores the fact that there are requirements in federal law, including requirements that FDA inspects these facilities for dietary supplement GMP [good manufacturing practice] compliance; if a company follows all the GMP and labeling requirements and they get an inspection, that should be enough."
Mister further noted some of the biggest brands in supplement space do not use third party certifiers because the brands themselves are symbols of quality to consumers. “Some of those companies don’t use third party because they manufacture to a high pharmaceutical level quality," he said, adding these companies meet or exceed the law in terms of quality standards.
Highlighting the potential cost burdens under Blumenthal’s amendment, Mister noted, “Considering a company with 100 different formulations, in order to get those products into a commissary, they’d have to get third party certification for each product."
There is also the fact the U.S. Military can decide on its own which products to stock and what to require of such products to ensure quality, without any input from Congress. “Individual retailers make those decisions all the time, such as what products to stock on shelves," Mister noted.
“The Armed Services can already require that a supplement is in compliance with Defense Commissary Agency policy on inventory carried by commissaries,” noted the Natural Products Association (NPA), among its talking points on the potential amendment proposal from Blumenthal. “Many soldiers get supplements from family members sending them in the mail. Are we going to require these be 3rd party verified as well?”
The Defense Department can and has acted on its own behalf to safeguard its soldiers from potentially harmful products. “A few years ago, with DMAA, the military was the first to pull DMAA products even before FDA declared the ingredient to be illegal in dietary supplements," Mister reminded. “We’ve seen the military, in situations where there is concern over public health, act very quickly and very responsibly to protect their soldiers."
CRN found out on Monday, May 9, about Blumenthal’s intention to offer the amendment in the Armed Services Committee markup of NDAA and has been working since then to reach out to committee members, which include Sens. Martin Heinrich (D-New Mexico) and Mike Lee (R-Utah).
With Blumenthal’s approach this time being a narrower amendment offered in committee, instead of the broader amendment offered on the floor last year, industry can better focus its efforts to counter the amendment.
“This allows us to zero in on one policy issue rather than deal with the three or four different things that were in the earlier amendment," Mister explained. “Now we can focus on why this is a really bad idea for consumers to have a mandatory certification program." He added CRN has been going through the committee roster to figure out who has been favorable to the supplement industry in the past and how they have voted regarding supplements in order to form a strategy. “We are cautiously optimistic we have the votes in committee, if [Blumenthal’s amendment] comes to a vote there."
Still, Mister cautioned whether or not Blumenthal brings the amendment to the committee markup, it is possible he introduces this or even broader dietary supplement-related legislation—such as last year’s Dietary Supplement Labeling Act (DSLA)—on the Senate floor in the next few weeks.
“We can’t be too complacent here," he advised. “This could be the first of several battles that we have to wage."
He said Blumenthal’s approach this year may be due to the election cycle. “NDAA is a “must pass" authorization for the Defense Department, so trying to craft an amend that looks to be specific to armed services is a way to get it onto a bill that will move," he explained, noting standalone legislation that is very broad is not likely to get attention this year with the election. “Most people believe you introduce a bill in May, as Congress will work until July then go home to campaign."
Mister said CRN expects the NDAA markup to conclude this week, but there is no way of knowing what else Blumenthal and his typical allies relative to dietary supplement legislation might have planned before the election season halts congressional progress.
NPA has urged industry members and consumers to speak up for free military access to dietary supplements via an action page.