Recently two companies, Synticare Corp and Birkdale Medicinals, received warning letters that began, “This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website and has determined that (the following products are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.”
This boilerplate language appears on all such warning letters and forms part of a long-standing policy on the part of FDA’s Center for Food Safety and Applied Nutrition to comb through websites for possible claims violations. Warning letters, like those issued to Synticare and Birkdale, then follow, without an inspection as is the case with GMP enforcement. The program is a more efficient use of manhours than inspecting plants (though it is not a replacement for that activity) but even with that greater efficiency, it is still subject to time and money constraints.
Extension of the label
“Website material is often looked at by FDA as part of a product’s labeling. From FDA’s perspective it is promotional material and FDA will evaluate it as they would with any piece of promotional material, just as they would if they picked up a pamphlet they picked up on a trade show table,” Jason Sapsin, a Denver-based attorney with the Polsinelli law firm, told NutraIngredients-USA.
“By its nature (the program) can be a little hit or miss, because the web is a big place. From a manufacturer’s perspective, there can be an element of randomness to it.
“Because there is such an enormous amount of information on the web, they are pretty selective about what letters they send out,” Sapsin said.
“One of the big criteria is whether the website language refers to what I call a trigger condition or a trigger disease. A great example is during flu season you get from the agency what we call ‘flu letters,’ which refer to web materials on dietary supplements and their ability to prevent flu infection,” he said.
Macular degeneration and cancer
In the case of Synticare, the company was cited by FDA for claims that its products can treat macular degeneration.
“These macular degeneration formulas contain specific antioxidant vitamins for the treatment of macular degeneration,” is one of the statements cited by the agency in the letter.
In Birkdale’s case, the company mentioned in its website language mentioned the biggest trigger condition of all: cancer.
Among the language FDA cited in the letter was this: “Studies have shown that medicinal mushrooms [an ingredient in your product] contain … properties that … offer help … individuals with cancer, asthma, and other chronic illnesses."
In addition, FDA cited what it called noncompliant language on Birkdale’s website relating to cholesterol reduction, diabetes and liver ailments such as hepatitis and cirrhosis.
Lower warning letter bar
A key thing to remember about warning letters sent by the agency concerning website language is that they usually do not imply a prior back-and-forth process between the agency and the company. Warning letters that arise from GMP inspections are often issued months or even a year or more after the inspection in question, and imply a process in which a company has responded to 483 observations arising from the inspection and has failed to allay FDA’s concerns. In the case of website language, an inspector could see noncompliant language one day and send the warning letter the next. So these warning letters don’t fill quite the same enforcement niche as those that arise from facility inspections, nor do they address situations that are of as great a potential risk to consumers.
“The nature of the warning letter is supposed to be advisory; it doesn’t represent in and of itself formal enforcement action by the agency. It’s an advisory communication, a strong one,” Sapsin said. “Part of that has to do with the technology, because companies can change things on the web so fast. The idea is if you want to put a company on notice and really make it stick, go ahead and send the warning letter.
“It’s important to remember that just because FDA thinks you are in violation of the law, that doesn’t mean that you are in violation of the law,” Sapsin said.