Online supplements retailer heeds FDA warning letter advice, but fears business impact

By Shane Starling

- Last updated on GMT

Related tags Fda warning letter Fatty acid Omega-3 fatty acid Dietary supplement

NutriHerb has complied with the FDA's demand it change its claims but will the action kill its business?
NutriHerb has complied with the FDA's demand it change its claims but will the action kill its business?
“You gotta do what you gotta do,” an exhausted Cathy Keys told NutraIngredients-USA today after spending the best part of two months completely renovating her family-run online supplements business,, after receiving an FDA warning letter in December last year.

Keys, the firm’s owner and managing director, said all therapeutic claims that the company had happily been making since building the website in 2001 – and for seven years before that via labelling and print – had been removed, an action she feared could put a severe dent in its profitability.

“Not being able to make claims could well run us out of business,” ​she said. "We were surprised to receive this letter as we did not know the claims were illegal but took steps immediately to comply.​"

The FDA warning letter, sent December 2 and which can be found here​, highlighted unauthorized drug claims for three products – Custom Advantage Chamomile; Custom Advantage CoQ10 and Custom Advantage Omega-3 Fatty Acids – and gave NutriHerb 15 days to take corrective action.

“We rang them and after discussing it decided to remove all therapeutic claims from our site,” ​Keys said. “Because there was so much to do they gave us a 60-day extension and we have just written to them to notify them that the work has been completed.”

Keys said she had scanned the FDA-approved list of qualified and unqualified health claims, but said the process was so elongated and expensive that NutriHerb would not be pursuing it.

The firm does also have the option to make structure/function claims provided they can substantiate them.

“Being a small family business, we have a small marketing budget, so I have no idea how we are going to market our products now,” ​she said.

Another warning letter dated December 21 sent to another Florida-based company regarding unauthorized drug claims for a range of sea algae derived calcium-osteoarthritis supplement products had not as yet been heeded.

Natural Option USA Corporation continues to market OsteOrganiCAL with testimonials and references to studies the FDA has deemed amount to drug claims on its website.

However the company said it was, "in the process of removing the claims".

That letter can be found here.

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GMP Compliant?

Posted by Bert,

Bill I agree with you, these guys are sloppy, perhaps lazy, and clearly don't understand the law. They haven't even bothered to read the structure/function rules. What do think the chances are that they have read the GMPs? Looks to me that they have an encapsulating machine in the garage or basement and a shelf full of stale raw materials. I'd love to see the FDA inspection report on this one! Unreal.

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The Price to Pay

Posted by brian,

Requirements on health claims is nothing new and has been around back in 2001. Many companies simply don't look into regulatory requirement and just market however they please - as their priority is to sell the product right away. If they did this research up front, it would have helped them avoid it. I urge all companies to hire good regulatory consultant to help them through at product development/business development. "not knowing" is not an excuse for not complying with the regs. And yes, i can see the differentiation between health claim and testimonials but the average consumer may confuse the two and that's where FDA is concerned. IF a page is loaded with "cancer curing" testimonials, then the average consumer may believe that this is what the product is supposed to do... no one's fault - but FDA has to keep this in mind when drawing up their requirements.

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Can testimonials be considered a claim?

Posted by ml,

It is a little disconcerting that in the case of OsteOrganiCAL that testimonials were considered a medical claim. Seems a little contradictory to protections afforded by the First Amendment of the US Constitution. As far as claims made by the companies cited in this article, I agree that the FDA was correct. But claims by a company and personal testimonials are very different.

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