Literature from trade show booth puts company in hot water with FDA

In a warning letter sent to Viva Nutraceuticals​, based in Ferndale, WA, FDA took the company to task over claims it was making on a number of dietary supplements it markets. The letter cited claims made on eye health products, products containing ginkgo biloba, omega-3s and others. Among the non compliant claims cited in the letter that the company had posted on its website were the following, which included a cancer treatment claim, something that observers have said is a sure-fire way to get regulators’ attention:

• “Used in herbal medicine to help slow the progression of disorders of the eye . . . “​
• “Lowers blood pressure in hypertensive individuals”​
•  “Lower cholesterol levels”​
•  “Protects against cardiovascular diseases.”​
• “[P]rotect against development of cancerous prostate cell lines.”​

In the letter FDA said it found many more non compliant disease claims in promotional literature that was distributed by the company at the Natural Products Expo West trade show in March of this year. The warning letter did not specify if FDA collected this literature itself or if it had been forwarded by a third party. These claims were even more explicit about the company’s belief in the disease-fighting potential of its products. Among those claims were:

• “The ingredients . . . slow the progression of diabetic and hypertensive retinopathy.”​
• “Clinically effective in treatment of alcoholic cirrhosis.”​
• “Clinically improves cognitive function (Alzheimer’s disease, vascular or mixed dementia).”​

FDA can and will make up its own mind​

It’s unusual, but not unheard of for FDA to mention the content of promotional literature in a warning letter. In any case, the key point to remember is whatever a company puts out about its product in any venue can be used by the agency to form an opinion about the company’s intent when it brings a product to market, said attorney Jason Sapsin with the firm Faegre Baker Daniels.

“Consistency for consistency’s sake isn’t important,” ​Sapsin told NutraIngredients-USA. “What’s important is that the company evince a genuine intent to offer a dietary supplement product as opposed to a drug.​

“It doesn’t matter if the material is seen by a competitor, a customer, a consumer or a regulator. Everything a company puts out should clearly show it intends to offer a dietary supplement. If that intent isn’t firmly held, or isn’t a sophisticated intent in terms of understanding the law, the FDA can come to a different conclusion,” ​he said.

Some observers seek to cut dietary supplement promoters some slack, saying that zeal gets in the way of good judgement, and that these entrepreneurs’ passion to help people is what can underlie messages like these, not a desire to deceive. Sapsin said in a regulator’s eyes, that kind of consideration is irrelevant, and that in this day and age it’s hard to claim ignorance of the regulations.

“Even just as a factual matter with the wealth of information that’s out there in the form of programs, seminars and web-based resources, it really makes it hard to gain the sympathy of a regulator on the simple point that a company didn’t understand the rules. I think what’s happening is that we need to come to a place where it is not just a legal but an ethical responsibility to understand the rules of the road,”​ Sapsin said.