Exploring NDIs, GRAS

LAS VEGAS When introducing a novel ingredient into the food or dietary supplement supply, consider two distinct standards that apply.

Federal law requires that manufacturers and distributors seeking to market dietary supplements that contain "new dietary ingredients" (NDIs) notify FDA about these ingredients and include in the notification a history of use or other evidence showing the new ingredient will be reasonably expected to be safe. The notice must be given at least 75 days before introducing the supplement into interstate commerce.

This obligation is a notification requirement, not a pre-approval requirement, noted seasoned lawyer Marc Ullman of the law firm of Ullman, Shapiro & Ullman, during the 2012 SupplySide West Global Expo and Conference in Las Vegas.

Richard Kraska, chief operating officer and co-founder of GRAS Associates, warns a notification does not preclude a finding that a product is "adulterated", though he says the burden of proof rests with the federal government. Products may be found to be adulterated under federal law if there is insufficient information to provide a reasonable assurance that the ingredient does not pose a significant or unreasonable risk of illness or injury.

A new dietary ingredient is one that was not marketed in the U.S. in a dietary supplement before Oct. 15, 1994, the date the Dietary Supplement Health and Education Act (DSHEA) was passed by Congress. Ingredients that were marketed prior to the law's passage are grandfathered in, says Ullman.

Now, consider a separate standard that applies to new uses of food additives. Substances included in food as a food additive generally are subject to premarket review and approval by FDA. One of the exceptions, however, includes substances that are "generally recognized as safe" or GRAS in FDA or lawyer lingo.

"For a substance to be GRAS, the scientific data and information about the use of a substance must be widely known and there must be a consensus among qualified experts that those data and information establish that the substance is safe under the conditions of its intended use," FDA has explained.

Kraska points out many GRAS determinations have relied on safety studies in literature without the need to conduct and publish additional studies. He further notes many GRAS determinations do not strictly follow FDA's Redbook guidance for food additives.

Determining which regulatory path to follow  NDI or GRAS is driven by a number of considerations, Ullman says, including the nature of the ingredients, the availability of safety data, marketing and the ability to comply with dietary supplement general manufacturing practices (GMPs).