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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Formulife, Inc. 6/17/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128

 

June 17, 2013
 
2013-DAL-WL-38
 
WARNING LETTER
 
 
UPS OVERNIGHT MAIL
 
Brandon M. Smith, Owner and President
Formulife, Inc.
Purus Labs, Inc.
11370 Pagemill Rd.
Dallas, TX 75243
 
Dear Mr. Smith:
 
From August 1 through September 11, 2012, the U.S. Food and Drug Administration (FDA) inspected your dietary supplement facility located at 11370 Pagemill Rd., Dallas, Texas. During the inspection our investigator noted that you distribute dietary supplements that declare 2-amino-4-methylhexane as a dietary ingredient, including “Fat Smack XR Thermolipolytic”, “Muscle Marinade® Fresh Fruit”, and “Muscle Marinade® Cherry Limeade”. This ingredient is also called, among other names, dimethylamylamine, 1,3‑dimethylamylamine, DMAA, or methylhexanamine, and will be referred to in the rest of this letter as dimethylamylamine.  As explained below, dimethylamylamine is not a dietary ingredient. Rather, it is an unsafe food additive that causes your dimethylamylamine-containing products to be adulterated under section 402(a)(2)(C) of the Federal Food Drug and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(2)(C)]. The distribution of these products in interstate commerce is also prohibited under section 301(ll) of the Act [21 U.S.C. § 331(ll)] because they are foods to which dimethylamylamine, a drug approved under section 505 of the Act (21 U.S.C. § 355), has been added. 
 
In addition, we have reviewed the labeling for your D-Pol product, including the product label and your website at www.puruslabs.net. Based on our review, we have concluded that D-Pol is in violation of sections 403, 505(a), and 502(f)(1) of the Act [21 U.S.C. §§ 343, 355(a), and 352(f)(1)] and regulations implementing the dietary supplement labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101).
 
We have also reviewed the labeling for your Muscle Marinade Cherry Limeade, Muscle Marinade Fresh Fruit, SLINshot, Condense, Recycle, and Fat Smack XR Thermolipolytic products. Based on our review, we have concluded that these products are in violation of section 403 of the Act [21 U.S.C. §343] and regulations implementing the dietary supplement labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find the Act and FDA regulations through links in FDA’s website at www.fda.gov.
 
Products containing dimethylamylamine
 
Your products “Fat Smack XR Thermolipolytic”, “Muscle Marinade® Fresh Fruit”, and “Muscle Marinade® Cherry Limeade”, are labeled and promoted as dietary supplements. The labels of these products declare dimethylamylamine as a dietary ingredient under the name “2-amino-4-methylhexane.” FDA does not agree that dimethylamylamine is a dietary ingredient as defined in section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)]. 
  
At least one distributor of dietary supplements containing dimethylamylamine has argued that dimethylamylamine is a dietary ingredient under section 201(ff)(1) of the Act because: (1) it is a constituent of a botanical, namely the geranium Pelargonium graveolens, under section 201(ff)(1)(C) and (F); and (2) it is a dietary substance for use by man to supplement the diet by increasing total dietary intake, under section 201(ff)(1)(E).  FDA disagrees with both of these assertions.  Dimethylamylamine does not qualify as a dietary ingredient under section 201(ff)(1)(C) or 201(ff)(1)(F) because dimethylamylamine is not an herb or other botanical, nor is it a constituent of a botanical.  Although some marketers of dimethylamylamine products have asserted that dimethylamylamine is present as a constituent of the geranium P. graveolens, FDA has reviewed the scientific literature on this subject and has concluded that the totality of the scientific evidence does not demonstrate the presence of DMAA in P. graveolens.[1] Therefore, dimethylamylamine is not a constituent of P. graveolens that could qualify as a dietary ingredient under section 201(ff)(1)(F). 
 
Additionally, dimethylamylamine does not qualify as a dietary ingredient under section 201(ff)(1)(E) of the Act because, to the best of FDA’s knowledge, no evidence exists that dimethylamylamine is a dietary substance for use by man to supplement the diet by increasing total dietary intake.  Because the scientific evidence does not demonstrate the presence of dimethylamylamine as a constituent of geraniums, the possibility that geraniums may have been consumed as a food or drink by humans does not demonstrate that dimethylamylamine is a dietary substance.  Further, to the best of FDA’s knowledge, dimethylamylamine itself is not commonly used as a food or drink by humans. 
 
Finally, dimethylamylamine does not qualify as a dietary ingredient under any other prong of section 201(ff)(1) of the Act. Dimethylamylamine is not a vitamin, mineral, amino acid, herb, or other botanical.  Moreover, to the best of FDA’s knowledge, dimethylamylamine is not a concentrate, metabolite, constituent, extract, or combination of any dietary ingredient.  
 
