DIETARY SUPPLEMENTS: RECALLS & BANS 101
For a consumer, a press release of a recall or ban of a product is thought to be in real time, when in fact some perceived “recalls” or “bans” have been years in the making. Another not well known fact is that a perceived recall or ban may be neither. Most of the dietary supplement industry stated in the January 09 GAO Report “the FDA must demonstrate that the dietary supplement presents a significant or unreasonable risk, or is otherwise adulterated before it can be removed from the market.” As we have seen in the recent past, “while the FDA was successful in 2004 in banning Ephedra alkaloids, a dietary ingredient used for weight loss and bodybuilding, among other things, the ban became effective only after the FDA received thousands of reports of adverse events including a number of deaths and 10 years after the Agency issued its first advisory.” In the past, the FDA has cited insufficient data and underreporting of adverse events, however, under the new CGMP (current good manufacturing Rule, serious illness and deaths must be reported through MedWatch, however, as with everything, it is only as good as it the information received.
Some of the requirements for dietary supplement companies or manufactures are to report the identity of the company, types of products currently available in the marketplace and any adverse events reported associated with these products, however, the FDA has no way of determining as to whether or not these companies made any unsupported or incorrect determinations as to whether or not any new dietary ingredient has been added or whether or not it is generally recognized as safe (GRAS). These companies are not required to notify the FDA of their self-determinations. The majority of bans or recalls that are published are usually voluntary on the part of the manufacturer, however, it is questionable as to whether or not it is done to instill consumer confidence or that they are in fact investigating their own product to establish any adulteration, significant or any reasonable risk. FDA lacks the mandatory recall authority admittedly as understaffed and under budgeted when it comes to enforcing rules and regulations in a timely fashion as it relates to the dietary supplement industry. Usually when the consumer hears of a “banned” or “recalled” product, it is presumed that the products that are not banned or recalled are safe. This is a misnomer. Stages for FDA to enforce a real ban follows the following protocol: 1) hold regulatory meeting with the firm; 2) issue a firm warning; 3) issue consumer alerts; 4) issue advisory to industry; 5) work with company on voluntary product recall; 6) detain/refuse the product if imported; 7) pursue legal action against the firm; and, 8) ban the ingredient. Historically, the last real FDA ban was with Ephedra in 2004, almost 10 years after issuing its first advisory.