Rishi Tea on Wednesday removed website health claims for several of its teas following a Federal Drug Administration complaint.
In its warning letter the FDA concluded that Rishi had promoted the teas as drugs. All products that claim a use in the treatment, cure or prevention of disease are strictly regulated. In his letter of April 20 the FDA’s Minneapolis District Director, Gerald J. Berg, also cautioned Rishi about its use of nutrient content in its descriptions and use of the term “antioxidant” in connection with several teas.
Benjamin Harrison, co-owner and vice president of sales, says Rishi’s claims are substantiated by eastern medicine, academic research and clinical studies. “We respect the fact that the FDA does not recognize this body of work,” said Harrison. But that disagreement will not interfere with the firm’s immediate compliance, he said.
Several offerings from the company’s web store were named including oolong green tea and Pu-erh teas, a ginger organic botanical and tealeaf powder.
Berg wrote that since these teas are not GRAS (generally recognized as safe) for the marketed uses, they are considered “new drugs" under section 201(p) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 321(p). New drugs may not be legally marketed in the United States without prior approval from FDA.
The warning likely will impact other retailers and tea manufacturers.
“Companies should be vetted and claims should be analyzed,” said Harrison. It was never Rishi’s intent to promote its products as drugs, he said: “We don’t state or imply anything beyond the fact these are food and beverage products.”
“No one has been accused of being dishonest, these are clear and straightforward claims supported by professional and academic research and a considerable amount of tea science and study that we have accessed and analyzed throughout our years of direct trade with our partners in Asia,” he explained.
“We recognize the FDA does not recognize this research at this time and we will make sure there are no further discrepancies with their guidelines,” said Harrison.
In 2008 FDA issued a non-binding guidance regarding antioxidant claims and last August the FDA warned Lipton Tea and Canada Dry to avoid claims similar to those by Rishi. FDA officials have declared a low tolerance for marketing that exaggerates the health benefit of food and drink following a large influx of functional and fortified foods and beverages.
Lipton’s website promotions identified four studies that showed a cholesterol-lowering effect with tea. FDA concluded the description suggests Lipton tea is designed to treat or prevent disease.
The makers of Canada Dry Sparkling Green Tea Ginger Ale were warned that claims that the drink is "enhanced with 200 mg of antioxidants from green tea and vitamin C" are not nutrients “with recognized antioxidant activity."
Unilever and the Dr. Pepper Snapple Group that manufactures Canada Dry products complied with the FDA’s request.