FDA Issues Guidance for Dietary Supplement Marketplace

The FDA announced guidance Thursday that allows manufacturers and distributors of dietary supplements to submit late new dietary ingredient (NDI) notifications if they have failed to do so. Directors from the administration will exercise “enforcement discretion” for a limited time, allowing marketplace groups to correct latent NDIs and inform the FDA of any ingredient changes that have been made to products.

“We remain committed to a flexible framework for dietary supplements that ensures the safety of these products for consumers,” stated Cara Welch, PhD, director of the Office of Dietary Supplement Programs.

The 1994 Dietary Supplement Health and Education Act granted the FDA authority to control dietary supplements. The act’s main requirements ensure that manufacturers and distributors notify the FDA before marketing any product with an NDI. The FDA also demands that products are not mislabeled or adulterated, and it can take action against companies that market products that are falsely advertised. This process is the leading power government authorities use to evaluate a dietary supplement before it reaches the consumer market. 

Director Welch also emphasized the benefit of restraining enforcement until NDIs are submitted: “The resulting notifications the agency receives through this period of enforcement discretion will help increase the amount of safety information we have about NDI-containing dietary supplements in the marketplace.”

Included in the FDA announcement were warnings to companies that remain non-compliant with FDA guidelines concerning dietary supplements. If the draft guidance goes through without change, the discretion enforcement discretion period would last 180 days and apply to products already on the market.

FDA officials are responsible for patient safety when companies attempt to market new medical products or supplements. Lately, the administration has sought to establish additional requirements for manufacturers seeking entry into the medical market. New legislation from the administration is now attempting to tackle the medical device security problems that have cropped up in recent years.

FDA approval of medical devices and drugs is an extensive and lengthy process designed to oversee an industry that would not otherwise regulate itself. The average approval for new products can take anywhere from 7 to 12 years and cost billions of dollars.

The administration also holds the power to ban substances, drugs, and devices it deems dangerous to the consumer. For example, the FDA has previously banned telemedicine devices and recently proposed a prohibition on flavored tobacco products that may take effect as soon as 2023.