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HomeInspections, Compliance, Enforcement, and Criminal InvestigationsCompliance Actions and ActivitiesWarning Letters2012

Compliance Actions and Activities

Warning Letters2012

Nutrex Research, Inc. 4/24/12  Department of Health and Human ServicesPublic Health Service
Food and Drug Administration 5100 Paint Branch Parkway
College Park, MD 20740

 

April 24, 2012

 


 

 

VIA OVERNIGHT DELIVERY

 

Nutrex Research, Inc.
5707 Dot Com Ct. #1001

Ovideo, FL 32765

 

 

 

Dear Sir or Madam:

 

This letter concerns your products Hemo Rage Black, Lipo-6 Black Ultra Concentrate, Lipo-6 Black, Lipo-6 Black Hers Ultra Concentrate, and Lipo-6 Black Hers, which are labeled and/or promoted as dietary supplements.  The product labeling for Hemo Rage Black, Lipo-6 Black, and Lipo-6 Black Hers declares 1,3- dimethylamylamine HCl as a dietary ingredient, and the product labeling for Lipo-6 Black Ultra Concentrate and Lipo-6 Black Hers Ultra Concentrate declares methylhexaneamine as a dietary ingredient. These two names refer to the same ingredient, which is also called, among other names, dimethylamylamine, DMAA or methylhexanamine, and will be referred to in the rest of this letter as dimethylamylamine.

 

The term "dietary supplement" is defined in 21 U.S.C. 321(ff) [section 201(ff) of the Federal Food, Drug, and Cosmetic Act (the Act)].  Given that you have declared dimethylamylamine as a dietary ingredient in the labeling of your products, we assume you have a basis to conclude that dimethylamylamine is a “dietary ingredient” under 21 U.S.C. 321(ff)(1).  Assuming that dimethylamylamine is a "dietary ingredient," it would also be a “new dietary ingredient” for which a notification is required under 21 U.S.C. 350b(a)(2) and 21 CFR 190.6.

 

Under 21 U.S.C. 350b, a dietary supplement that contains a new dietary ingredient (i.e., a dietary ingredient not marketed in the United States before October 15, 1994) shall be deemed adulterated under 21 U.S.C. 342(f) unless it meets one of two requirements:

 

1. The dietary supplement contains only dietary ingredients that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or

 

2. There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.

 

To the best of FDA’s knowledge, there is no information demonstrating that dimethylamylamine was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is there information demonstrating that this ingredient has been present in the food supply as an article used for food in a form in which the food has not been chemically altered.  In the absence of such information, dimethylamylamine is subject to the notification requirement in 21 U.S.C. 350b(a)(2) and 21 CFR 190.6.  Because the required notification has not been submitted, your products are adulterated under 21 U.S.C. 342(f)(1)(B) and 350b(a).

 

Even if the required notification had been submitted, we know of no evidence that would establish that your product is not adulterated. In the absence of a history of use or other evidence of safety establishing that dimethylamylamine, when used under the conditions recommended or suggested in the labeling of your products, will reasonably be expected to be safe, Hemo Rage Black, Lipo-6 Black Ultra Concentrate, Lipo-6 Black, Lipo-6 Black Hers Ultra Concentrate, and Lipo-6 Black Hers are adulterated under 21 U.S.C. 342(f)(1)(B) and 350b(a) because they contain a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Introduction of such a product into interstate commerce is prohibited under 21 U.S.C. 331(a) and (v). To the best of FDA’s knowledge, there is no history of use or other evidence of safety establishing that dimethylamylamine will reasonably be expected to be safe as a dietary ingredient.  In fact, dimethylamylamine narrows the blood vessels and arteries, which increases cardiovascular resistance and frequently leads to elevated blood pressure. This rise in blood pressure may increase the work of the heart such that it could precipitate a cardiovascular event, which could range from shortness of breath to tightening of the chest and/or a possible myocardial infarction (heart attack).  Therefore, in the absence of a history of use or other evidence of safety establishing that dimethylamylamine is reasonably expected to be safe under the conditions recommended or suggested in the labeling of Hemo Rage Black, Lipo-6 Black Ultra Concentrate, Lipo-6 Black, Lipo-6 Black Hers Ultra Concentrate, and Lipo-6 Black Hers, your products are deemed to be adulterated under 21 U.S.C. 342(f).

