EDITORIAL

FTC Power Expansion Rejected

C ould the nutritional supplement industry survive if it had to prove all health claims made about its products, including even those that are only implied? The Dietary Supplement Health and Education Act of 1994 (DSHEA)—passed unanimously by Congress—doesn’t require that type of omniscience, the requirement of which is likely to cause bankruptcy for the entire industry. But that hasn’t prevented some members of Congress to try to get around the limitations that DSHEA has placed on them.

The principal idea of DSHEA was that supplements should be treated like food, and not like drugs. Yet members of the regulatory class—people like Congressmen Henry Waxman (D, CA) and Barney Frank (D, MA), and Senator John McCain (R, AZ)—are forever looking for ways to “protect” the American public, even if the cost of that protection is so great that nutritional supplements disappear.

Just last week, (June 25, 2010) in an all-night session in Washington D.C., a last-ditch effort was made to save a Federal Trade Commission (FTC) power expansion provision inserted into the Wall Street Reform and Consumer Protection Act of 2009 (H.R. 4173). What does the FTC have to do with a financial bill? The deliberations of a conference committee went until the wee hours of the morning. Its goal was to resolve the differences between the House and Senate versions of the Act, only one of which contained the power-expansion amendment. Fortunately, the FTC provision was rejected and therefore won’t be in the bill that is submitted for voting in both the House and Senate, before it winds up in the Oval Office for the President’s signature.

Making Its Own Laws

Based on its prior actions, the FTC would have used the expanded powers to make its own laws that target dietary supplement companies and restrict access to supplements. That is what regulatory agencies can normally do. It’s called “rule-making.” Last March, a Government Accountability Office (GAO) report identified factors limiting FDA’s ability to “protect” consumers from unsafe dietary supplements. About this, Congressman Waxman said, “I am troubled that the FDA lacks the basic information necessary to protect consumers from unsafe dietary supplements. … The FDA clearly needs to have more resources to give consumers real protection. I intend to work with my colleagues in Congress to ensure that FDA has the tools it needs to address this and other important public health missions.”

Safety at Any Cost

Whatever the criticisms, American food is safe, among the safest in the world. American nutritional supplements are equally safe. There was not even one death caused by a vitamin or dietary mineral in 2007, as per the most recent statistics available from the U.S. National Poison Data System.1 The 132-page annual report of the American Association of Poison Control Centers published in the journal Clinical Toxicology shows zero deaths from multiple vitamins; zero deaths from any of the B vitamins; zero deaths from vitamins A, C, D, or E; and zero deaths from any other vitamin. That’s pretty safe.

Nevertheless, just this year an attempt was made by Senator McCain to overturn some of the major provisions of DSHEA—amazingly, he called his bill the Dietary Supplement Safety Act of 2010. Fortunately, it was withdrawn as a result of its high unpopularity, so what is a serious “safety” regulator to do? Directly attacking supplements would take the form of an amendment to DSHEA, since that legislation governs FDA regulation of supplements. Why not circumvent Congress entirely, by giving the FTC important new powers that could be used to circumvent key supplement protections in DSHEA? That’s the path chosen by the regulatory cognoscenti.

Is It Commercial Fraud or Simply the Truth?

The chief mission of the FTC is to combat commercial fraud. For this, it has been given full authority to pursue companies that make fraudulent claims. But they can’t go beyond that, by creating other regulatory requirements, without advance Congressional approval. It is interesting to note that the FTC once had rule-making authority, but it lost it in the 1980’s because Congress thought the Agency was abusing it.

In the present, when the FTC moves against a dietary supplement company for false or misleading advertising, the FTC typically requires the company, as part of a “consent decree” agreed to by both parties, to back up its claims by undertaking at least two random controlled human trials. Currently, this is done on a case-by-case basis and is deemed legal because the targeted company has agreed to it. However, if the FTC had general rule-making authority, we could expect the worst, if not all at once, then eventually.

What is the harm if supplement companies were required to perform two random controlled human trials for each product? It would create a precedent. The cost would be enormous, well beyond the financial means of all but a few supplement companies, and those would probably be limited to just a few products. A company with 100 products would have to do 200 trials.

For the few companies that could afford it, what would prevent the FTC from constantly requiring more costly versions of these studies, or more of them? This slippery slope would drive the entire industry, or what’s left of it, into the same model used by pharmaceutical companies, ultimately reducing the variety and number of supplements and driving their cost into the stratosphere.

Furthermore, aside from who could, who would pour billions into these studies if they couldn’t patent the nutrients? You can’t patent what exists in nature. At the end of this ordeal, nutrients would have to become drugs, in name if not in actuality, much as it is in Europe. But isn’t this what the regulators want?

Regulators Preferences Match Those of the Drug Companies

Of course, drug companies would like this, because supplement companies are their competitors. So if they ended up with supplements as drugs, as part of the drug industry, that would only add to their profits because supplements are generally more effective and less toxic than drugs.

Speak to a nutritional supplement regulatory lawyer and ask if there is something special about the FTC that we should know about. Chances are the he or she will tell you that the FTC routinely targets nutritional supplement companies for telling the truth about their products. The lawyer may also tell you that some companies are threatened merely by linking to published scientific studies about ingredients in their products.

Even without the increased powers, when the FTC currently targets a particular company that’s having success in the natural products marketplace, they typically accuse that company of “inferring” some health benefit. Then the FTC demands that the company engage in paying a massive fine to the FTC, which the FTC calls “consumer redress.” And of course, none of the money ever goes to the consumers.

Try to fight the FTC, and they drag you into their own special “FTC courts.” These are not public courts where you have the benefit of a jury, but rather they are courts where the judges are actually FTC employees and you have no rights. Reversing the time honored “innocent until proven guilty,” virtually no one has ever been found innocent by the FTC. It’s merely a matter of how guilty you’re found to be.

The FTC may also force you to sign a “consent decree,” the admission of committing crimes that you may have never committed. Included in these crimes is the “criminal misrepresentation of a product,” such as stating that fish oil can help prevent heart disease.

Using these methods, the FTC’s “winnings” amount to as much as tens of millions of dollars from nutritional supplement companies. At the same time, its tactics have put several companies out of business, while denying the American public access to products that could improve their health and prevent disease.

More Power to the FTC?

Make no mistake: we have not seen the end of this attempt to allow the FTC to completely circumvent DSHEA. The latest maneuver was thwarted by an aroused nutritional community, leery of those who want to “protect” us at unacceptable expenses, to our pocketbooks and as well to our liberty. “They that can give up essential liberty to obtain a little temporary safety deserve neither liberty nor safety.” So wrote Benjamin Franklin in his 1759 volume, Historical Review of Pennsylvania. We won’t buy into that. The work that we do is too important.

References

  1. Bronstein AC, Spyker DA, Cantilena LR Jr, Green JL, Rumack BH, Heard SE; American Association of Poison Control Centers. 2007 Annual Report of the American Association of Poison Control Centers’ National Poison Data System (NPDS): 25th Annual Report. Clin Toxicol (Phila) 2008 Dec;46(10):927-1057.

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