Modifications Advised For Dietary Supplement Notification System

Apr 16, 2020

DSHEA is an acronym that stands for the Dietary Supplement Health and Education Act of 1994. This law grants the FDA adequate legal authority and enforcement capabilities to safeguard consumers, yet allowing them the freedom to access a wide range of inexpensive, high quality, and secure dietary supplement products.

Under this legislation, the DSHEA categorized dietary supplements as food. It also ordered that ingredients in dietary supplements could not be “regulated” as food additives. Furthermore, before companies market “a new dietary ingredient”, manufacturers are required to submit a “New Dietary Ingredient Notification” (NDI) to the FDA in order to judge that the ingredient to be used “is reasonably expected to be safe.”

The DSHEA also gave the FDA enforcement authority to remove products from the market if they are deemed unsafe with the potential risk of illness or injury.

Scott Bass, an attorney who leads Sidley Austen’s LLP’s Global Life Sciences team, was a key player in the development of the DSHEA. Bass, along with Pieter Cohen, an internist at Cambridge Health Alliance and associate professor of medicine at Harvard Medical School, co-authored a paper in the New England Journal of Medicine. This paper proposed a requirement that all manufacturers submit all new dietary ingredients or NDI’s to the FDA for review.

DSHEA No Longer Adequate

Cohen has been a staunch critic of the DSHEA, as he questions its competency to protect consumers. Through his extensive scientific research, he has detected “safety-related concerns” over many products sold as supplements.

The supplement industry’s origins were a small and unassuming market that has exploded into a more complex industry.

Bass and Cohen stated in the article:

“Today, this law does not adequately protect the public. Since it was written, the supplement industry has been reshaped by Internet sales and an increasingly complex global supply of new substances. What was a $[US]4 billion market in 1994 with a few thousand products has grown into a more than $40 billion market with tens of thousands of dietary supplements.”

According to the authors, the FDA does not review the majority of these ingredients, despite the clear mandates given in the new dietary ingredients requirement of the DSHEA. 

Eliminating The Loophole

The paper also seeks to eliminate an exception within the DSHEA to the NDI notification or (NDIN) mandate. This loophole has essentially taken over, if not overridden the law. The DSHEA set out to allow this exception be used “infrequently”, but apparently, the verbiage within the law is not clear. It was not meant to be used for new chemicals, synthetic compounds, or combinations. However, the FDA seems to have approved this loophole to allow numerous substances to be released without submitting safety data.

Industry experts agree that more dietary ingredient notifications should have been filed with the FDA in the last 25 years. However, the FDA defends its position that it is oblivious to the number of dietary supplements on the market since there is no requirement to be listed with the government.

Looking Ahead

It is difficult to pinpoint where the weak link lies within the supplements industry. Is it the effectiveness of the NDI process? Does it originate from weakness within the law itself? Or does it center around the fact that the FDA has failed to enforce its requirements? For now, it is without question that the industry should act responsibly and protect its consumers.

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