 

It has come to our attention that dimethylamylamine used in products in the dietary supplement marketplace may be produced synthetically.  Section 201(ff)(1) of the Act (21 U.S.C. 321(ff)(1)) defines "dietary ingredient" as a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract or combination of any dietary ingredient from the preceding categories.  Synthetically produced dimethylamylamine is not a vitamin, mineral, amino acid, herb or other botanical. To the best of FDA’s knowledge, synthetically produced dimethylamylamine is not commonly used as human food or drink; therefore, it is not a dietary substance for use by man to supplement the diet by increasing the total dietary intake.  Further, synthetically produced dimethylamylamine is not a concentrate, metabolite, constituent, extract or combination of a dietary ingredient.  Therefore, synthetically produced dimethylamylamine is not a dietary ingredient as defined in section 201(ff)(1) of the Act.

 

We request that you take prompt action to correct the violations cited above, as well as any other violations associated with your products Hemo Rage Black, Lipo-6 Black Ultra Concentrate, Lipo-6 Black, Lipo-6 Black Hers Ultra Concentrate, and Lipo-6 Black Hers or other products marketed by your firm that contain dimethylamylamine.  We also remind you that the new dietary ingredient notification requirement applies to all dietary supplements that contain new dietary ingredients that have not been present in the food supply as articles used for food in a form in which the food has not been chemically altered.  It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.

 

Failure to immediately cease distribution of your products Hemo Rage Black, Lipo-6 Black Ultra Concentrate, Lipo-6 Black, Lipo-6 Black Hers Ultra Concentrate, and Lipo-6 Black Hers and any other products you market that contain dimethylamylamine could result in enforcement action by FDA without further notice.  The Act provides for seizure of violative products and injunction against the manufacturers and distributors of violative products.

 

We request that you advise us in writing, within 15 days of receipt of this letter, as to the specific steps that have been or will be taken to correct these violations, including any steps taken with respect to product currently in the marketplace. Your response should also include an explanation of each step taken to assure that similar violations do not recur, as well as documentation to support your response. Your written response should be directed to Latasha Robinson, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions please contact Ms. Robinson at 240-402-1890. 

 

 

Sincerely,
/S/
Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
 

 

-

Page Last Updated: 04/30/2012 
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.


Accessibility Contact FDA Careers FDA Basics FOIA No FEAR Act Site Map Transparency Website Policies

結果 (中文) 1:

