Brooklyn-based cold pressed juice company JÙS By Julie, which markets a variety of blended ready-to-drink blended smoothies and shots as well as soups and salads, is revising multiple health claims featured on its website after receiving a warning letter from the U.S. Food & Drug Administration (FDA) last month.
In an April 5 letter addressed to Jus Bar President Sesar Melah, Ronald M. Pace, New York district director for the FDA, stated that claims made on the company’s website establish that the products are drugs intended “for use in the cure, mitigation, treatment, or prevention of disease.” Any product marketing itself as such is subject to the agency’s drug approval process.
The letter cited claims from the JÙS By Julie website stating that several of its cold-pressed juices and soups included ingredients that could “fight diabetes,” “lower bad cholesterol,” “control blood pressure” and “offsetting common life disrupting ailments such as depression and ADHD,” among other benefits.
According to FDA rules, the agency must approve the specific language used in any health claims about food or food ingredients preventing disease. The company was given 15 working days from the receipt of the letter to outline specific steps to correct the violations.
The letter also cited JÙS By Julie, which operates a small chain of retail stores in metro New York and also sells products online, for misbranding its Sweet Spin, PB & Jus and Almond Breeze products by not clearly identifying them as juice blends.
In an e-mail to BevNET, Melah explained that JÙS By Julie has responded to the letter and is working with regulatory counsel to ensure its labels and advertising materials are compliant. He wrote, “Changes to our labels have been in the works, and we simply had not made similar changes to our website yet before receiving the warning letter from the FDA. We always strive to be compliant and are excited about continuing to deliver Jus by Julie products to our customers.”
Steven Shapiro of Rivkin Radler LLP, an attorney with extensive experience in food- and drug-related regulatory issues, compared the situation to the FDA’s recent issue of warning letters to 14 U.S.-based companies illegally selling products being fraudulently promoted as cancer treatments.
“The only product that can treat, cure or mitigate diseases are drugs,” he said. “If these products are not approved as drugs, which these are not, then they are unapproved new drugs.”
Shapiro said the FDA is not obligated to send a warning letter ahead of bringing legal action against violators, but noted that the agency often does not pursue litigation if the company agrees to comply with the request in a timely fashion.
He did not observe these types of FDA violations as a prevalent trend within the juice category, simply because most juice products are sold with taste or basic nutrition claims, such as high vitamin C content, rather than promoting the ability to help fight diseases. He said that, assuming evidence exists, JÙS By Julie could instead promote the existence of nutrients that can help maintain the structure and function of the body.
As a more simple rule of thumb, Shapiro advised companies to prioritize staying out of trouble.
“If you’re going to get into the business, you should make sure you have good counsel and know what you’re doing,” he said. “You still need to have competent and reliable science if you are going to say how it affects the body.”