Warning letter provides lesson in what not to do when citing science

By Hank Schultz contact

- Last updated on GMT

Related tags: Dietary supplement, Food and drug administration

Warning letter provides lesson in what not to do when citing science
A recent FDA warning letter to a company selling noni products provides a quick précis for what not to do when trying to support your product with science, said an attorney who reviewed the communication.

In its warning letter to Healing Noni Co​., a company based in Pahoa, HI, the Food and Drug Administration took the company to task for a variety of disease claims on its products.  Noni is the fruit of Morinda citrifolia​ tree. The fruit has a strong cheese-like odor as it ripens, and according to the company the juice starts to ferment while in the fruit. Noni juice is a whole spectrum product, and as such contains a wealth of chemicals, upon which FDA said the company was making a wealth of impermissible disease claims that included terms such as “antiseptic,” “anesthetic,” “fungicide,” “anticancer” ​and “anti tumor.”

“For one thing, I’d think FDA would have a problem with the company’s name. Dietary supplements aren’t supposed to heal diseases,”​ Marc Ullman, an attorney at counsel with the firm Rivkin Radler, told NutraIngredients-USA. 

For another thing, many of the disease claims that FDA cited were presented on the company’s website as a list of citations of studies found on the PubMed database. These included studies on noni’s effects on obesity, gout, arthritics and cancer.

“This doesn’t meet the standards of third party literature,”​ Ullman said. “You have to include the whole papers, not mere links to abstracts, and you have to include a full range, and not just cherry pick the positive studies. It has to be a balanced presentation. This looks like they just did a PubMed search on noni and included all of the positive studies.”  (​FDA noted 12 citations in all.)

Blurring the supplement/food line

In addition to the illegal disease claims, FDA also noted some GMP failures concerning the companies labeling and packaging processes.  In particular, though, the company failed in clearly delineating whether its product was meant to be seen as a food or a dietary supplement. The name says “juice,” but the company refers to it as a “liquid dietary supplement”. Not keeping those distinctions clear led the company into errors such as making nutrient content claims that didn’t meet the letter of the law in how those claims can be applied on packages. For example, the company said it’s product is a ““great source of Antioxidants, Vitamins, enriched Minerals.” This claim fails on several counts to match the regulation for the use of such claims, the agency said.

Experts have told NutraIngredients-USA on a number of occasions that if a company is marketing a liquid dietary supplement it is necessary to be thoroughly consistent about the messaging surrounding the product​. If the product is meant as a liquid dietary supplement, it should be referred to that way in every case, and food-like nutrient content claims should be avoided. Healing Noni appeared to have meandered back and forth between the food and supplement camps when talking about its product.

“Taken together, this is a classic example of what not to do,”​ Ullman said.

Healing Noni did not respond to a request for comment from NutraIngredients-USA.

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