Part 2

FDA’s Welch on enforcement: ‘Sometimes you need a hammer but, at times, the hammer is not the best option’

By Stephen Daniells

- Last updated on GMT

© bankrx / Getty Images
© bankrx / Getty Images

Related tags Cara Welch Fda Dietary supplements enforcement Dmaa phenibut Kratom warning letters

Ingredient-specific actions, as evidenced recently by warning letters to 10 firms in the sports nutrition space, are important to FDA’s regulation of dietary supplements but additional actions are hampered by having to deal with problematic ingredients still on the markets, said Dr Cara Welch.

Referencing recent warning letters from FDA to 10 firms​ regarding the use of 5-alpha-hydroxy-laxogenin, higenamine, higenamine HCl, hordenine, hordenine HCl, and octopamine, Dr Welch, Director of FDA’s Office of Dietary Supplement Programs, noted that, in some cases, the ingredients are new dietary ingredients for which FDA has not received a notification. In other cases, the ingredients are unsafe food additives.

“The definition of dietary supplement is very ingredient specific,” ​said Dr Welch at last week’s GRMA Summit in Chicago​, “and the products we identified with these violative ingredients are a product integrity problem, if not also a consumer safety problem.”

Industry can often voice frustrations that warning letters cite ingredients that have been the subject of previous warning letters, suggesting to some stakeholders that FDA’s actions are not as effective as desired.

“That frustration – the idea that FDA is sending yet another warning [about the same ingredient] – is warranted,” ​said Dr Welch. “It’s something we in the Agency struggle with as well.

“Looking back over the past seven or eight years, we’ve spent time and resources evaluating various ingredients and describing how they’re not appropriate for use in dietary supplements. Usually, we communicate this through warning letters. But we have to come back to the same ingredient time and again because we keep finding more products containing these ingredients."


Dr Welch highlighted the case of DMAA, which was the subject of numerous warning letters as early as 2012​. Products containing the ingredient have been the subject of seizures over the years.

And yet FDA continues to find products on the market formulated with DMAA. And the same can be said of other ingredients that the Agency has identified as inappropriate for dietary supplements, such as phenibut​ or kratom​.

Seizures, injunctions, and import actions are all part of the FDA’s toolbox, she said. “Sometimes you need a hammer – and we are not afraid of aggressive action to remove products from the market – but at times, the hammer is not an option or is not the best option.

“We’re looking to take a multi-faceted approach. Looking to differentiate the legitimate marketplace from these other products that are looking to profit off the compliance efforts of responsible industry.”

Dr Welch said that ODSP is looking to communicate and be more transparent about which ingredients it has reviewed and what the Agency’s thinking is. While there is no definite list of legal dietary ingredients, FDA does have the dietary supplement advisory list, as well as ingredient specific pages.

This information is shared in an attempt to be transparent with stakeholders, she said.

“We all benefit from a well-regulated marketplace, and thus we all have a responsibility to improve the marketplace,” ​said Dr Welch. “The support of industry in not using these ingredients, or retailers in not selling these products, can further serve to differentiate the legitimate marketplace from these violative products.”

Changing the conversation around dietary supplements

“But communicating needs to be beyond communicating with manufacturers and retailers,” ​said Dr Welch. “From FDA’s perspective, it’s so important that consumers are also educated about dietary supplements.

“We also benefit from an informed consumer. This is a $50 billion industry. Four out of five Americans take supplements, so it’s important that consumers have the ability to make informed decisions about the products that they are taking.”

The Agency recently launch the “Supplement your Knowledge”​ initiative aimed at broadening the collective knowledge about dietary supplements.

Part of the initiative is a high-school curriculum, with the idea being to cultivate an educated consumer base, starting with high-schoolers (if they’ll listen), said Dr Welch.

“We’re excited to see how this changes the conversation around dietary supplements,” ​she said.

Click HERE​ to read part 1 of this report.


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