FDA Overreaches in Liquid Product Draft Guidance – IASC, AHPA Joint Comments

February 4, 2010 – In joint comments filed Tuesday, the International Aloe Science Council (IASC) and the American Herbal Products Association (AHPA) assert the Food and Drug Administration (FDA) overreaches when it suggests that packaging or serving size may be factors – and potentially the only factor – that are indicative of whether a liquid supplement product is represented as a conventional food.

IASC and AHPA submitted comments in response to FDA’s draft guidance for industry, “Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and other Conventional Foods.” According to the draft guidance released Dec. 4, 2009, “Liquid products that suggest through their serving size, packaging, or recommended daily intake that they are intended to be consumed in amounts that provide all or a significant part of the entire daily drinking fluid intake of an average person are represented as beverages.”

However, IASC and AHPA point out that it is nowhere written in FDA’s food labeling regulations that serving sizes for conventional foods are reserved for conventional foods only. Likewise, there is no regulation that implies that any form of packaging is reserved to conventional foods and not available to dietary supplements.

“Simply stated, neither packaging nor serving size ‘represents’ the ‘form’ of a food,” said IASC Executive Director Devon Powell. “The first is required to carry and preserve the food for the consumer, and the second is required to be stated as part of the nutrition information for both dietary supplements and conventional foods.”

The trade associations also note the draft guidance fails to acknowledge and take into account prior statements by FDA regarding dietary supplements in conventional food form, and request that any final guidance be revised as needed to make all of the points previously communicated by the agency. For example, in the preamble to a final rule addressing nutrient content claims, health claims and statements of nutritional support for dietary supplements, FDA writes: “….a dietary supplement may be a product with physical attributes (e.g., product size, shape, taste, packaging) that are essentially the same as a conventional food, so long as it is not represented for use as a conventional food” (62 FR 49859, Sept. 23, 2997).

“The draft guidance represents new and original thinking by the agency that is in direct opposition to prior policy provided to industry in a rulemaking process,” said Powell. “If FDA does not accept the suggestions of IASC and AHPA, the issuance of an unamended guidance as final would constitute de facto rulemaking and be in opposition to the rulemaking requirements of the Administrative Procedure Act.”

The joint comments filed by IASC and AHPA are available here:
http://www.iasc.org/pdfs/10_0202_AHPA_IASC_Comments_FDALiquidProductsDraftGuidance.pdf

FDA’s draft guidance is on the agency’s Web site: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ucm192702.htm/