New York, NY—The American Conference Institute (ACI) in collaboration with the Council for Responsible Nutrition (CRN) hosted a sold-out program at the third annual “Legal, Regulatory and Compliance Forum on Dietary Supplements” in New York City, June 24–25.

The forum zeroed in on several hot-button regulatory and legal issues currently affecting the industry. Steve Mister, president and CEO of CRN, began the program with an overview of these issues and explanation of why he feels, “We are a vulnerable industry for a number of reasons.”

Soft spots. Mister’s “Dietary Supplements and the State of the Union” began with the recent actions by NY Attorney General Eric Schneiderman. After tenuous DNA barcoding analysis of herbal supplements turned up allegedly suspicious results, he sent four major retailers cease-and-desist letters for their sale. Schneiderman also launched an investigation into several manufacturers and mobilized other AGs to investigate the industry. Said Mister of the situation, “It has tenderized this industry in a way that many other events have not. It’s being talked about among lots of different groups like the consumers, suppliers and others.”

Mister said the NYAG’s actions have “wounded industry and others will want to pile on.” For instance, he brought up the HBO Real Sports segment questioning supplement safety implying a political connection.

Also “piling up” are the many negative media reports, which Mister fears create vulnerability for the industry.

He also referenced the recent Congressional hearing on weight-loss supplements, at which Mehmet Oz, M.D., testified. The legitimacy of and science behind these products were called into question. “It was not a good day for the supplements industry,” said Mister.

Meanwhile, supplements-supporter Senator Tom Harkin retired from Congress, creating an opportunity for antagonists to create mischief. The good news, said Mister, is that the Congressional Dietary Supplement Caucus has grown recently and more and more lawmakers are interested in supporting the supplements industry. Mister added, “We are entering a new reality where you may not have one Republican and one Democratic champion, but you have a lot of situational allies."

Other good news is that the number of committed supplement users is beginning to grow. Industry is still susceptible among shoppers that are considering jumping into the category, but hesitate because of a misleading media report or political action like that of the NYAG.

What industry faces today. Mister brought up several key political issues that industry is currently facing. First, he referenced the National Defense Authorization Act to which Senators Richard Blumenthal and Dick Durbin attempted to tack on amendments that would have restricted the sale of dietary supplements on military bases. In the end, the amendments weren’t put in and won’t come to a vote. This is not the only way Durbin is attempting to stifle the supplements industry. Mister fully expects Durbin to propose an updated Dietary Supplements Labeling Act, as he has done in previous years. He has also cosponsored legislation to establish a new centralized food agency, breaking apart the regulatory agencies we know today.

Additionally, Senator Claire McCaskill has started questioning retailers about the sale of memory supplements that she believes are making false and inaccurate claims.

Legislation is also being considered regarding genetically modified organisms (GMOs). One (the Pompeo Bill) is calling for voluntary labeling of non-GM with a national standard for non-GM and would pre-empt state standards. Since Vermont's bill will soon require mandatory labeling, this bill is under a lot of pressure to move forward into the Senate, a step Representative Mike Pompeo is hoping to have happen before the end of the summer.

A potentially positive area for supplements could be the inclusion of their reimbursement without prescription through flexible spending accounts.

DSHEA rewrite? Mister also raised the question of whether it’s time to consider rewriting the Dietary Supplement Health and Education Act (DSHEA) of 1994. What would we ask for? Are there things we’d have to give away? Industry may want to start thinking about these questions.

Top regulatory issues. Industry should also be concerned that “FDA is not showing strong leadership these days when it comes to supplements,” Mister stated. With more than five interim leaders for supplements and the Center director recusing herself of supplements issues, FDA is not expected to make any big moves like releasing an updated NDI guidance until there is more permanent leadership.

He also stated that a concern for responsible companies doing the right thing is when serious GMP violations are found among illegitimate players and a simply warning letter is given without additional action. Mister stated this is the "worst place for industry to be."

There is also talk of raising the supplements program from a division to an office level, which may provide more resources for FDA enforcement.

Regarding the Federal Trade Commission (FTC), industry should be following what’s going on with the Bayer (Phillips Colon Health) case. Are appropriate experts selected to testify on behalf of the FTC? How is FTC truly judging the evidence backing structure–function claims?

Moving forward. Mister stated that all these issues are "creating a perfect storm for some vulnerability and perhaps some changes in the industry."

The best way to respond, he feels, is careful monitoring and proactive responses, and that the trade associations play a critical role in those efforts.

Published in WholeFoods Magazine, August 2015 (online 6/30/2015).