Now that Senators Hatch and Harkin, with more than a little bit of help from a strong grass roots reaction, have persuaded Senator McCain to pull back from his overbroad/misguided effort to eliminate steroids from dietary supplements by effectively requiring FDA pre-approval of all supplements, you might think that there's time to take a breather for everyone to congratulate themselves on a "job well done." The problem is that if you did this, you'd be very wrong. There are two issues pending in Congress right now that warrant your immediate attention.
The first has to do with the Federal Trade Commission Reauthorization tucked away in H.R. 4173, the Wall Street Reform and Consumer Protection Act of 2009. Buried in this massive piece of legislation is a provision that would amend the Federal Trade Commission Act by removing existing procedural safeguards on the rulemaking and enforcement capabilities of the Federal Trade Commission ("FTC" or "Commission"). Make no mistake about it, this is a matter of serious concern that has the potential to severely restrict the way dietary supplements (and many other consumer goods and services) are marketed. Under H.R. 4173, the FTC would no longer be required to seek Congressional approval before undertaking formal rulemaking procedures.
This procedural safeguard was instituted in the early 1980s following FTC abuses of APA rulemaking procedures in the 1970s, when the Commission attempted to regulate children's advertising, lawyer's fees, advertising by physicians, ready-to-eat breakfast cereals, auto manufacturers, hearing aids, mobile homes and over-the-counter drugs. Removal of this protection would permit the FTC to promulgate regulations affecting any kind of advertising, including dietary supplements. This could easily lead to a major sea change in how the supplement industry is able to communicate with consumers. To illustrate:
Today when the FTC challenges advertising claims for a dietary supplement product on the basis that the advertiser does not have gold standard (long-term, randomized, placebo controlled, cross-over, multi-center) studies on the specific product in question, in order to prevail the Commission must first convince a Federal Judge that there is no basis for relying on ingredient based substantiation.
If H.R. 4173 is enacted into law without change, the FTC would simply be able to promulgate a regulation that requires any performance claim for any dietary supplement to be substantiated by two gold standard studies on that specific product. Supplement companies would not be able to rely on ingredient based substantiation.
H.R. 4173 has already passed the House of Representatives. Financial reform legislation is currently before the Senate. Representatives of the Natural Products Association, American Herbal Products Association and the Council for Responsible Nutrition are already working with Senators Hatch and Harkin to address this concern. It is also important that your Senators hear from you on this issue. The Direct Marketing Association has set up an excellent webpage explaining the importance of ensuring that common sense restraints remain in place at the FTC and telling you how to communicate with your elected officials on this important issue.
The second issue of immediate concern relates to the Food Safety Enhancement Act of 2009, H.R. 2749, which passed the House on July 30, 2009. This bill would impose a regime of Hazard Analysis & Critical Control Points (HACCP) on all food facilities in the United States. This change in existing law is ostensibly designed to upgrade weak Good Manufacturing Practices (GMPs) in place for food producers. The problem is that H.R. 2749 does not recognize that as of this June, every dietary supplement manufacturer in the United States will be operating under the new, rigorous, dietary supplement GMPs. This creates the significant risk that FDA will determine that since dietary supplements are a subcategory of food, supplement manufacturers will have to scrap their newly implemented (at great cost) GMPs and adopt (at great cost) a HACCP program.
Fortunately, once again Senators Harkin and Hatch in conjunction with AHPA, CRN and NPA have stepped into the fray and ensured that the Senate version of this food safety legislation, S.510, specifies that the new HACCP requirements do not apply to dietary supplement manufacturers.
The challenge on this issue will now apparently take place when Senate and House negotiators get together to iron out the differences in the bills passed by each House. When this occurs we will need a strong voice from the House of Representatives to speak for the supplement industry. On Monday April 26, at SupplySide East, Jon Benninger, Michael McGuffin and I will be hosting a fundraiser/reception for Representative Frank Pallone, one of the original sponsors of DSHEA and a long time champion of the supplement industry. I urge you to consider contacting me for information on attending this reception so that you can tell Rep. Pallone just how important it is to your business for the Senate language ensuring that HACCP is not applied to your business prevails. If you'd like information on attending this event, please let me know. If you cannot attend but would like to show your support for Rep. Pallone, please contact me and we can discuss how to do this.