   A 到 Z 索引遵循 FDA En Español  HomeFoodDrugsMedical DevicesRadiation 发光 ProductsVaccines、 血液 & BiologicsAnimal & VeterinaryCosmeticsTobacco 产品 检查、 遵守、 执行和刑事调查  HomeInspections、 法规遵从性、 执法，以及刑事 InvestigationsCompliance 的行动和 ActivitiesWarning Letters2012法规遵从性操作和活动警告 Letters2012Nutrex 研究公司 12/4/24 卫生署和人类 ServicesPublic 健康服务食品和药物管理局 5100 油漆分公司大路大学公园，MD 20740 2012 年 4 月 24 日   通过隔夜交货 Nutrex 研究公司5707 点 Com 克拉 # 1001Ovideo，FL 32765   亲爱的先生或女士: 这封信是关于你产品血液愤怒黑色，锂-6 黑色超浓缩，锂-6 黑，锂-6 黑她超集中，，锂-6 黑她，贴上标签和/或促进作为膳食补充剂。产品标签为血液愤怒黑色，锂-6 黑色和锂-6 黑她声明作为一种膳食成分，1，3-dimethylamylamine HCl 和锂-6 黑色超集中和锂-6 黑她超浓缩产品标签声明 methylhexaneamine 作为一种膳食成分。这两个名称是指相同的成分，它也叫做之间其他名称、 dimethylamylamine、 DMAA 或 methylhexanamine，将其余的 dimethylamylamine 作为这封信中提到。 "膳食补充剂"被指在 21 u.s.c.321(ff) [节 201(ff) 的联邦食品、 药品和化妆品法案 (法案)]。既然你已经声明 dimethylamylamine 为在您的产品标签的膳食成分，我们假设你有基础，来得出结论，dimethylamylamine 是"膳食成分"下 21 u.s.c.321(ff)(1)。假设 dimethylamylamine 是"膳食成分"，它也会为此通知要求下 21 u.s.c.350b(a)(2) 和 21 CFR 1 906"新膳食成分"。 以下 21 u.s.c.350b，包含新的膳食成分 (即，不在 1994 年 10 月 15 日之前在美国销售膳食成分) 的膳食补充剂应视为掺假下 21 u.s.c.342(f)，除非它满足两个条件之一: 1.膳食补充剂包含只有目前已在食品供应作为一篇文章，用于在窗体中的食物不被化学改变; 食品的膳食成分或 2.还有的使用历史或其他证据的安全建立将合理预期的膳食成分的推荐或建议在标签膳食补充剂的条件下使用时，为了安全起见，和至少 75 天前被引入或交付为州际贸易，引入制造商或经销商的膳食成分或膳食补充剂为 FDA 提供的信息包括任何引证篇发表的文章，这是的基础的制造商或经销商就结束膳食补充剂含有这种膳食成分将合理预计将安全。 对于最好的 FDA 的知识，没有信息，表明 dimethylamylamine 在 1994 年 10 月 15 日之前, 在美国的膳食成分作为合法销售也不有资料，证明这种成分已经存在于食品供应，作为用于食品的食品已不被化学改变窗体中的一篇文章。由于缺乏这种资料，dimethylamylamine 是 21 u.s.c.350b(a)(2) 和 21 CFR 1 906 的通知规定。因为尚未提交所需的通知，您的产品是掺假下 21 u.s.c.342(f)(1)(B) 和 350b(a)。 Even if the required notification had been submitted, we know of no evidence that would establish that your product is not adulterated. In the absence of a history of use or other evidence of safety establishing that dimethylamylamine, when used under the conditions recommended or suggested in the labeling of your products, will reasonably be expected to be safe, Hemo Rage Black, Lipo-6 Black Ultra Concentrate, Lipo-6 Black, Lipo-6 Black Hers Ultra Concentrate, and Lipo-6 Black Hers are adulterated under 21 U.S.C. 342(f)(1)(B) and 350b(a) because they contain a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Introduction of such a product into interstate commerce is prohibited under 21 U.S.C. 331(a) and (v). To the best of FDA’s knowledge, there is no history of use or other evidence of safety establishing that dimethylamylamine will reasonably be expected to be safe as a dietary ingredient. In fact, dimethylamylamine narrows the blood vessels and arteries, which increases cardiovascular resistance and frequently leads to elevated blood pressure. This rise in blood pressure may increase the work of the heart such that it could precipitate a cardiovascular event, which could range from shortness of breath to tightening of the chest and/or a possible myocardial infarction (heart attack). Therefore, in the absence of a history of use or other evidence of safety establishing that dimethylamylamine is reasonably expected to be safe under the conditions recommended or suggested in the labeling of Hemo Rage Black, Lipo-6 Black Ultra Concentrate, Lipo-6 Black, Lipo-6 Black Hers Ultra Concentrate, and Lipo-6 Black Hers, your products are deemed to be adulterated under 21 U.S.C. 342(f). It has come to our attention that dimethylamylamine used in products in the dietary supplement marketplace may be produced synthetically. Section 201(ff)(1) of the Act (21 U.S.C. 321(ff)(1)) defines "dietary ingredient" as a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract or combination of any dietary ingredient from the preceding categories. Synthetically produced dimethylamylamine is not a vitamin, mineral, amino acid, herb or other botanical. To the best of FDA’s knowledge, synthetically produced dimethylamylamine is not commonly used as human food or drink; therefore, it is not a dietary substance for use by man to supplement the diet by increasing the total dietary intake. Further, synthetically produced dimethylamylamine is not a concentrate, metabolite, constituent, extract or combination of a dietary ingredient. Therefore, synthetically produced dimethylamylamine is not a dietary ingredient as defined in section 201(ff)(1) of the Act. We request that you take prompt action to correct the violations cited above, as well as any other violations associated with your products Hemo Rage Black, Lipo-6 Black Ultra Concentrate, Lipo-6 Black, Lipo-6 Black Hers Ultra Concentrate, and Lipo-6 Black Hers or other products marketed by your firm that contain dimethylamylamine. We also remind you that the new dietary ingredient notification requirement applies to all dietary supplements that contain new dietary ingredients that have not been present in the food supply as articles used for food in a form in which the food has not been chemically altered. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations. Failure to immediately cease distribution of your products Hemo Rage Black, Lipo-6 Black Ultra Concentrate, Lipo-6 Black, Lipo-6 Black Hers Ultra Concentrate, and Lipo-6 Black Hers and any other products you market that contain dimethylamylamine could result in enforcement action by FDA without further notice. The Act provides for seizure of violative products and injunction against the manufacturers and distributors of violative products. We request that you advise us in writing, within 15 days of receipt of this letter, as to the specific steps that have been or will be taken to correct these violations, including any steps taken with respect to product currently in the marketplace. Your response should also include an explanation of each step taken to assure that similar violations do not recur, as well as documentation to support your response. Your written response should be directed to Latasha Robinson, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions please contact Ms. Robinson at 240-402-1890.   Sincerely,/S/Michael W. RooseveltActing DirectorOffice of ComplianceCenter for Food Safetyand Applied Nutrition  -Page Last Updated: 04/30/2012 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.Accessibility Contact FDA Careers FDA Basics FOIA No FEAR Act Site Map Transparency Website Policies

