The First Shoe Has Dropped on Dietary Supplements

We predicted late last year before, during and after the election that 2009 would begin a time of change and challenge for dietary supplements. It looks like the first shoe has dropped: The U.S. Government Accountability Office (GAO) presented a report to Congress last week, titled Dietary Supplements: FDA Should Take Further Action to Improve Oversight and Consumer Understanding.

A link to the full 70+ page report appears at the end of this article. Here are a few highlights:

1. The Players

The GAO is known as "the investigative arm of Congress." It's self-described mission is to improve the performance and ensure the accountability of the federal government. Typically, its work is performed at the direction of Congressional Committees. Its work "leads to laws and acts that improve government operations."

With regard to this particular report, the GAO's work was done at the request of Congressional Representatives Henry Waxman, John Dingell and Bart Stupak, and Senator Richard Durbin. Rep. Stupak has been one of the FDA's most vocal critics, as we reported some weeks ago. As we have also reported in the past, Reps. Waxman and Dingell, and Sen. Durbin have been skeptics - if not outright critics - of DSHEA and the dietary supplement industry for years.

2. The Issues

The GAO organized its comments according to four themes:

• The FDA has insufficient information from the industry about dietary supplements and manufacturing operations to be effective.

• The FDA has applied insufficient resources to properly oversee dietary supplements.

• The FDA has insufficient authority to remove products from the market.

• The FDA needs to do more to educate the public about dietary supplements.

3. GAO Comments of Concern

Within the GAO Report, we find these comments:

"According to several experts we spoke with, [the FDA's] regulatory approach [to supplements under DSHEA] has fallen short in protecting U.S. consumers in the past."

Among other things about this statement, we would like to know who these purported experts are, and the methods they used to arrive at their conclusion. We would also like clarification: is it the FDA or the law itself that has failed the public?

"[Even though reported adverse events average about 500 per year], the FDA recently estimated that the actual number of total adverse events . . . related to dietary supplements per year is over 50,000 . . ."

We would very much like to know how the FDA arrived at this estimate, including how the FDA evaluates whether an adverse event was actually caused by supplements as opposed to other potential causes. We also point out that the average adverse events reported for pharmaceuticals each year for the past 5 years is over 300,000.

4. GAO Recommendations

The GAO made four recommendations

• Dietary supplement companies should be required to identify themselves as a dietary supplement company as part of the existing registration requirements, and they should be required to update this information annually; they should be required to provide a list of the products they sell and a copy of the labels, updated annually; and they should be required to report all adverse events related to dietary supplements, not just major events.

• The FDA should issue guidance to clarify when an ingredient is considered a new dietary ingredient, the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing ingredient identity.

• The FDA should provide guidance to industry to clarify when products should be marketed as either dietary supplements or conventional foods formulated with added dietary ingredients.

• The FDA should work better to educate consumers about the safety, efficacy, and labeling of dietary supplements.

Note that the GAO made no specific recommendations about changing outright the regulation of dietary supplements under DSHEA. But you can bet this report isn't the last shoe to land.

We'll have more in the coming weeks about the GAO report and the recommendations. In the meantime, you can read the report for yourself at: http://www.gao.gov/new.items/d09250.pdf