Lack of adequate counsel when setting up operations can lead to big regulatory headache later

By Hank Schultz

- Last updated on GMT

Lack of adequate counsel when setting up operations can lead to big regulatory headache later

Related tags Warning letter Company Gmp violations Food and drug administration

A recent warning letter to a Colorado dietary supplement company illustrates the hot water companies can get themselves into when starting business operations without adequate counsel.

In a warning letter to a company called MusslMaster, located in Wheat Ridge, CO, the Food and Drug Administration (FDA) cited the company for a lengthy laundry list of violations, including impermissible drug claims, labeling inconsistencies, and GMP violations. The company sells its products on its website,​, and through a free-standing facility in Wheat Ridge called Green Herb whose sign bills it as offering “herbal counselling, chiropractic and acupuncture.”

On the company’s website, the warning letter alleges the company has been making claims for its products to treat cancer, to help slow the progression of Alzheimer’s disease, to free users from the need to take medication for acid reflux disease as well as a host of others. As it does with all such cases, FDA said such clams push the company’s products over into the category of unapproved drugs. As of this morning, the acid reflux testimonial claim, specifically cited in the warning letter, is still front and center on the company’s website. The company did not respond before publication time to a request for comment.

In addition to the drug claims, the agency cited numerous deficiencies with the company’s labels. These included not using the accepted names for constituents and such basic issues as failure to clearly identify the products as dietary supplements.

In the GMP realm, the company’s failures were manifold. The company failed to establish standard operating procedures, had gaps in its batch production records and a lack of specifications. In addition, the company had no records of personnel training, nor had any procedures around the retention of samples or the collection of consumer complaints.

Mournful trifecta

Justin Prochnow, a shareholder in the firm Greenberg Traurig, told NutraIngredients-USA that in such cases he looks at whether a mournful trifecta has been hit.

“There’s the triple threat of warning letters. Disease claims, labelling violations and GMP violations,”​ he said. When clients in similar situations consult with him he has a triage procedure he goes through to help clean up the mess.  He starts with the easiest things to fix, which are usually the disease claims that might appear on the company’s website. (Note, MusslMasster is not Prochnow’s client.)

“I have certainly worked with companies that are in this position. You’d break down the warning letter into sections, while keeping in mind that the warning letter may not list all the things that could be wrong,”​ he said.

“The disease claims here are pretty explicit. Cancer, depression, all sorts of things. The easiest thing would be to first take those off of the website,”​ he said. “Then I might enlist the services of a good GMP consultant who could make sure they get their GMPs in line. It’s the GMP failures that are going to be the biggest issue and the area where FDA is going to be most interested in seeing compliance.”

The process from 483 to warning letter can sometimes be a protracted one, but Prochnow said that companies shouldn’t assume they can keep the agency at arm’s length forever.

“You get the 483, they don’t like the response to that so then you get the warning letter. If they don’t like the response to that, that’s when they start talking about a consent decree to shut down your business until you can demonstrate compliance,”​ he said.

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