March 28, 2023
The head of FDA’s Office of Dietary Supplement Programs (ODSP) described a recently launched ingredient directory as a “neutral list.”
“The goal is not to be a list of ingredients to avoid,” ODSP Director Cara Welch told Natural Products Insider. “It is a neutral list of ingredients that we’ve acted on or communicated about.”
FDA in early March introduced for the public a new directory of ingredients used in products marketed as dietary supplements.
The Dietary Supplement Ingredient Directory includes links to FDA information on 27 ingredients: “5-Alpha-Hydroxy-Laxogenin; Acacia rigidula; Biotin; BMPEA; Cannabidiol; Cesium chloride; Comfrey; DMAA; DMBA; DMHA; Ephedrine alkaloids; Higenamine; Higenamine HCl; Hordenine; Hordenine HCl; Kava; Kratom; Methylsynephrine; N-acetyl-L-cysteine; Octopamine; Phenibut; Picamilon; Pure and Highly Concentrated Caffeine; Pyridoxamine; Red yeast rice; Tianeptine; and Vinpocetine.”
Many of the ingredients in the directory are substances marketed in supplements that FDA has raised safety concerns about, such as CBD, cesium chloride, DMAA, kratom and ephedra alkaloids, which FDA banned in supplements in 2004.
FDA also has determined many ingredients in the directory don’t meet the statutory definition of a dietary ingredient and are adulterated. Several ingredients also are, according to FDA, excluded from the definition of a supplement due to being either approved or authorized for investigation as a new drug before being marketed in a supplement.
However, Welch said FDA has not “communicated negatively about” all the ingredients on the list. For instance, she referenced red yeast rice. FDA has explained “red yeast rice is appropriate for use in dietary supplements, obviously avoiding issues with lovastatin,” she said.
To understand the nuances of red yeast rice, industry stakeholders unfamiliar with the issues must dig into the FDA materials.
On one hand, FDA’s ingredient directory states that “Red yeast rice is a source of lovastatin and monacolin K.” However, the directory also references an FDA press release from 2007 that warned consumers not to buy or eat three red yeast rice products marketed as supplements to treat high cholesterol due to the potential presence of an authorized drug, namely lovastatin.
The ingredient directory also highlighted two federal court cases involving Cholestin—a red yeast rice product that FDA argued was produced to contain lovastatin.
In 2001, in response to an order or so-called remand in 2000 from a U.S. appeals court, a federal district court judge in Utah upheld FDA’s determination that Pharmanex was manufacturing lovastatin and that lovastatin had not been marketed as a food or a dietary supplement before FDA approved lovastatin as a new drug in 1987.
Welch also mentioned biotin as an example of an ingredient in the new directory that is appropriate for use in supplements. The directory linked to a 2019 FDA update, which reminded people that biotin—an ingredient often present in supplements—can substantially interfere with certain lab tests and cause inaccurate results that may not be detected.
Welch acknowledged many of the ingredients in the directory are not proper for use in supplements, though she added, “by no means are they all intended to be that.”
“We hope that people actually click forward to whatever the communication would be about the ingredient,” she said in the interview. “It is important to get the context.”
The ingredient directory also represents an effort to consolidate information about certain ingredients.
“We get a lot of questions from various stakeholders, and at times we have to direct them to this webpage or a different webpage or explain the differences between the different webpages,” Welch explained. “The goal here is to avoid that, where we can have a single page of ingredients that we’ve communicated about or acted on, and they can find the information for themselves."
Retailers “can make an informed decision as to whether they want to sell that product … in their store, or if they’re a consumer, do they want to take that product?” Welch added. “If they’re a manufacturer, do they want to use that product in their formulation?”
In conjunction with launching the ingredient directory, FDA announced it has shuttered a former resource known as the “Dietary Supplement Ingredient Advisory List.” The advisory list was intended to alert the public when FDA spotted ingredients that did not appear to be lawfully marketed in dietary supplements.
But it “caused some confusion for our stakeholders, both industry and consumers,” Welch admitted. “And that was not the goal.”
FDA plans to update the ingredient directory, although Welch did not commit to a schedule for how often and when her agency would add ingredients and other information to the directory.
Finally, she said she expected that manufacturers and retailers are more likely than consumers of dietary supplement products to use the ingredient directory.
“We’re looking to get this information into the hands of our stakeholders,” Welch said. “This is pretty detailed information for consumers, I will admit. But there are consumers who are absolutely savvy enough to understand this list.”
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