(':~ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Transcription

1 (':~ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service,~«-, :N'R Mr. Kevin J. Asay 333 West River Park Drive Dear Mr. Asay: This is in response to your letters dated April 12, 2010 to the Food and Drug Administration (FDA) pursuant to 21 US.C. 343(r)(6) (section 403(r)(6) ofthe Federal Food, Drug, and Cosmetic Act (the Act» for the products Tahitian Noni Original Bioactive Beverage, Tahitian Noni Extra Bioactive Beverage, Tahitian Noni Family Bioactive Beverage (Grape and Mango Passionfruit flavors), and Tahitian Noni Pure Bioactive Beverage. 21 US.C. 321(ff) defines the term "dietary supplement." As defined by the Act, a dietary supplement does not include a product represented for use as a conventional food or as a sole item ofa meal or the diet (21 U.S.C. 321(fI)(2)(B». The products identified above appear to be represented for use as conventional foods, namely they are promoted as beverages (e.g., they are identity labeled using the term "beverage"). Beverages are conventional foods. Therefore, in that they appear to be represented for use as conventional foods (Le., as beverages), they do not appear to be dietary supplements within the meaning of21 U.S.C. 321(fl) and claims made for them are not subject to 21 U.S.C. 343(r)(6). Instead, these products appear to be conventional foods that must meet the regulatory requirements that apply to conventional foods rather than those requirements that apply to dietary supplements. Briefly, they must bear nutrition labeling in accordance with 21 CFR and claims may be made for the products in their labeling ifthey are claims definedby21 U.S.C. 343(r)(1)0r21 U.S.C. 321 (g)(i)(c) that maybe made for conventional foods. Additionally, under the Act, any ingredient intentionally added to a conventional food must be used in accordance with a food additive regulation unless it is generally recognized as safe (GRAS) among qualified experts for its intended use in food. Use ofa food ingredient that is not GRAS or an approved food additive causes a food to be adulterated under 21 US.C. 342(a)(2)(C) and cannot be legally marketed in the US. Ifyou intend to market this product as a conventional food and you have any questions about the status ofany ofits ingredients, you should direct them to FDA's Office offood Additive Safety (HFS-200), 5100 Paint Branch Parkway,. LET

2 Page 2 - Mr. Kevin J. Asay Please contact us ifyou require further assistance. Sincerely yours, Robert J. Moore, Ph.D. Supervisor, Regulations hnplementation Team Division ofdietary Supplement Programs Office ofnutrition, Labeling and Dietary Supplements Center for Food Safety and Applied Nutrition Copies: FDA, Center for Drug Evaluation and Research, Office ofcompliance, HFD-31 0 FDA, Office ofthe Associate Commissioner for Regulatory Affairs, Office of Enforcement, HFC-200 FDA, Denver District Compliance, HFR-SW240

3 Tell the Story~ 12 April 2010 Office of Nutritional Products Labeling and Dietary Supplements (HFS-81 0) To Whom It May Concern: In accordance with the requirements ofsection 6 ofthe Dietary Supplement Health and Education Act of 1994, and 21 CFR lol.93, your agency is hereby notified that has made the following structure functions statements for a dietary supplement product as follows 333 West River Park Dr. Statements made: Tahitian Noni Original Bioactive Beverage enhances the immune system. Tahitian Noni Original Bioactive Beverage boosts energy naturally. Tahitian Noni Original Bioactive Beverage promotes/supports heart health. Tahitian Noni Original Bioactive Beverage strengthens and balances the whole body. Tahitian Noni Original Bioactive Beverage neutrali;res free radicals. Powerful Bioactives - Noni is full of natural bioactives that protect cells in the body. Dynamic iridoids - The main bioactives in noni are iridoids, powerful compounds that deliver numerous health benefits Versatile Adaplogen - Noni is a powerful adaplogen-the ultimate smart supplement that improves the body's ability to maintain health. Tahitian Noni Original is packed full of iridoids and other powerful bioactives that will make you healthier. Tahitian Noni Original provides 30 mg ofbioactive iridoids per 60 ml serving as well as more than 150 nutrientsincluding various vitamins, minerals, and antioxidants - that all help to contribute to a healthier body. Name of Dietary Supplement Tahitian Noni Original Bioactive Beverage The undersigned certifies on behalfof that the infonnation presented and contained in this correspondence is complete and accurate. 333 \Xest River Park Dr. P.O. Box 4000 Orem, UT I PHONE: I FAX: I

