At the onset of 2015, for example, New York State Attorney General Eric T. Schneiderman began an investigation into the herbal supplements industry, rallying other state attorneys general and sending letters requesting additional requirements and oversight to be placed on the industry, specifically concerning disclosure of brands being sold by marketers and their products’ ingredients.
Even as recently as the beginning of June, Sens. Richard Blumenthal (D-CT) and Dick Durbin (D-IL) introduced and co-sponsored three amendments to the National Defense Authorization Act for 2016. These amendments—SA 1560, SA 1561, and SA 1562—were put forward with the intention of ensuring quality supplements, removing harmful and illegal supplements, and enhancing the requirement for reporting and recording of military personnel’s dietary supplement usage.
To rally against these amendments and to raise support in Congress against their passage, the Council for Responsible Nutrition (CRN) joined forces with 75 of their members and took to the Hill.
Not Just Another Day on the Hill
On June 17th, CRN gathered its members together for its 12th annual Day on the Hill Event; this year’s was the largest and most formal to date. CRN’s Day on the Hill is a multi-pronged effort designed to increase awareness on the Hill of the dietary supplement industry and anything that pertains to it. This year’s focus was the Blumenthal amendments and educating members of Congress about their perceived negative impact on the industry and military alike, if enacted.
“The amendments called for military personnel to track adverse events regarding dietary supplements, called for service men and women to report their supplement use to military healthcare providers, and limited the sale of dietary supplements in commissary and exchange stores,” stated Mike Greene, vice president of government affairs, CRN.
In CRN’s official press release, Steve Mister, CEO and president, CRN, stated, “[the amendments] duplicate current laws for reporting suspected adverse events from these products; create overly-burdensome monitoring of supplement use by military personnel; and limit access to a wide range of dietary supplements by service men and women.”
To rally support against these amendments, therefore, CRN and 75 of its members, all individuals in executive positions throughout the industry, took to the Hill for their daylong event.
“This is a day of advocacy, a day of lobbying, where members of the industry come to Washington, D.C. and meet with key legislators, both in the House and the Senate,” stated Mr. Greene.
To begin the day, House members addressed the group over light fare and refreshments, while members of the Senate addressed the group in the afternoon. Speakers included Reps. Jason Chaffetz (R-UT), Mike Pompeo (R-KS), Frank Pallone (D-NJ), and Sens. Orrin Hatch (R-UT), Martin Heinrich (D-NM), and John Boozman (R-AR).
Following the briefings by the congressmen, the industry members broke into small groups and proceeded to meet with two or three offices each, speaking with members of Congress and their staff. The offices contacted were chosen, generally, as those that are representative of what Mr. Greene called “committees of jurisdiction.” These are, according to Mr. Greene, committees that have an interest in dietary supplement or FDA-related issues, such as the Energy and Commerce Committee and the Oversight and Government Reform Committee. Also included in the multi-prong outreach, were individual members of Congress who serve on the Dietary Supplement Caucus and had been unable to stop by earlier along with their colleagues to give the group briefing.
At the end of the day, the amendments in question—SA 1560, 1561, and 1562—did not make it into the bill; so overall, the day of activism was a success for CRN and its members. However, the bigger issue still needs to be fought.
“It was imperative the industry react and deal with these as quickly as possible, and this was one of those rare occasions when the industry worked quite well together—all five trade associations were working in unison,” Mr. Greene stated. “It was a well oiled machine that we had going on, but we all recognized that when you go back to the problem of concern, these amendments do nothing to address that.”
The Bigger Picture
Stepping back from the issue concerning proposals for new reporting requirements or increased regulation, Mr. Greene contended that the real issue confronting the industry revolves around FDA and its lack of enforcement capability.
“It was quite clear that these three amendments were duplicative and overly burdensome and, to some degree, unnecessary. None of them would do anything to solve the problems that the industry, Congress, and you read about in the media that everyone is grappling with; that’s more enforcement,” stated Mr. Greene.
Pointing to the Dietary Supplement Health and Education Act (DSHEA) as an example, Mr. Greene elaborated how that landmark law has not yet been fully implemented or enforced, but if it were to be, it would greatly benefit the industry. DSHEA, along with other laws, is not fully enforced and it is allowing the credibility of the industry to be questioned.
In a letter to Attorney General Loretta Lynch, Sens. Hatch and Heinrich called upon Ms. Lynch to utilize the power of her position to align the Department of Justice with the FDA to crack down on those companies and individuals that break the law, but are not currently facing stiff enough punitive actions, sentiments that CRN echoed in a follow-up letter of its own.
According to both letters, during the past six years, more than 400 products have been identified as illegally containing anabolic steroids, or active pharmaceutical ingredients (APIs). These companies were issued a warning letter from the FDA and their product(s) were pulled from the shelves. Though this is standard procedure, it is about the extent of the repercussive action and does little to deter companies from repeating the same behavior with different products.
The senators stated, “The inconsistent use of enforcement actions against the entities the FDA has identified as manufacturers of these illegal products has weakened the deterrent effect of such actions.”
Echoing these sentiments, CRN—in its letter—stated that such actions are “too infrequent and do not effectively remove recidivist firms from the space, which puts public health at risk.”
In alignment with Sens. Hatch and Heinrich, CRN called for DOJ to work with FDA to “put in place a strong deterrence strategy that targets individuals and companies who engage in this blatant criminal activity.”
At the pinnacle of this lack of enforcement, however, is not a lack of will or even necessarily a question of funding, as the prime issue, but according to Mr. Greene, it is more of a lack of leadership within FDA. Though unfortunate, Mr. Greene predicted this will not see resolution until the administration can see that there is in fact a vacuum of leadership and desire to fill this void. This likely will not be addressed until after the next president is sworn in.
In the meantime, CRN is doing what it can to protect the industry and its reputation. “We have to do everything we can to bolster consumer confidence,” Mr. Greene said.
Overall, while there have been recent attempts to increase regulation on the supplement industry, and though they seem to be coming to the forefront at more regular intervals, it is not perceived to be an outright attack on the industry that warrants additional concern.
Commenting on this idea, Mr. Greene noted, “There is a lot of work that we’ve done on the education side, but these issues will always come up. The food industry has issues, the drug industry has issues; I’m not certain that this is abnormal in terms of the activity that’s coming on. It’s important that Congress do its role in scrutinizing the industry so that we can make it better.”
Moving forward, it is essential that efforts be diligently pursued to continue the strengthening of congressional relations and to educate the members of Congress on supplement usage and the health of the industry as a whole.
“We have a great relationship with Congress right now, but that is not going to last forever. No industry is without their critics and we just need to be vigilant and continue to share information with members of Congress, continuing to embrace our friends, but also reach out to those who are suspicious of us, are detractors, and don’t particularly care for the industry,” he said. “This is CRN’s role and we do it well.”
Editor’s Note: CRN’s Annual Conference & Workshop will take place Oct. 21-24 in Palm Springs, CA. For more information: www.crnusa.org/2015events.