FDA Attempting to Regulate Dietary Supplements

FDA Attempting to Regulate Dietary Supplements

July 7th, 2011 // 12:33 pm @

Source: Pharmalot.com

The Food and Drug Administration has taken hits over their lack of regulation for dietary supplements, but are taking steps to rein in the booming industry in an attempt to safeguard consumers.

The FDA regulates dietary supplements under a different set of regulations than those covering conventional foods and drug products (prescription and over-the-counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), dietary supplement manufacturers are responsible for ensuring that a dietary supplement is safe before it is marketed. The FDA has only been responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.

The brouhaha over Hydroxycut and its adverse health effects is one example of how the regulations fell short. The diet supplement, which listed appetite control, weight loss, and improved energy among its positive effects, came under fire from the FDA after it received reports of adverse health effects, including one death and one person who required a liver transplant. Other problems reported included heart problems and a type of muscle damage that could lead to kidney failure. The FDA finally stepped in and warned consumers to stop using the popular line of weight loss products.

While the dietary supplement industry believes that current regulations are adequate to protect consumers because manufacturers conduct their own safety tests, this is not always the case. Rigorous testing providing safety and effectiveness data, which is required of all drugs, is not conducted in the same way for dietary supplements. And therein lies the problem.

Consumer products researcher, Consumer Reports, has conducted their own studies on protein drinks and issued a warning about the amount of protein and lead contaminants found in these popular beverages. The testing consisted of 15 protein drinks and Consumer Reports found that all the products had at least one sample containing one or more of the following detrimental ingredients: arsenic, cadmium, lead, and mercury. In some cases, the amount of lead in a single daily serving of eight of the products exceeded California Proposition 65 levels, which would require warning labels.

Subsequent to the study, Consumers Reports issued a statement that it “believes that the FDA’s oversight under the Dietary Supplement Health and Education Act is inadequate to ensure that protein drinks and other dietary supplements are consistently low in heavy metals and other contaminants. … [More] must be done to ensure that those products are properly evaluated for safety and effectiveness before they are sold to consumers.”

In response to recent pressures, the FDA has today issued a draft of a guidance document for the dietary supplements industry stipulating that manufacturers must notify the agency in advance when adding a “new ingredient” with an unknown safety profile to their products. The manufacturers must also provide evidence that the ingredient is safe for consumers. They consider this “an important preventive control to ensure that consumers are not exposed to unnecessary public health risks from new ingredients with unknown safety profiles.”

The term “new dietary ingredient” means a dietary ingredient that was not marketed in the United States in a dietary supplement before October 15, 1994. There is no authoritative list of dietary ingredients that were marketed in dietary supplements before October 15, 1994. Therefore, manufacturers and distributors (you) are responsible for determining if an ingredient is a “new dietary ingredient” and, if not, for documenting that a dietary supplement that contained the dietary ingredient was marketed before October 15, 1994.

While this is a step forward in ensuring public safety, many believe that more rigorous testing should be required of dietary supplements, and that approval for new products should undergo review prior to landing on store shelves for public availability.

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