Tuesday, February 16, 2010

The How and Why of the Dietary Supplement Safety Act of 2010 Proposed by Senator McCain

BY Dr. Arianna Staruch, ACHS Academic Dean

In Jan 2009, the Government Accountability Office (GAO) released a report suggesting that the FDA should take further actions to improve oversight and consumer understanding of dietary supplements. This report was triggered by the three-fold increase in adverse event reports received by the FDA since mandatory reporting went into effect on December 22, 2007.

The GAO wanted to know if the FDA was able to “identify and act on concerns about the safety of dietary supplements, and foods with added dietary ingredients, and to ensure that consumers have useful information about the safety and efficacy of supplements.”[1] What it found was that the FDA “has limited information on the number and location of dietary supplement firms, the types of products currently available in the marketplace, and information about moderate and mild adverse events reported to industry.” In addition the FDA “is hindered by a lack of mandatory recall authority and the difficult process of demonstrating significant or unreasonable risk for specific ingredients.”[2]

There is also concern that some food products could be marketed as dietary supplements to circumvent the safety standard required for food additives.

In response to this GAO report, Senator McCain proposed the Dietary Supplement Safety Act of 2010.[3]

To address the lack of information about dietary supplement firms, the bill proposes the registration of “dietary supplement facilities” which would be required to file annually a list of all dietary supplements “manufactured, packaged, held, distributed, labeled, or licensed by the facility,” including the names and address of each facility and all trade names. This will most likely create record maintenance obligations for downstream manufactures and retailers, who will be obliged to obtain written confirmation, from ingredient suppliers or from supplement brand marketers. According to Michael McGuffin, president of the American Herbal Products Association (AHPA), this “places new burdens on dietary supplements that are not required for any other class of food.”

In addition, the Dietary Supplement Safety Act of 2010 bill would change the “grandfather” status of dietary supplement products marketed in the U.S. prior to the Dietary Supplement Health and Education Act (DSHEA), before October 15, 1994. It instead establishes a list of “‘Accepted Dietary Ingredients’, to be prepared, published, and maintained by the Secretary,” and defines a new dietary ingredient as any ingredient not included on such list. Any substance not on the list would have to be submitted to the FDA 75 days before being used in a supplement with data supporting its history of use and safety.

The Government Accountability Office wants to extend the mandatory reporting of adverse event from the current serious adverse events to mild and moderate adverse events, with the manufacturer keeping records on all of them for a minimum of three years. The AHPA notes, “Marketers of conventional foods have no adverse event reporting requirements, even for serious adverse events.”

In addition, the GAO wants the FDA to have recall authority over supplement products, to order the cessation of distribution, notification of distributers, importers, retailers and consumers, of any product that is determined to cause serious, adverse health consequences or death, or is adulterated or misbranded. The problem here is that products could be considered adulterated if it has an ingredient not on the established list, or if the formula was changed or reformulated and the change was not registered or updated, even if this change does not present any hazard to the public. Herbs can vary in availability and quality and sometimes formulas are changed to maintain the overall effectiveness of the product. McCain’s bill includes monetary penalties for non-compliance with these regulations

What is of particular interest is the loss of supporters reported by Senator McCain’s office: Major League Baseball, the National Basketball Association, the National Football League, the National Hockey League, the United States Olympic Committee, the American College of Sports Medicine, National College Athletic Association, and the PGA Tour.

This gives the impression that what McCain is really trying to do is to curb the use of herbs and supplements that might have anabolic or performance enhancing effects and are currently “getting around” regulations.


[1] GAO-09-250 January 29, 2009

[1] GAO-09-250 January 29, 2009

[1] http://ahpa.org/Portals/0/pdfs/10_0202_Dietary_Supplement_Safety_Bill.pdf

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