By Len Monheit
The dietary supplements industry received at least two blows this week, and many probably never saw either one coming.
The first occurred with the passage of the National Uniformity for Food Act (H.R. 4167) by a vote of 238 to 139 in the House, a bill that would generally prohibit individual states from requiring food products in interstate trade to conform to state regulations or labeling rules that are not identical to federal provisions. Since dietary supplements in the United States are regulated as foods, the law presumably covers them as well, right?
An amendment to the bill, introduced by the Chair of the Commerce Committee Congressman Joe Barton (R-TX) revised the exclusion section of the original bill so that the proposed law would have no effect on dietary supplements. While the bill still has to go to the Senate, the revision points out the fact that certain beliefs and perceptions are extremely strong, including those that believe that supplements pose a health and safety risk. As it turns out, effective Serious Adverse Event Reporting legislation, and the results the legislation produces will eventually help alter this argument. In the meantime, industry must understand the powerful forces that continue to believe it is not responsible and indeed almost unmanageable.
The second incident was the issuing, by the Food and Drug Administration (FDA), of several warning letters and a press release about unapproved new drugs, containing steroids and marketed as dietary supplements, and the Agencyâs intent to enforce on this issue. Industry and the sports community have both called for a stepping up of these types of action and the initial letters issued by the FDA to four companies involved indicate (presumably) that there is hope that manufacturers who prepare products masquerading as supplements will be dealt with under the power of law. The products are illegal, FDA communications establishes them as such, and the messaging to all should be quite clear, right?
This time the media either didnât get it or deliberately chose not to get it. With ringing headlines like âFDA Issues Warning on Dietary Supplementsâ and Dietary supplements deemed illegal by FDAâ an Associated Press article almost totally ignores the fact that the products in question are not supplements. The coverage and pickup continues to associate and imply blame on the supplements industry and this is a perspective that we seem unable to adequately change. Secondary pickup in smaller media outlets actually goes on to say that the problem lies with DSHEA.
While singly, these two issues probably donât damage the industry from a credibility or monetary standpoint (the damage was done long ago), they continue to anchor existing beliefs and sway legislators, and they also undermine and steal headlines from the many positive things going on.
For instance, earlier this week, NSF International announced the launch of a new athletic banned substances certification program for dietary supplements and sports nutrition products, a program that not only will be followed, but will be recommended by key athletic organizations, including Major League Baseball, the Major League Baseball Players Association, and in the near future, the Canadian Centre for Ethics in Sport.
It is through this type of outreach and dialogue outside the industry that bridges can be built and some of the fundamental negative perceptions at least challenged.
Active support of and working with legislators to ensure that final Serious Adverse Event legislation is appropriate is another example of being proactive that can only help industryâs position. Participation in development of analytical methods is yet another.
While the events of the past few days might have caught some by surprise, they fundamentally should not be a surprise. Planning effectively involves understanding the opposition, in some cases, better than the opposition understands themselves.