New Dietary Ingredient Safety Review Examined in Journal: FDA Shown to be a Strict Gatekeeper

New Dietary Ingredient Safety Review Examined in Journal: FDA Shown to be a Strict Gatekeeper

Silver Spring, MD (July 23, 2004) — An article published in the current issue of Food and Drug Law Journal (FDLJ) shows the Food and Drug Administration (FDA) is fulfilling its role as gatekeeper, ensuring that new dietary ingredients (NDIs) are safe prior to coming to market.

Dietary supplements — such as vitamins, minerals and herbs — are regulated by the Dietary Supplement Health and Education Act. That law “grandfathered” ingredients already on the market, and instructed FDA to establish regulations to receive notifications about the safety of ingredients introduced after the law went into effect in 1994. In the first nine and a half years since the law was passed, FDA received 145 unique notices of proposed new ingredients. FDA has objected to 68 — or 47% — of these notifications, either because the submissions were incomplete or provided inadequate data to support safe use of the ingredient, or because the ingredient itself or the product that would contain it did not fall within strict legal definitions. The FDLJ article offers practical suggestions as to how companies can file a notification that is acceptable to FDA.

“FDA has developed some consistency in implementing the regulations for new dietary ingredients,” said lead author Michael McGuffin, president of the American Herbal Products Association. “At the same time, the agency needs to make information available more promptly, and marketers of new dietary ingredients need to better understand the detailed application of these regulations.”

Marketers of any dietary supplement that contains a new dietary ingredient are required by law to provide information to FDA that is the basis for a conclusion that the product is reasonably expected to be safe. FDA is authorized as the sole arbiter in evaluating whether the information provided is sufficient to meet this legal standard.

“Every industry relies upon the development of new products,” added McGuffin. “Companies that learn to navigate the FDA review process for new dietary ingredients will have a real market advantage in an industry that demands innovation.”

The article is titled “Premarket Notifications of New Dietary Ingredients – a 10 Year Review” and was written by McGuffin and Anthony L. Young, Esq., Kleinfeld, Kaplan & Becker.


The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal supplement industry. Founded in 1983, AHPA is the recognized leader in representing the responsible core of the botanical products industry, and is comprised of the finest growers, processors, manufacturers, and marketers of herbal products. Website:

The Food and Drug Law Journal is published four times per year by the Food Drug Law Institute. For over 50 years, this award-winning peer-reviewed journal has offered readers scholarly, in-depth, analytical articles, providing insight into the actions of FDA, FTC, and USDA, how the courts interpret these actions, and the reaction of industry. Website:

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