If a substance is not generally recognized as safe (GRAS) by qualified experts for its intended use in food and does not qualify for any of the other exemptions from the food additive definition,[2]it is a food additive. Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe and causes the food to be adulterated under section 402(a)(2)(C) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)]. Adulterated foods cannot be legally imported or marketed in the United States.
 
Section 201(s) of the Act [21 U.S.C. § 321(s)] exempts dietary ingredients used in dietary supplements from the food additive definition. However, non-dietary ingredients intended for use in dietary supplements, such as the dimethylamylamine used in your products, are not exempt from the food additive definition and must meet the same requirements as substances added to conventional foods. In other words, a non-dietary ingredient added to a dietary supplement must be used in accordance with a food additive regulation or be GRAS for its intended use, unless it qualifies for another exception to the food additive definition.
 
Dimethylamylamine is not generally recognized as safe under its conditions of use in your dietary supplement products. In fact, dimethylamylamine is known to have cardiovascular risks. It 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).  Because dimethylamylamine does not qualify as a dietary ingredient and is not GRAS or otherwise exempt from the food additive definition, your dimethylamylamine-containing products “Fat Smack XR Thermolipolytic”, “Muscle Marinade® Fresh Fruit”, and “Muscle Marinade® Cherry Limeade” products are adulterated under section 402(a)(2)(C) of the Act [21 U.S.C. § 342(a)(2)(C)] because they contain an unsafe food additive. 
 
The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act under section 301(a) of the Act [21 U.S.C. § 331(a)]. Further, it is a prohibited act under section 301(ll) of the Act [21 U.S.C. § 331(ll)] to introduce or deliver for introduction into interstate commerce any food to which a drug approved under section 505 of the Act [21 U.S.C. § 355] has been added, unless the added drug was marketed in food before being approved under section 505.[3]® Fresh Fruit”, and “Muscle Marinade® Cherry Limeade” products are in violation of section 301(ll) of the Act. Dimethylamylamine was approved as a drug in 1948 under section 505 of the Act and, to the best of FDA’s knowledge, was not marketed in food prior to such approval, either on its own or based on its alleged presence as a component of P. graveolens.  In the absence of such evidence, your “Fat Smack XR Thermolipolytic”, “Muscle Marinade
 
Failure to immediately cease distribution of your products “Fat Smack XR Thermolipolytic”, “Muscle Marinade® Fresh Fruit”, and “Muscle Marinade® Cherry Limeade” and any other products you market that contain dimethylamylamine could result in enforcement action by FDA without further notice.  
 
Unapproved New Drug Violations
 
Your website,www.puruslabs.net, promotes your D-Pol product for conditions that cause it to be a drug under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)]. The therapeutic claims on your website establish that this product is a drug because it is intended for use in the cure, mitigation, treatment or prevention of disease.  
 
For example, claims found in the D-Pol “White Paper” regarding the ingredient nitrate include:
 
  • “nitrate supplementation has been reported to lower blood pressure in humans…”
  • “Dietary nitrate has been reported to prevent endothelial dysfunction induced by an acute ischemic insult…”
  • “blood pressure lowering effect of dietary nitrate.”
  • “…a slight reduction in blood pressure is correlated to a lower risk of cardiovascular disease.”
 
Your D-Pol product is not generally recognized as safe and effective for the above referenced uses and therefore, it is a “new drug” 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. 
 
Furthermore, because D-Pol is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions for use cannot be written so that a layperson can use the drug safely for its intended uses. Thus, the labeling fails to bear adequate directions for use, causing D-Pol to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction of misbranded drugs into interstate commerce is a violation of § 301(a) of the Act [21 U.S.C. § 331(a)].
 
Food Misbranding Violations
 
Even if your website did not contain claims for your D-Pol product that cause it to be an unapproved new and misbranded drug, it would still be a misbranded dietary supplement under section 403 of the Act [21 U.S.C. § 343], as are your Muscle Marinade Cherry Limeade, Muscle Marinade Fresh Fruit, SLINshot, Condense, Recycle, and Fat Smack XR Thermolipolytic products, in that the labeling for these products does not comply with the food labeling requirements in 21 CFR Part 101, as follows:
 
1.  Your products SLINshot, Condense, D-Pol, and Fat Smack XR Thermolipolytic are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they contain ingredients that are not declared on the label, or are not declared using the common or usual name of the ingredient, as required by 21 CFR 101.4:
 
·         Your SLINshot product is encapsulated, but the capsule ingredients are not listed in your ingredient statement.
 
·         Your Fat Smack XR Thermolipolytic two-capsule sample size packet label does not contain an ingredient statement.
 
·         Your Condense and D-Pol products declare the dietary ingredient, NitrateneTM, which is not the common or usual name of the ingredient.
 
