Inside Washington

Former chief of staff for Tom Harkin offers insight into lawmakers’ thinking regarding dietary supplements.

By
Rebecca Wright
Editor

As Congress continues to debate the progress of the war in Iraq and expanding healthcare coverage for children, dietary supplement issues continue to fall lower on the priority list for many lawmakers. This was the opinion expressed by Peter Reinecke, former chief of staff for Tom Harkin (D-IA), who spoke at a mid-September GMP seminar organized by the United Natural Products Alliance (UNPA), Salt Lake City, UT. Of course, this doesn’t mean no one is paying attention. Indeed Mr. Reinecke emphasized that while dietary supplements may not be priority No. 1, Congress still continues to keep an eye on the industry through various developments.

Currently the dietary supplement industry has two major issues on the table: serious adverse event reporting (AER) legislation, which becomes law in December, and the implementation of good manufacturing practices (GMPs) regulations for dietary supplements. Unfortunately, Mr. Reinecke said, partisanship continues to slow progress on many fronts, with no one knowing whether there will be compromise or conflict between the White House and Democrats in the months ahead.

With respect to AER legislation companies are still waiting for FDA to issue a guidance, especially to clear up specific issues like labeling. Companies are still not clear as to what type of information needs to be printed on the label. Some experts speculate that labeling changes may even go as far as requiring a specific mailing address, PO Box, or even an email address. If that’s the case, companies will have to make some significant changes—an issue that has companies worried about costs of printing, as well as time and effort required to make changes. (As this article went to press, FDA had finally issued a guidance, which can be accessed at http://www.cfsan.fda.gov/~dms/dsaergui.html.)

On the bright side, it is more than likely that bill S. 770, introduced by Senators Orrin Hatch (R-UT) and Tom Harkin, will allow the purchase of supplements with food stamps. According to Mr. Reinecke, this could be a major development because it will recognize that supplements play a prominent role in supporting good health.

In an effort to stem the backlash against FDA regarding its oversight of food, supplements, pet food and drugs, both the House and Senate passed bills to significantly boost FDA’s budget. The House bill provides $121 million—the largest boost in years—which gives FDA a total budget of $1.7 billion. The Senate, on the other hand, passed a bill that provides a $186 million boost. Whatever amount FDA winds up with, Mr. Reinecke said $1.5 million is supposed to be set aside to implement the AER law.

In other developments, the General Accounting Office (GAO), Congress’ investigation arm, has been requested by Reps. John Dingell (D-MI) and Henry Waxman (D-CA) to evaluate the adequacy of DSHEA (the Dietary Supplement Health & Education Act), supplement labeling and the new AER law. Mr. Reinecke said the report would probably be completed in the Spring of 2008, with hearings and legislation likely to follow. The reason? Both Mr. Dingell and Mr. Waxman say they want to make sure there is enough funding to protect consumers.

Since the pet food recall in March, the safety of the food supply has become a hot button issue, triggering hearings, investigations and legislation, which will only escalate in the coming months. Although supplements won’t be the main focus, they will not be ignored.

The Import Safety Commission is the brainchild of the executive branch. The commission, to be chaired by Mike Leavitt, will recommend changes to improve the safety of imports (including supplements). It has been largely recognized that the U.S. cannot inspect its way to a safer food supply. Therefore, most are providing thoughts and suggestions regarding a more preventive approach.

In the House, Rep. Dingell has set food safety as his top priority for his committee—The Committee on Energy and Commerce. The committee is supposed to hold hearings through October, with legislation expected to move into committee by November. Among other things, Rep. Dingell wants to make sure foods are held to U.S. safety standards or greater, and that FDA imposes a user fee to cover inspection costs. There would also be a requirement for “country of origin” labeling. (For more information on food safety, see the October 3rd Online Exclusive: Courting Disaster – Part II.)

Over in the Senate, Richard Durbin (D-IL) has already moved on the food safety issue by proposing an amendment that sets up a system for reporting adulterated food and giving the government mandatory recall authority—dietary supplements will likely be exempted. S. 1776, the “Imported Food Security Act,” introduced by Senators Durbin and Brown, provides similar provisions to the Dingell bill, with user fees and international standards the highlights. So far, no hearings or other actions are scheduled, but a floor amendment is possible.

So how will all of this impact the dietary supplement industry? Mr. Reinecke believes Congress will more than likely pass substantial legislation by next year. While dietary supplements may not be the main focus, they will probably be impacted in some way. Some of the key issues to think about, he said, are country of origin labeling, coordination with GMPs, and user fees. Mr. Reinecke also urged the industry to do everything in its power to assure Congress that the current legislative framework is adequate for dietary supplements and work intensely to implement AER legislation and GMP regulations.

Something sure to annoy FDA, Mr. Reinecke said, is companies claiming to be “GMP Certified” or “FDA GMP Approved.” He said companies that choose to use these tactics in marketing and promotions will undermine all of the work that has been done on the part of the supplement industry. So will the next election usher in major changes for the dietary supplement industry? Mr. Reinecke said only that the industry is more likely to see an aggressive FDA under a democratic administration.