02.26.10
In response to the recently proposed McCain bill, the law firm Venable LLP, Washington, D.C., has decided to form an industry coalition to monitor and advocate regarding certain legislative proposals.
According to Venable, the coalition will be comprised of a diverse group of companies representing a broad cross-section of the industry that have a significant stake in production, manufacturing and marketing of dietary supplements. In addition, companies or firms that sell, market or service dietary supplements as a principal line of business would be considered for coalition membership.
Earlier this month, Senator McCain (R-AZ) held a press conference and introduced the Dietary Supplement Safety Act of 2010 (S.3002) (“DSSA”). According to industry experts, the proposed legislation would impose significant administrative and compliance requirements on the dietary supplement industry.
Of most concern are: (1) Under the DSSA, dietary ingredients in circulation prior to 1994 would no longer be grandfathered. In other words, all supplements would be presumed unlawful unless and until the FDA Commissioner says otherwise. (2) Currently, a dietary supplement containing a new dietary ingredient will not be adulterated if the dietary ingredient has been present in the food supply as an article used for food and has not been chemically altered. The DSSA removes the exception, making it more difficult for new dietary ingredients to be introduced into the market. (3) The DSSA requires reporting of all adverse events, whether serious or not, to FDA.
Currently, the legislation is pending before the Senate Health, Education, Labor and Pensions Committee. In discussions with committee staff, Todd Harrison, partner, Venable, says it has been determined that Sen. McCain intends to aggressively push for consideration of his bill as soon as possible during this session of Congress.
Venable believes the issue is seen as a non-partisan concern and, thus, could encounter little opposition—unless stakeholders opposed to the broad application of the legislation to the supplement industry quickly engage and educate Members of Congress and their staffs. Although there is no companion bill for S.3002 in the House of Representatives, the Chairman of the Energy and Commerce Committee (Henry Waxman, D-CA) is known to be critical of the supplement industry and could easily turn his attention to the McCain proposal. It is important that stakeholders also engage the House at this time—ideally, before a companion bill is introduced.
On Monday, March 1, Venable will hold a conference call for all interested parties. The conference call will begin at 4:00 p.m. EST (3:00 p.m. CST/2:00 p.m. MST/1:00 p.m. PST) and the call in number is 866-740-1260—use code: 3444724.
This call will last no more than one hour and will enable the firm to walk-through for companies where the legislation stands, what the likely chances are for action on the bill this year, and provide a means for consideration of next steps for the coalition.
