CSPI Petition Sparks Industry Controversy

CSPI Petition Sparks Industry Controversy

WASHINGTON--The industry has been abuzz the past month as regulation issues have come to the forefront. The media found a new word to describe herbal products: "unregulated," and the controversy it sparked all began with a report from the Center for Science in the Public Interest(CSPI). The CSPI along with an herbalist and Connecticut's attorney general, filed a petition on July 19 with the Food and Drug Administration (FDA) to stop the sales of 75 products sold as "functional foods." Among the products named in the petition as "modern-day snake oils" were Snapple's Moon Tea, Robert's American Gourmet Echinacea Shells and Arizona Iced Tea's Rx Memory Elixir, which contain kava kava, echinacea and Ginkgobiloba, respectively.

CSPI's petition made news across the country, appearing in news outlets from the Associated Press and Reuters to CNN, ABC, the Philadelphia Inquirer and Howard Stern's radio show. The petition called on the FDA to pull products from the market that are labeled as "functional foods." It said they pose a health threat to consumers.

"Herbs are drugs," said Varro Tyler, the herbalist involved in the petition. "We do not add Viagra to soup. We do not spray Prozac on corn chips." According to Tyler, this new trend is "a disaster waiting to happen" since uninformed consumers could potentially ingest strong doses of herbs that may cause unwanted reactions. If the doses are not as strong as inferred on the labels, then consumers are the victims of mass deception, he said.

The Grocery Manufacturers of America (GMA) defended the functional food industry. It said CSPI was guilty of "frenzied overreaction" to the report released on July 11 by the U.S. General Accounting Office (GAO) titled "Improvements Needed in Overseeing the Safety of Dietary Supplements and Functional Foods." In that report, the GAO called on Congress and the FDA to enact more regulations for the oversight of functional foods and dietary supplements. It recommended that the Federal Food, Drug and Cosmetic (FDCA) act be amended to "require makers of functional foods to meet the same requirements that currently apply to dietary supplements" in terms of the safety and accuracy of health claims and structure-function claims on labels.

Within 24 hours of that report's release, the National Food Processors Association (NFPA) and Grocery Manufacturers of America (GMA) found fault in it and issued responses. "The safety of both dietary supplements and functional foods is of paramount importance to the food industry," said NFPA executive vice president, Dr. Rhona Applebaum. "FDA already has full enforcement authority to ensure that such claims [health and structure-function] for foods are scientifically supported and do not mislead consumers."

According to Dr. Stacey Zawel, GMA vice president, scientific and regulatory policy, "GMA believes the recommendations would unnecessarily re-regulate foods that already meet stringent federal food laws. The GAO apparently doesn't understand that 'functional foods' is a marketing term, not a regulatory term."

According to the Council for Responsible Nutrition (CRN), no safety problems have been reported with functional foods. However, if they did exist, FDA would have full authority to take actions, as provisioned by the FDCA.

"GAO misses the point," opined Anthony Young, partner with Washington, D.C.-based Piper & Marbury. "FDA has authority under the Food Additive Amendments and under DSHEA [Dietary Supplement Health and Education Act] to address the issue of dietary supplements in conventional food form or ingredients [that aren't GRAS] in foods. FDA has already made this a priority."

Others within the industry echoed Young's comments. "Those who sell [products such as these] must understand the regulatory requirements and restrictions for selling supplement ingredients in consumer goods," said Michael McGuffin, president of the American Herbal Products Association (AHPA). "An herbal ingredient may meet the GRAS requirements and can be sold as a dietary supplement, but if it's sold as food it must either be represented as a food or as a dietary supplement [i.e. the manufacturer must disclose amounts of the herb on the ingredient list.]" According to McGuffin, the gray area is the specific amount of an herb that is known to be an effective dosage amount. For example, if a drink lists 2.5 mg of Ginkgo biloba on the label and touts itself as a "memory-enhancing" beverage, how does that jibe if the known effective dosage amount is 1 gram?

"Companies need to address these issues," said Young. "At lesser levels, the question is whether the claims they make are substantiated. Each product identified by CSPI has to stand or fall on its own merit. The industry needs to address legitimate criticism," he added. "Dietary supplements in conventional food form are permitted underDSHEA. Those products need to be responsibly marketed in terms of relevant and material information on the labels and relevant amounts withinthe products."

For more information, visit these websites: www.gmabrands.com,www.cspinet.org, www.nnfa.org,www.ahpa.org, www.gao.gov.