AHPA Tells FDA: No Need for Separate "Functional Foods" Rules

(December 5, 2006, Silver Spring, MD) — Noting that the Food and Drug Administration (FDA) already has full authority to ensure that foods and food ingredients are safe, the American Herbal Products Association (AHPA) today stated that additional regulations for so-called "functional foods" are not needed. AHPA presented its position and recommendations at an FDA hearing that was called to consider whether new federal regulations for functional foods should be established.

Anthony Young, Esq., AHPA’s general counsel, spoke for AHPA at the public hearing. Mr. Young noted that such functional foods as Total® cereal, launched in 1961, and Gatorade®, introduced in 1965, have been safely consumed for several decades. The requirements for all ingredients added to foods to be generally recognized as safe (GRAS) include a notification process for novel ingredients, and provides an established framework that applies to functional foods.

"The GRAS notification system works, and it works well," Mr. Young said. "AHPA recommends FDA use current law to address the use of novel ingredients in functional food. No new system is required."

Mr. Young suggested that FDA could establish a voluntary food claims notification process that parallels the GRAS ingredient notification process for those who want added assurance of FDA review. He also noted that the current food law is already relevant to functional foods, and includes provisions for claims to be truthful and not misleading and for labels to disclose any material safety information.

Much of the concern about functional foods seems to focus on beverages, Mr. Young noted, particularly those that contain caffeine. In March 2005, AHPA adopted labeling guidelines to require dietary supplement products that contain 25 mg or more of caffeine to disclose both the presence and the amount of caffeine. In his presentation at today's public hearing, Mr. Young said that AHPA recommends that FDA use its authority to initiate a new rule that would require the amount of caffeine added to food be stated on the product label.

When FDA announced this meeting, it also opened a public comment period. Written or electronic comments may be submitted until January 5, 2007. For background information and instructions on submitting comments, the Federal Register notice is online at http://www.fda.gov/OHRMS/DOCKETS/98fr/06-8895.pdf.


The American Herbal Products Association (AHPA) is a trade association representing the core of the botanical trade -- comprised of the finest growers, processors, manufacturers and marketers of herbal products. AHPA’s mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of quality with respect to the way herbs are manufactured, labeled, and sold. Website: www.ahpa.org.

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