Actually, all of these items were predictable to some extent as the early signals of these events (or in the case of the NDI guidance, the lack of an event) were evident long before they occurred. Serious questions about ingredient identity and supply chain integrity have been raised about dietary supplements for years; it was just a matter of time until a law enforcement agency cracked down. Unfortunately, the New York AG was misdirected and misused DNA testing, but public allegations of adulteration should have surprised few.
Senator Durbin’s efforts to hijack unrelated legislation with amendments that would impose burdensome requirements of supplements is nothing new either—that’s why the industry was ready for him and quickly fought off those proposals that would have inappropriately limited supplement access by military personnel.
Even the recent internal changes at FDA have been in the works for some time. CRN and the other industry associations publicly called on FDA last spring to raise the visibility of dietary supplement regulation at the agency with a new office and have been pressing for tougher enforcement for several years. The absence of a new NDI guidance is hardly a surprise either given the internal restructuring in process and the absence of a permanent director of dietary supplement programs. But once the dust settles on the new Office, keep watching in 2016…
That is not to suggest that unexpected surprises don’t occur; rather, by carefully watching the tea leaves and planning for these contingencies, the industry can be well-prepared when these events do occur. At CRN, here are some things we are doing in 2016 to be ready:
Following CRN’s annual conference, our Board of Directors directed CRN staff to move forward with recommendations that would help provide FDA with the transparency it needs to better understand what dietary supplement products are on the market. CRN will soon be announcing the first step in its plan to provide regulators with access to these labels to help regulators and researchers alike have a clearer understanding and appreciation for the full industry landscape.
CRN is continuing to evaluate additional strategies to increase the visibility of our members’ products for their customers as well, so stay tuned for more in 2016. Several proposals are being evaluated by our member task force that would give retailers and consumers greater ability to see ingredient supply chains, confirm the product was manufactured according to GMPs, learn about third party certifications for the product and get assurance that the label has been made available to FDA as well. These initiatives will demonstrate to our critics that CRN members stand behind the quality of their products.
CRN is strengthening our efforts with the state attorneys general as well. We are a member of the National Association of Attorneys General (NAAG), and both the Republican and Democratic AG associations (RAGA and DAGA), which allows us to attend their meetings and interact with these officials, providing education and perspective on the industry. In fact, one of CRN’s staff appeared on a panel representing the industry at a NAAG consumer protection conference this fall. In addition, CRN has conducted over 15 meetings with particular state AGs who have expressed interest in these products. These relationships will permit CRN to share information with these officials about the federal regulation of supplements and serve as the industry source to answer their questions. We even held a webinar last month for our members on how companies should interact with their state AGs in advance of a potential investigation.
Senator Durbin has already “tipped his hand” that a new version of his dietary supplement legislation to amend DSHEA is in the works. There may be some aspects of his bill that industry would agree with—there is widespread consensus that FDA needs more resources and authority to prosecute bad actors and companies that market illegal pharmaceutical ingredients as supplements or operate with complete disregard for GMPs. On other issues, CRN is prepared to stand firm to protect the industry, and our members are strengthening their ties with members of Congress who share our concerns for burdensome regulation that doesn’t provide real assurances of safety to consumers. Our annual “Day on the Hill” in June gives CRN members the opportunity to have a meaningful dialogue with over 50 Senators and Congressmen. CRN’s PAC, the largest association PAC in the industry, continues to grow and provide new opportunities for access and relationships.
Don’t forget the state legislatures either. CRN’s monitoring operation is tracking all 50 states and closely watching bills in at least six states that could negatively impact dietary supplements. In addition to state-based alliances and grassroots activities, we have local lobbyists in the capitols of several states watching for mischief even before it occurs.
So yes, 2016 will be unpredictable. But just like the Boy Scouts, our motto must be to “Be Prepared.” What is your company doing to defend itself against the unexpected? And how can CRN help?