US FDA Announces New Pre Market Guidelines For Food Supplements

The revised draft replaces the FDA’s 2011 draft, and aims to help the agency identify safety concerns before products reach consumers.

 

Under the Dietary Supplement Health and Education Act (DSHEA), manufacturers or distributors must notify the FDA at least 75 days before beginning to market a dietary supplement that contains a new dietary ingredient, unless the NDI is used in the food supply without chemical alteration.

 

The FDA consider dietary supplements adulterated if they contain an NDI not used in the food supply and the required notification has not been submitted to the FDA 75 days before marketing.

 

A spokesperson from the FDA told NutritionInsight: “The FDA expects that this revised draft guidance, when finalized, will help strengthen its ability to identify safety concerns before consumers are exposed to potentially dangerous products.”

 

The refreshed draft comes after the FDA received feedback on the original 2011 draft, and aims to clarify several important points that were misunderstood or not fully explained.

 

It includes more detailed information on an authoritative list of “grandfathered” dietary ingredients, for example, dietary ingredients that are not NDIs, as well as better outlining the processes that result in chemical alteration. More information on synthetic substances and the dietary ingredient definition is also covered, as well as guidelines on manufacturing changes that create an NDI by changing the identity of an ingredient.

 

“This revised draft guidance is an important step forward in the agency’s work to protect public health from potentially dangerous new dietary ingredients,” said Steven Tave, acting director of the FDA’s Office of Dietary Supplement Programs. “Notification of new dietary ingredients is the only pre-market opportunity the agency has to identify unsafe supplements before they are available to consumers. The revised draft guidance is intended to improve the quality of industry’s new dietary ingredient reporting so the FDA can more effectively monitor the safety of dietary supplements.”

 

Estimations from the FDA suggest that there are more than 55,600 dietary supplements on the market, and that 5,560 new dietary supplement products come on the market each year. Despite this, the agency has received fewer than 1,000 NDI notifications since DSHEA was passed in 1994.

 

Over the past three years, the FDA has taken numerous actions on dietary supplements, including action on several products containing new dietary ingredients that pose safety concerns and should have been the subject of an NDI notification, but were not.

 

However, until the draft guidance becomes final, a manufacturer may choose whether or not to implement the recommendations. The FDA encourages public comments on the revised draft guidance during the 60-day comment period.