By Todd Harrison &rnAndrew Bigart01.01.11
One of the biggest stories of 2010 should be Congress’s effort to pass legislation increasing the regulation of dietary supplements and similar products. The first shot was fired in February when Senator John McCain introduced the “Dietary Supplement Safety Act of 2010,” which proposed tough, and many would say, unreasonable provisions regarding adverse event reporting, new dietary ingredients (NDIs) and mandatory recall authority for FDA.
Although the McCain bill stalled in response to strong industry opposition, it remains to be seen—as this issue goes to press—whether Congress will get off a final shot in the form of FDA’s Food Safety Modernization Act (S. 510, the “bill”) before the end of the lame duck session in December. The bill, which addresses food safety generally, includes several controversial provisions that could impact the dietary supplement industry, including facility registration, mandatory FDA recall authority and provisions that require the FDA to promulgate NDI guidance.
What to Expect if the Food Safety Bill Passes
After months of false starts, on November 30, 2010 the Senate passed the bill by a 73-to-25 vote. To expedite passage of the bill during the lame duck session, and to avoid a Conference session, the Senate and House struck an agreement that the House would vote directly on the Senate version of the bill, thus avoiding the need for a conference committee to reconcile the differences between the Senate and House versions.
As mentioned previously, the Senate bill contains several controversial provisions that could directly impact the dietary supplement industry. Many industry experts believe the reforms are unnecessary and that FDA already has sufficient regulatory authority to ensure consumer safety. In this vein, adoption of the bill would substantially expand the scope of regulation and impose undue hardship on the dietary supplement industry without any corresponding gains in safety. Congress, however, seems determined to pass comprehensive food safety reform—whether in 2010 or 2011.
The following summarizes the key provisions that could impact the dietary supplement industry. Importantly, from the dietary supplement perspective, the bill does not include any provisions requiring harmonization with CODEX, or any of the provisions that would have imposed a 10-year jail sentence for certain violations of FDA rules.
New Dietary Ingredients: Perhaps of most interest to the dietary supplement industry, the bill would require FDA, within 180 days of enacting this legislation, to publish guidance that clarifies:
• When a dietary supplement ingredient is an NDI;
• When the manufacturer or distributor of a dietary ingredient or dietary supplement must provide FDA with information concerning the history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe; and
• The evidence needed to document the safety of NDIs, and appropriate methods for establishing the identity of an NDI.
The NDI provision in particular has caused a stir among many in the dietary supplement industry. An aggressive interpretation of the NDI provisions could force notifications for ingredients that have been on the market for years with no reported safety problems, such as probiotics. A few examples of aggressive FDA interpretation include:
• FDA has taken the position that potato protein is an NDI, despite the long history of use of potatoes as food.
• FDA could require an NDI notification for each product containing an ingredient. In other words, every company in the stream of commerce that combined the ingredient with other ingredients would need to submit a new NDI notification.
• FDA has taken the position that affidavits are not sufficient evidence to substantiate prior marketing of a product. Rather, FDA has indicated that companies must provide actual marketing materials.
Mandatory Recall: The bill authorizes FDA to order the mandatory recall of food that has a reasonable probability of being adulterated or misbranded and where exposure would cause serious adverse health consequences or death to humans or animals if the responsible party does not voluntarily recall the food. The wording of this provision represents a small victory for the dietary supplement industry, as a similar provision proposed in the McCain bill would have required mandatory recalls for misbranded supplements, even where there was no risk of serious adverse health consequences.
Biennial Facility Registration: The bill requires each facility engaged in manufacturing, processing, packing or holding of dietary supplements to register with FDA and re-register every two years. The FDA may suspend a facility’s registration if there is a reasonable probability that food from the facility could cause serious adverse health consequences or death to humans or animals, and such suspension may be extended to any facility that created, caused or was otherwise responsible for creating the health risk, or any facility that knew of, or had reason to know of, such risk, and packed, received, or held such food.
Hazard & Risk-Based Preventative Controls: Although the bill requires food facilities to implement hazard analysis and risk-based preventative controls, it also provides that no additional obligations be imposed on dietary supplement facilities already in compliance with the dietary supplement cGMP provisions in the Federal Food, Drug, and Cosmetic Act.
Miscellaneous Provisions: Finally, the bill contains numerous other provisions that could impact the dietary supplement industry, including the requirement that importers establish a foreign supplier verification program, increased FDA authority to access food-related records and test results, and revised standards for food detention, among others.
As We Went to Press…
Just when it looked like the passage of the bill was a done deal, and as this issue went to press, House staffers discovered the Senate bill contained a revenue-raising provision that violates the Constitution’s requirement that all revenue-raising bills originate in the House. The House has sent the bill back to the Senate with instructions to fix it. The Senate, however, has few options for a quick fix—and any modifications to the bill will require unanimous vote. As a side note, Sen. Tom Coburn (R-OK), a noted fiscal hawk, has already stated that he will oppose the bill. Moreover, all 42 of the Senate Republicans have signed a pledge that they will filibuster any legislation during the remainder of the lame duck session that is not directly related to taxes and spending.
Given the number of times the food safety bill has been pronounced dead, it seems pointless to speculate on whether Congress will pass the bill before the end of the lame duck session in December. What is clear, however, is that Congress is keenly interested in food and dietary supplement reform. And whether this year or next, the dietary supplement industry should brace for the possibility of sweeping regulatory changes, touching on many of the core principles included in the food safety bill—especially facility registration, mandatory recall and guidance on NDIs.
