The move of the American Herbal Products Association (AHPA) requesting FDA to strictly enforce existing laws against illegal steroid products puts more burden for the agency. During the Senate hearing last month, FDA said that it is a difficult task for the agency to control the proliferation of dietary supplements tainted with steroids. The agency intimates that a new law could solve the problem in the supplements industry. However, the legislators still believes that the current laws are sufficient in confronting the issue. Senator Hatch emphasized that the Dietary Supplement Health & Education Act of 1994 and the Anabolic Steroid Control Act of 2004 are enough to give the FDA and DEA full authority. These agencies are not only tasked to monitor but at the same time to control and can even file criminal charges against companies violating existing laws particularly those entities selling supplement products with illegal or undeclared steroids.

The hearing was attended by the different representatives from the industry. AHPA maintained a strong position on the issue. AHPA President Michael McGuffin said that their organization has long expressed its support for providing adequate resources to ensure that the laws now in place are properly enforced. His statement which was published on their website, ahpa.org, focused on better enforcement of laws rather than creating new laws which will only be disregarded by unscrupulous companies. “Both consumers and law-abiding supplement companies are harmed when scofflaws go unchecked and unpunished, but there is no reason to think that a change in the law would in any way change unlawful behavior,” he said. He also added, “companies that are willing to ignore current laws would also ignore any new law. Enforcement is a better answer.”

The request letter was addressed to Michael Levy and Roberta Wagner of the FDA. Levy is the director of the Division of New Drugs and Labeling Compliance at the Center for Drug Evaluation and Research (CDER) while Wagner is the director of the Office of Compliance at the Center for Food Safety and Applied Nutrition (CFSAN). The letter is urging the FDA to continue the successful enforcement of their program against fraudulent products. They cited the FDA’s successful control of fraudulent 2009 H1N1 products available in the market. If the agency can do this on the H1N1 products, they can also apply it in the illegal steroids products. FDA issued warning letters to companies claiming that their products can used as remedy or treatment for the H1N1 virus. The direct enforcement action by the FDA was lauded by AHPA especially when the agency provided an online list of companies with warning letters. Out of the 136 products on the list, 120 already remove their fraudulent claims.

The Natural Products Insider website also quoted AHPA president Michael McGuffin’s concern about the FDA’s capability in curtailing the problem, “AHPA is concerned that the net impression left by FDA’s testimony before the Senate is that the agency cannot presently take effective enforcement action with respect to synthetic steroids that are illegally marketed as dietary supplements,” he said. “AHPA disagrees, and believes that FDA has all of the authority it needs to shut down the marketers of any such product. We are today suggesting that the agency can do so efficiently by adapting its successful program for enforcing against fraudulent H1N1 products,” McGuffin added.

The AHPA believes that the FDA can do its job efficiently since during the senate hearing, the FDA testified that they could identify “several possible enforcement outcomes” against any product that contains a synthetic steroid.

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