April 26, 2011
MINNEAPOLIS, Minn.FDA warned Diaspora Tea & Herb Co. LLC that some of its Rishi Teas were promoted for conditions that cause them to be considered drugs. In an April 20 letter from Gerald J. Berg, director, FDAs Minneapolis District Office, the agency said Rishi Teas website promots Oolong Tea, Ginger, Organic Botanical, Green Oolong Tea, 100% Premium Tealeaf Powder and Pu-erh Tea as 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 letter was issued to Joshua Kaiser, president and co-owner, Diaspora Tea & Herb Co., and said the Internet claims establish these products as drugs because they were described as intended for use in the cure, mitigation, treatment or prevention of disease.
Additionally, FDA determined that Diaspora Tea & Herb Co.s Yerba Maté Shade Grown, Organic Yerba Maté, White Tea, Pu-erh Tea, Green Oolong Tea, 100% Premium Tealeaf Powder, Matcha, 100% Premium Tea Powder, Blueberry Rooibos, Organic Fair Trade Rooibos Blend, Green Rooibos (Green Bush), Organic Fair Trade Botanical and Super Green, Organic Japanese Green Tea products are also misbranded within the meaning of section 403(r)(1)(A) of the Act, 21 U.S.C. § 343(r)(1)(A).
FDA took issue with the following claims from the Rishi Tea website:
Ginger, Organic Botanical:
[G]inger is used in food and drinks as a preventive medicine against colds [and] flus."
Green Oolong Tea, 100% Premium Tealeaf Powder:
The powerful antioxidants found in tea are believed to help prevent cancer [and] lower cholesterol."
Recent research suggests that consuming 5-8 cups of Pu-erh Tea each day can reduce cholesterol and plaque of the arteries."
Regular consumption of Oolong Tea is linked to the reduction of plaque in the arteries, reduction of cholesterol and lowering of blood sugar."
Oolong Tea isprized for its cholesterol reducing."
Because Oolong Tea, Ginger, Organic Botanical, Green Oolong Tea, 100% Premium Tealeaf Powder and Pu-erh Tea products are not GRAS (generally recognized as safe) for the marketed uses and, FDA said they are considered new drugs" under section 201(p) of the Act, 21 U.S.C. § 321(p). New drugs may not be legally marketed in the United States without prior approval from FDA, as described in section 505(a) of the Act, 21 U.S.C. § 355(a).
FDA said Rishi Teas site declared unauthorized nutrient content claims under section 403(r)(1)(A) of the Unauthorized Nutrient Content Claims Act. Nutrient content claims that use the defined terms rich in" or high" may be used in the labeling of a food only if the food contains 20 percent or more of the daily value (DV) of that nutrient per reference amount customarily consumed (RACC), Title 21, Code of Federal Regulations (21 CFR), 101.54(b)(1). Such claims may not be made about a nutrient for which there is no established DV. However, the website claims Pu-erh Tea is [R]ich in Tea Polyphenols and Theaflavinsrich in Thearubigin and Theabrownin.;" Super Green, Organic Japanese Green Tea is high in amino acids.;" and White Tea contains high concentrations ofL-Theanine Amino Acid."
Further, the website bears nutrient content claims using the term antioxidant." Nutrient content claims using the term antioxidant" must also comply with the requirements listed in 21 CFR 101.54(g). These requirements state, in part, that for a product to bear such a claim, a recommended daily intake (RDI) must have been established for each of the nutrients that are the subject of the claim, 21 CFR 101.54(g)(1), and these nutrients must have recognized antioxidant activity, 21 CFR 101.54(g)(2). The level of each nutrient that is the subject of the claim must also be sufficient to qualify for the claim under 21 CFR 101.54(b), (c), or (e), 21 CFR 101.54(g)(3). Such a claim must also include the names of the nutrients that are the subject of the claim as part of the claim or, alternatively, the term antioxidant" or antioxidants" may be linked by a symbol (e.g., an asterisk) that refers to the same symbol that appears elsewhere on the same panel of the product label, followed by the name or names of the nutrients with recognized antioxidant activity, 21 CFR 101.54(g)(4). The use of a nutrient content claim that uses the term antioxidant," but does not comply with the requirements of 21 CFR 101.54(g) misbrands a product under section 403(r)(2)(A)(i) of the Act. Rishi uses the following antioxidant nutrient contact claims without naming the specific nutrients: Yerba Maté isrich in antioxidants;" Blueberry Rooibos, Organic Fair Trade Rooibos Blend is Antioxidant-rich.;" and Caffeine-free Green Rooiboscontain[s] high concentrations of antioxidants." Additionally, FDA noted Rishis website used the term antioxidant" whith nutrients that not have an established RDI: White Tea contain[s] high concentrations of antioxidant polyphenols (tea catechins).;" Matcha, 100% Premium Tea Powder is Antioxidant rich222mg polyphenols per serving!;" Genmai Green Tea, 100% Premium Tealeaf Powder is Antioxidant rich65mg polyphenols per serving!;" and Green Oolong Tea, 100% Premium Tealeaf Powder is Antioxidant rich109mg polyphenols per serving!," and the [R]ichest sources of flavonoid antioxidants."
FDA urged the company to review its website, product labels, and other labeling and promotional materials for your products to ensure claims do not cause them to violate the Act, and said failure to correct the claims may result in the seizure of illegal products as well as injunctions against manufacturers and distributors of those products, 21 U.S.C. §§ 332 and 334.
Diaspora Tea & Herb Co. has 15 working days from the receipt of the letter to respond in writing with an outline of the specific actions the company is taking to correct these violations and to prevent similar violations.
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