4 Tell the Story ]2 April 2010 Office of Nutritional Products Labeling and Dietary Supplements (HFS-81 0) To Whom It MayConcem: In accordance with the requirements ofsection 6 of the Dietary Supplement Health and Education Act of 1994, and 21 CFR , your agency is hereby notified that has made the following structure functions statements for a dietary supplement product as follows 333 West River Park Dr. Statements made:. Tahitian Noni Extra Bioactive BeverageTM boosts energy and endurance. Tahitian Noni Extra Bioactive BeverageTM improves joint health. Tahitian Noni Extra Bioactive Beverage speeds recovery time. Tahitian Noni Extra Bioactive BeverageTM promotes heart health. Tahitian Noni Extra Bioactive BeverageTM enhances the immune system. Tahitian Noni Extra Bioactive Beverage replenishes and restores-putting back in what life takes out. Tahitian Noni Extra Bioactive BeverageTM protects DNA. Powerful Bioactives - Noni is full of natural bioactives that protect cells in the body. Dynamic iridoids The main bioactives in noni are iridoids, powerful compounds that deliver numerous health benefits Versatile Adaptogen - Noni is a powerful adaptogen-the ultimate smart supplement that improves the body's ability to maintain health. Name of Dietary Supplement Tahitian Noni Extra Bioactive Beverage The undersigned certifies on behalfof that the information presented and contained in this correspondence is complete and accurate KeVin J. Asay Managing Director of Regulat 333 ~st River Park Dr. I P.O. Box 4000 Orem, UT I PHONE: I FAX: I

5 Tell the Story 12 April 2010 Office of Nutritional Products Label ing and Dietary Supplements (HFS-8] 0) To Whom It MayConcem: In accordance with the requirements of section 6 ofthe Dietary Supplernent Health and Education Act of ]994, and 2] CFR ] 01.93, your agency is hereby notified that has made the following structure functions statements for a dietary supplement product as follows 333 West River PaIt Dr. Statements made: Tahitian Noni Family Bioactive BeverageTM supports/enhances the immune system. Tahitian Noni Family Bioactive Beverage neutralizes free radicals. Tahitian Noni Family Bioactive Beverage boosts energy naturally. Tahitian Noni Family Bioactive Beverage strengthens and balances the whole body. Tahitian Noni Family Bioactive BeverageTM promotes cell protection. Since noni is a natural adaptogen, it will keep you and your family at optimal health in a wide array of categories. Powerful Bioactives - Noni is full of natural bioactives that protect cells in the body. Dynamic iridoids - The main bioactives in noni are iridoids, powerful compounds that deliver numerous health benefits Versatile Adaptogen - Noni is a powerful adaptogen-the ultimate smart supplement that improves the body's ability to maintain health. The main bioactives in noni are iridoids, powerful compounds that deliver numerous health benefits. Tahitian Noni Family provides] 5 mg of bioactive iridoids per 60 ml serving as well as more than] 50 nutrients including various vitamins, minerals, and antioxidants - that all help to contribute to a healthier body. Name of Dfetary Supplement Tahitian Noni Family Bioactive Beverage in Grape and Mango Passionftuit flavors The undersigned certifies on behalf of that the information presented and contained in this correspondence is complete and accurate Kevin J. Asay Managing Director of Regul Affairs 333 ~st River Park Dr. I P.O. Box 4000 Drem, UT I PHONE: I FAX: I

6 Tell the Story 12 April 2010 Office ofnutritional Products Labeling and Dietary Supplements (HFS-81 0) To Whom It May Concern: In accordance with the requirements ofsection 6 ofthe Dietary Supplement Health and Education Act of 1994, and 21 CFR , your ag~cy is hereby notified that has made the foliowing structure functions statements for a dietary supplement product as follows 333 West River Park Dr. Statements made: Tahitian Noni Pure Bioactive Beverage is straight-from-the-source support for your heart, joints, and immune system. Name of Dietary Supplement Tahitian Noni Pure Bioactive Beverage TM The undersigned certifies on behalf of that the information presented and contained in this correspondence is complete and accurate Kevin J. Asay Managing Director ofregul 333 ~st River Park Dr. I P.O. Box 4000 Orem, UT 840S PHONE: I FAX: I