Prochnow, who is based in the Denver, CO office of the law firm Greenberg Traurig, said the letter is one of only a few FDA has sent that bears on the subject and the first since the middle of last year.
In the letter to a company called Nature’s Health Options, the company was cited for a number of deficiencies, including violations of GMP requirements. Natures Health manufactures its products via a contract manufacturer, but failed to have adequate records of that was done, and did not have adequate written procedures relating to recall and holding procedures and the collection of adverse event reports.
“Your firm has an obligation to know what and how manufacturing activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications,” the letter states.
Blurring the line
In addition, though, FDA included mentions of how the company markets its Charantea Ampalaya tea that carries a dietary supplement facts panel on the label. A product marketed as a supplement cannot be also represented as a conventional food, FDA said. Among the noncompliant marketing statements that FDA cited were:
“Taken as tea, Charantea is a great alternative to coffee or traditional teas . . ..” and “Instead of coffee or sugary drinks to cap your meals, make Charantea your healthy after-meal beverage.”
The letter offers a clear view of what FDA is looking for when deciding if a liquid product is blurring the line between supplement and beverage, Prochnow said.
“You have to be very careful about what you say about the product. If you start calling it a tea, or an alternative beverage, you could have problems,” Prochnow said.
FDA has a guidance on the subject of liquid dietary supplements that has lingered in draft form for a number of years, Prochnow said. Although the agency has said on several recent occasions that it intends to finalize the guidance (and has been urged by some prominent members of Congress to do so) there is no time frame to that, and such guidances are sometimes never finalized, Prochnow said. Nevertheless, it gives a look at the decision tree FDA uses to make such determinations, he said.
Start with serving size
First is serving size. A liquid supplement dosed via dropper or a shot-type product is unlikely to be viewed by the agency as a potential beverage. As the serving size approaches what consumers equate with drinks, somewhere in the 8 oz range, the issue becomes cloudier.
“No one is saying 5 hour Energy in the two ounce shot is a beverage. But if the serving size and the packaging looks like a beverage, FDA will consider a series of factors,” Prochnow said.
“If you are already getting behind, as when the packing or serving size looks like a beverage, then you have to be doubly careful. You should avoid using the terms ‘beverage’ or ‘drink’ on your package or on your web site.”
Consistency is key
A company needs to be crystal clear in its own mind of how it views its product, Prochnow said. The bottom line: “You have to go all in one way or the other. If you are inconsistent in your messaging, you are allowing FDA to decide whether your product is a supplement or a beverage,” he said.
Another issue raised by Sens. Dick Durbin, D-IL and Richard Blumenthal, D-CN, is that in their view companies switch back and forth from beverage to supplement to get the best regulatory deal. The lawmakers seem to believe that companies are ‘hiding’ under supplement regulations.
Question of ingredients
“I think the reason companies do that (choose to market as a supplement as opposed to a beverage) are different than what Congress thinks they are. It has almost always come down to an issue of ingredients and whether your ingredients have GRAS status (for use in foods),” Prochnow said. If a liquid supplement has non GRAS ingredients (allowable under the regulations), it calls for a company be doubly careful about how it positions the product. If FDA decides after all the product is a beverage, having non GRAS ingredients will automatically cause it to be adulterated. And supplement regulations are more stringent than food regs in some ways, despite what the lawmakers seem to have assumed, Prochnow said.
“With the huge crackdown on supplement GMPs there are a lot of companies that have sold their products as supplements that are switching to selling as beverages because they don’t want to incur the cost of meeting those regulations,” Prochnow said.