結果 (中文) 3:

  

 

A到Z指数 遵循FDA en espanolñOL

 

 

homefooddrugsmedical devicesradiation发射productsvaccines，血&biologicsanimal&veterinarycosmeticstobacco产品

 

检查，遵守，执行，和刑事调查

  

homeinspections，遵守，执行，和犯罪investigationscompliance行动和activitieswarning letters2012

合规的行为和活动

警告letters2012

Nutrex研究，公司4 / 24 / 12  部卫生和人类服务公共卫生服务
食品和药物管理局 5100油漆 分局大路
学院公园，MD 20740

 

2012年4月24日

 


 

 

通过隔夜交货

 

Nutrex研究，公司
5707点COM CT。
Ovideo#1001
，FL 32765

 

 

 

亲爱的先生或女士：

 

这封信是你的产品血液愤怒黑，黑超浓缩的产品，产品，产品，黑色，黑色，她的超浓缩，服用黑她的，这是标记和/或作为膳食补充剂。 产品血液愤怒的黑色，黑色，黑色的产品标签，产品，她宣称1,3-二甲戊胺盐酸作为膳食成分，和产品的产品，黑超浓缩和锂-6黑色她的超浓缩是甲基己胺作为膳食成分标识。 这两个名字指的是相同的成分，也就是所谓的，其他的名字，二甲戊胺中，DMAA或methylhexanamine，将提到的这封信二甲戊胺休息。

 

“膳食补充剂”的定义21 U.S.C. 321（FF）[第201（FF）的联邦食品，药品，化妆品法（行为）]。 给你宣布你的产品二甲戊胺作为标记的膳食成分，我们假定你已经得出结论，二甲戊胺基是一“饮食成分”，根据21 U.S.C. 321（FF）（1）。 假设二甲戊胺是一种“饮食成分，这也将是一个“新膳食成分”的通知是根据21 U.S.C. 350b要求（一）（2）和21 CFR 190.6。

 

21 U.S.C. 350b，膳食补充剂含有新膳食成分（即，膳食成分不在美国市场销售的十月十五日之前，1994）应被视为掺假根据21 U.S.C. 342（F）除非它满足一个要求：

 

1。 膳食补充剂只含有膳食成分已经在食品供应作为一个形式的食品没有发生化学变化的食品用的物品；或

 

2。 有使用或安全建立的条件下使用时推荐或在膳食补充剂标签建议将应该是安全和膳食成分，其他证据的历史，至少75天之前被介绍或交州际贸易，的膳食成分或饮食补充提供FDA信息生产商或经销商，包括任何引用发表的文章，这是基础，制造商或经销商认为膳食补充剂含有的膳食成分将应该是安全的。

 

据FDA的知识，没有信息表明二甲戊胺是合法销售作为膳食成分在美国在1994年10月15日之前，也没有信息表明这种成分已在食品供应作为一个形式的食品没有发生化学变化的食品用品。 在没有这样的信息，二甲戊胺在21 U.S.C. 350b受通知的要求（一）（2）和21 CFR 190.6。 因为要求通知尚未提交，你是掺假产品，根据21 U.S.C. 342（f）（1）（b）和350B（一）。

 

即使已提交通知要求，我们知道，没有证据可以证明你的产品是不掺假。 中使用或安全的建立，二甲戊胺其他证据历史缺失的条件下使用时，推荐或你的产品标签建议，将应该是安全的， 血怒黑，黑超浓缩的产品，产品，产品，黑色，黑色，黑色的超浓缩的产品，她，她的掺假根据21 U.S.C.342（f）（1）（b）和350b（一）因为它们含有一种新的膳食成分，有足够的信息，提供合理的保证，这样的成分不明显或者不明显的疾病或损伤的风险。 推出这样一个产品进入州际贸易是根据21 U.S.C. 331禁止（A）和（V）。 据FDA的知识，没有使用或安全的建立，二甲戊胺将应该是安全的膳食成分的其他证据  历史。事实上，二甲戊胺变窄的血管和动脉，从而增加血管阻力，导致血压升高。 这种上升的血压可能会增加的心脏，它可能导致心血管事件的工作，能够从呼吸急促的胸部和/或心肌梗死范围可能收紧（心脏病发作）。 因此，