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A U.S. congressman has asked the FDA to respond to several warning letters issued by the agency in 2020 to dietary supplement companies that sell NAC (N-acetyl-L-cysteine) in their products. Sudden change" problem.

This is at least the second letter to the FDA from the US lawmakers regarding NAC this year. In its 2020 warning letter, the FDA stated that NAC cannot be sold in supplements because it was first approved as a drug in 1963, which aroused criticism from the dietary supplement industry.

Related: U.S. Senator, NPA presses FDA on NAC supplements

According to records submitted to the FDA by the American Herbal Products Association (AHPA), at least in the 1990s before the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994, the ingredient had been sold in supplements as part of its support. Two citizen petitions submitted by the Responsible Nutrition Council (CRN) and the Natural Products Association (NPA).

"Does the FDA believe that the purpose of DSHEA is to remove products that were safely marketed before 1994?" Representative Jeff Duncan (RS.C.) asked FDA Acting Commissioner Janet Woodcock in a letter on October 28.

Duncan represents a state with a number of well-known dietary supplement businesses, including international vitamin companies.

In this four-page letter, the congressman asked for several NAC-related answers, including:

-The number of NAC product structure/function declarations and new dietary ingredient (NDI) notifications submitted to the FDA;

-How the FDA coordinated the inconsistency in the classification of NAC when reviewing qualified health claim applications and the 2020 warning letter; and

-The FDA determines the specific date when NAC will be used as a drug and dietary supplement in the United States.

An FDA spokesperson stated that the agency has received the letter and will respond directly to members of Congress.

Duncan's letter is not limited to NAC. He also asked to answer questions about whether the FDA has effectively used its power to ensure that dietary supplement products entering the United States from China and other places are safe and comply with the law.

Although the FDA is seeking new authorization to require the listing of dietary supplement products in the agency, Duncan pointed out that "FDA has obtained basic information about the product," such as the dietary supplement label database maintained by the National Institutes of Health. According to several industry sources, Senator Dick Durbin (D-Ill.) is drafting a draft legislation requiring the mandatory listing of food supplement products to the FDA.

A spokesperson for Duncan's office stated in an email to Natural Products Insider that NAC "has been used as a dietary supplement ingredient for three years." "Unfortunately, this is another example of the FDA’s inconsistent interpretation of DSHEA. The industry plays an important role in the constituency of congressmen. He wanted to understand why the FDA targeted NAC and failed to resolve the entry from China to the United States. The crisis of adulterated products."

For example, Duncan mentioned Natural Alternatives International Inc. (NAI)'s request to the FDA to take enforcement action against adulterated forms of β-alanine. This topic is the subject of Natural Products Insider's four-part series of articles and a follow-up report on the FDA's rejection of NAI requests.

"How does the FDA determine that China's imported beta-alanine is not only safe but also does not violate US law?" Duncan asked Woodcock.

Dan Fabricant, NPA's president and chief executive officer, said that the FDA's alleged failure to effectively use its existing powers resonated with some lawmakers.

"You have an administrative branch, and it's actually saying,'Oh, no, I don't like the part of the law. I won't do anything here, but I really want to have some new authority. I I think this is what the members of Congress think," Fabricant said in an interview.

"There are so many loopholes now, instead of using the authority [FDA officials] do have to resolve these loopholes, they are going to talk about new authority?" Fabricant asked, who was previously responsible for overseeing the FDA's dietary supplement program department. "This is bad policy, and I think the legislators have seen it."

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