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More FDA Control Does Not Mean More Safety

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More FDA Control Does Not Mean More Safety

News outlets are reporting that the U.S. Food and Drug Administration (FDA) has cited an alarmingly high number of alleged safety and regulatory violations by supplement manufacturers. This may worry some consumers about the safety of their daily multivitamin. It has also prompted some lawmakers to call, once again, for increasing the FDA's control over the supplement industry. While there is no reason to doubt that the FDA found violations of rules in its investigation, more government regulation would do nothing to improve the safety of America's vitamin supply. Here's why.

The Chicago Tribune reported last month ("Dietary supplements: Manufacturing troubles widespread, FDA inspections show") the FDA found violations of good manufacturing practices (GMP) in about half of a total of 450 sites it inspected. Those numbers sound terrible, but as the Council for Responsible Nutrition (CRN) pointed out, they do not tell the whole story. There are at least 1,460 manufacturers of supplements in the U.S. The group investigated by the FDA's Division of Dietary Supplement Programs represents those most likely to be cited for GMP violations in the first place, assuming that the FDA is following its own risk management principles for enforcement priorities. It is quite likely then, that examining the highest-risk manufacturers would yield unusually high rates of violations-"unusual" is the operating word here.

Looking deeper into these numbers, one might ask what these "violations" actually represent. The Tribune story conjured up horrifying images of rat-infested facilities and firms operating without a master recipe.

While some firms did have egregious safety violations, it is likely that a large number of those violations were quite minor, including paperwork violations. Again, according to CRN, the only way the FDA's assertion that half of the facilities they investigated had GMP violations makes sense is if they are counting "notations for voluntary action" as violations. Those are cases in which a violation is so minor that it fails to meet the threshold for even a warning letter, but the firm volunteers to make the desired changes to stay on the agency's good side.

Furthermore, there is a serious conflict of interest regarding the FDA's increase in citations. It is no secret that the FDA desires greater control over the supplements industry. Unlike pharmaceuticals, vitamins and other dietary supplement manufacturers do not require pre-market approval from the FDA, but merely need to register their products and provide reasons why they believe the products are safe.

Last year, the FDA attempted issued draft guidance to the industry that would have resulted in a de-facto pre-approval process. Such a move would have gutted, by administrative fiat, the law that governs supplement regulation, the Dietary Supplement Health and Education Act of 1994. The agency withdrew its guidance in the face of strong opposition from industry, consumers, and the original authors of the 1994 law.

But the FDA may try again, and it has a powerful champion in its quest for more control, Senate Minority Whip Dick Durbin (D-IL). Though his most recent attempt to hand the FDA more power over supplements failed last May, he has seized on the recent media reports to push the FDA's case again. Durbin, along with Senator Richard Blumenthal (D-CT), wrote to the major supplement trade groups asking for their detailed plans for improving conditions at manufacturing facilities. When Durbin submits another proposal to increase the FDA's regulatory hold on the supplement industry, we can expect him to cite the Tribune story as justification. Yet FDA regulation of supplements is unnecessary. It would not enhance safety and would undermine consumer choice.

There is no activity on the planet that is 100 percent risk-free. Bad things happen, mistakes are made, and all of the regulatory oversight in the world will not prevent it. That said, the dietary supplement industry is already covered by the good manufacturing process requirements. If a company violates those requirements, the FDA has full authority to shut down operations and order recalls. If there are mass violations in the industry-which, as noted above, there's no reason to believe is the case-then clearly the FDA is unable to use the power it already has effectively. How would giving it even more control increase safety?

If the FDA were given the power to regulate supplements as it regulates drugs, the only foreseeable outcome is a shortage in dietary supplements (along with increasing prices) similar to the drug shortages our country is currently facing. For example, a recent House Oversight Committee report concluded that a major cause of drug shortages is the FDA's shutting down of an increasing number of pharmaceutical production plants for alleged safety violations. The more than 150 medically essential drugs on the shortage list include critical components for chemotherapy, treatments for atrial fibrillation and heart failure, and drugs used for high blood pressure and heart attacks. The report concluded that the FDA's zero-tolerance policy regarding "good manufacturing practices" resulted in disruptions in production and subsequent drug shortages.

Giving an ineffective government agency more control is not going to improve safety. But there is a better way. One company highlighted in the Tribune article, Consumerlab.com, represents a truly effective way to improve the safety of our nation's dietary supplements. Consumerlab is a private company run by doctors and nutritionists who test over-the-counter supplements for quality and safety and then share their reports for a fee.

More of these consumer-reporting companies, not greater government oversight, will give consumers the information they need to make good decisions about their personal nutrition and health needs.

Moreover, product safety has nothing to do with the notion that anything on a store shelf, whether it's a pill, food, or a product can be 100 percent safe for all of the population. This is and never will be the case. Consumers need to take more responsibility and be more cautious about what they buy. If there was demand for the information provided by companies like Consumerlab, you can bet that there would be many more companies offering this service. As it is now, people believe that the FDA is doing a fine job of keeping consumers safe. By the agency's own admission, we know this is not the case.