Inspections, Compliance, Enforcement, and Criminal Investigations
Diaspora Tea & Herb dba Rishi Tea 4/20/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Minneapolis District Office|
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
April 20, 2011
RETURN RECEIPT REQUESTED
Refer to MIN 11 – 21
President and Co-owner
Diaspora Tea & Herb Co., LLC
427 East Stewart Street
Milwaukee, Wisconsin 53207
Dear Mr. Kaiser:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.rishi-tea.com/store/index.php in January 2011. FDA has determined that your Oolong Tea, Ginger, Organic Botanical, Green Oolong Tea, 100% Premium Tealeaf Powder, and Pu-erh Tea 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. Additionally, FDA has determined that your 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). The marketing of these products with these claims violates the Act. You can find copies of the Act through links on FDA’s home page at http://www.fda.gov.
I. Unapproved New Drugs
Examples of disease claims on your website http://www.rishi-tea.com/store/
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 is…prized for its cholesterol reducing….”
Your Oolong Tea, Ginger, Organic Botanical, Green Oolong Tea, 100% Premium Tealeaf Powder and Pu-erh Tea products are not generally recognized as safe and effective for the above referenced uses and, therefore, are also “new drugs” under section 201(p) of the Act, 21 U.S.C. § 321(p). New drugs may not be legally marketed in the U.S. without prior approval from FDA, as described in section 505(a) of the Act, 21 U.S.C. § 355(a). FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
II. Unauthorized Nutrient Content Claims
Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation promulgated by the Secretary (and, by delegation, FDA) authorizing the use of such a claim. Characterizing the level of a nutrient in food labeling of a product without complying with specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the 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, your website bears “high” and “rich in” nutrient content claims about nutrients for which there are no established DV.
The following are examples of unauthorized “high” and “rich in” nutrient content claims on your website:
• “[R]ich in Tea Polyphenols and Theaflavins…rich in Thearubigin and Theabrownin….”
Super Green, Organic Japanese Green Tea
• “Super Green is…high in amino acids….”
• “White Tea…contain[s] high concentrations of…L-Theanine Amino Acid.”
Additionally, your 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.
The following are examples of nutrient content claims on your website that use the term “antioxidant” but do not include the names of the nutrients that are the subject of the claim as required under 21 CFR 101.54(g)(4):
Yerba Maté Shade Grown, Organic Yerba Maté
• “Yerba Maté is…rich in… antioxidants.”
Blueberry Rooibos, Organic Fair Trade Rooibos Blend
Green Rooibos (Green Bush), Organic Fair Trade Botanical
• “Caffeine-free Green Rooibos…contain[s] high concentrations of antioxidants….”
Additionally, the following are examples of nutrient content claims on your website that use the term “antioxidant,” but where the nutrients that are the subject of the claim do not have an established RDI as required under 21 CFR 101.54(g)(1):
• “White Tea… contain[s] high concentrations of… antioxidant polyphenols (tea catechins)….”
Matcha, 100% Premium Tea Powder
• “Antioxidant rich…222mg polyphenols per serving!”
Genmai Green Tea, 100% Premium Tealeaf Powder
• “Antioxidant rich…65mg polyphenols per serving!”
Green Oolong Tea, 100% Premium Tealeaf Powder
• “Antioxidant rich…109mg polyphenols per serving!”
• “[R]ichest sources of flavonoid antioxidants….”
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We urge you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products, 21 U.S.C. §§ 332 and 334. You should take prompt action to correct these violations and prevent their future recurrence. Failure to do so may result in enforcement action without further notice.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations. You should include in your response documentation such as revised labels or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when you will correct any remaining violations.
Your reply should be sent to the attention of Compliance Officer Tyra S. Wisecup at the address on the letterhead.
Gerald J. Berg