FDA dings company on claims to prevent Lyme Disease
Unlike some other claims connected to ephemeral health crisis, such as the Ebola or SARs outbreaks of a few years ago, companies claiming to have products with benefits specific to Lyme’s Disease are a recurrent—albeit small—feature of the market.
Lyme’s Disease is an illness caused by the bacterium Borrelia burgdorferi. It is transmitted to humans via the bite of infected black legged ticks.
According to the Centers for Disease Control and Prevention, “Typical symptoms include fever, headache, fatigue, and a characteristic skin rash called erythema migrans. If left untreated, infection can spread to joints, the heart, and the nervous system.” The infection is typically treated with a course of antibiotics lasting several weeks, according to CDC.
Spring: Time for ticks, and Lyme claims
Like the ticks themselves, companies featuring these type of claims tend to crawl out of the woodwork in spring. In a warning letter, a company called Results RNA, LLC, FDA citied the Orem, UT-based firm for a variety of claims on a number of products grouped together as a kit marketed as ‘Ultimate Lyme Support Extra Strength.’
Among the impermissible claims the company was making was an ability of the company’s dietary supplements to selectively kill the infectious organism, and to reduce the neurological effects of the infection. Also, another product in the kit is aimed at detoxification, because in the company’s words “Pathogens such as Lyme associated Borrelia burgdorferi require a toxic host to survive. Boost your immune system and achieve long term health by cleansing your body of immunocompromizing toxic heavy metals and more . . .”
Criterion set in federal law
Attorney Justin Prochnow, a shareholder in the firm Greenberg Traurig, said there is not much wiggle room in federal law when it comes to claims associated with disease vectors.
“It’s pretty much fundamental that any sort of claim associated with a parasite is going to be a disease claim,” Prochnow told NutraIngredients-USA.
According to Criterion 8 of the Structure/Function rule of 2002:
“A claim that a dietary supplement fights disease or enhances disease-fighting functions of the body is a disease claim. Under this criterion, context and specificity are important. Claims such as ‘supports the body's ability to resist infection’ and ‘supports the body's antiviral capabilities’ are disease claims because the context of the claim is limited to the disease prevention and treatment capabilities. However, a claim that a product ‘supports the immune system’ is not specific enough to imply prevention of disease because the immune system has both structure/function and disease fighting roles. A general claim of this type doesn't specifically focus the intended use of the product on the disease aspect of the system's function.”
“When ‘disease’ is in the name of a thing you are trying to treat, it’s hard to get around this regulation with a claim,” Prochnow said.
