New FDA Dietary Supplement Draft Guidance Seeks To Prevent Public Safety Problems

In response to mounting concerns about the safety of dietary supplements, which are not tightly regulated by the FDA, the regulatory agency has proposed new guidelines that call for the manufacturers to notify the agency when a product might include new ingredients that have not been thoroughly tested for safety. 

The FDA announced the revised draft guidance for dietary supplements on August 11. The guidance is an attempt to prevent public harm from the supplements, which the FDA cannot regulate unless they cause a public health problem.

While most dietary supplements are sold in the United States without FDA oversight, the Dietary Supplement Health and Education Act (DSHEA) requires a manufacturer or distributor to notify the agency at least 75 days before it puts a supplement on the market that contains a new dietary ingredient (NDI) not marketed in the U.S. before October 15, 1994. The only exception is if the NDI is already used in the food supply without chemical alteration.

This draft guidance instructs the companies how and when such notifications are necessary. It explains what qualifies as an NDI, when notification is required, how to submit an NDI notification, how to evaluate the safety of an NDI and what information the FDA needs to have.

“This revised draft guidance is an important step forward in the agency’s work to protect public health from potentially dangerous new dietary ingredients,” Steve Tave, acting director of the FDA’s Office of Dietary Supplement Programs, said in a press release. “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 The revised draft guidance is intended to improve the quality of industry’s new dietary ingredient reporting so the FDA can more effectively monitor the safety of dietary supplements.”

Critics say that the NDI rule is often too easily sidestepped. In a report in response to the guidance, Consumer Reports notes that chemicals already in the food supply are exempt even if manufacturers use them in a way that is potentially dangerous, citing pure powdered caffeine as one example.

In July 2014, the FDA issued a safety advisory about the potential health risks of powdered caffeine, warning consumers to avoid using the products after they were linked to reports of serious injury and death.

A recent investigation by the FDA has also shown an increase in hospitalizations from caffeine toxicity reported across the country in recent years, stemming from the use of energy drinks, shots and other products containing high amounts of caffeine and other stimulants.

With the popularity of pure powdered caffeine growing, the FDA has recorded an increased number of hospitalizations from toxic caffeine levels in younger generations across the country in recent years. Many of the cases are directly related to the use of energy drinks, energy shots, and other harmful caffeine stimulants labeled as “All Natural.”

However, because caffeine has been used in the food supply for centuries, the more dangerous powdered caffeine products are exempt from the NDI rule.

Consumer Reports claims manufacturers have scoffed at the NDI rule, noting that there are more than 90,000 dietary supplements on the market, with 5,560 new ones introduced annually. However, the FDA has received less than 1,000 NDI notifications over the past 20 years.

The new draft is a revision of one originally released in 2011, but the FDA indicates that there were several points that appear to have not been fully understood.