2.   Your products Muscle Marinade Cherry Limeade, Muscle Marinade Fresh Fruit, Fat Smack XR, SLINshot, and D-Pol are misbranded under section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically,
 
·         According to 21 CFR 101.36(b)(2)(i), any dietary ingredients that have a Reference Daily Intake (RDI) or a Daily Reference Value (DRV) as established in 21 CFR 101.9(c) and their sub-components (hereinafter referred to as “(b)(2)-dietary ingredients”), that is, total calories, calories from fat, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium and iron shall not be declared when they are not present or are present in amounts that can be declared as zero in 21 CFR 101.9(c). However, your Muscle Marinade Cherry Limeade label declares Daily Values of calories, total fat, cholesterol, total carbohydrate, and sugar as “0%.”
 
·         According to 21 CFR 101.36(b)(2)(i)(A), the names and the quantitative amounts by weight of each (b)(2)-dietary ingredient shall be presented under the heading "Amount Per Serving." However, your Muscle Marinade Cherry Limeade, SLINshot, and D-Pol product labels do not bear this heading, but instead include the heading “Ingredient,” which is not permitted under 21 CFR 101.36.
 
·         Your declaration of proprietary ingredients on your Muscle Marinade Cherry Limeade and Muscle Marinade Fresh Fruit labels does not meet the requirements in 21 CFR 101.36(c)(1) which states that dietary ingredients contained in the proprietary blend that are listed under paragraph (b)(2) of 21 CFR 101.36 shall be declared in accordance with that paragraph. However, your label lists several (b)(2) ingredients such as vitamin C and sodium twice on your Supplement Facts panel.
 
·         Your D-Pol and Muscle Marinade labels do not meet the requirements under 21 CFR 101.36(c)(2) because the dietary ingredients contained in your proprietary blends are not indented under the term “Proprietary Blend” or other appropriately descriptive term or fanciful name.
 
 
3.  Your SLINshot and Recycle labels are misbranded within the meaning of section 402(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because your products contain botanical ingredients but do not identify the plant part from which the ingredient is derived. Specifically, your product labels declare the presence of botanical ingredients but do not declare the part of the plant from which the botanical is derived in accordance with 21 CFR 101.4(h)(1).
 
The above list is not intended to be an all-inclusive list of deficiencies with your products, labels, and labeling. It is your responsibility to ensure that your establishment is in compliance with all requirements of the Act and federal regulations. You should take prompt measures to correct all violations described in this letter. Failure to take appropriate corrective action may result in regulatory action being initiated by FDA without further notice, such as injunction or seizure.
 
We also have the following comments:
 
1.      Your Muscle Marinade Cherry Limeade and SLINshot product labels fail to declare quantitative amounts by weight per serving of other dietary ingredients using metric measures in appropriate units (i.e., 1,000 or more units shall be declared in the next higher set of units, e.g. 1,100 mg shall be declared as 1.1 g) in accordance with 21 CFR 101.36(b)(3)(ii)(A). These labels bear amounts such as “1000 mg” and “10500 mg” which should be declared as 1.0 g and 10.5 g, respectively. 
 
2.    Your Muscle Marinade Cherry Limeade label declares potassium present at “1%” of the Daily Value; however, according to 21 CFR 101.9(c)(8)(iii), the percentages for vitamins and minerals shall be declared in increments of 2% up to and including the 10-percent level.
 
3.    Your Condense product label should include the words “Net Weight” before the weight declaration on your principal display panel, in accordance with 21 CFR 101.105(j)(3).
 
4.    The label for Muscle Marinade Cherry Limeade includes the "other ingredient list" inside the nutrition label. This placement is not in accordance with 21 CFR 101.4(g) because these ingredients should be listed outside the supplement facts label and immediately below it or immediately contiguous and to the right.
 
You should notify this office in writing within fifteen (15) working days from your receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions or steps towards long term corrective actions. If you cannot complete all corrective actions before you respond, you should explain the reason for your delay and state when you will correct the remaining deficiencies.    
 
Please submit your response to Seri Essary, Compliance Officer, at the above letterhead address. If you have any questions please contact Ms. Essary at (214)253-5335.
 
 
 
Sincerely,
/S/ 
Reynaldo R. Rodriguez, Jr.
Dallas District Director


[1] FDA’s review of the scientific literature on this topic is summarized in a letter to USPlabs, LLC, dated April 18, 2013. The letter is posted on the agency’s website at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CFSAN/CFSANFOIAElectronicReadingRoom/ucm350199.htm.
 
 
[2] Under section 201(s) of the FD&C Act [21 U.S.C. § 321(s)], the following types of substances are excluded from the food additive definition: (1) pesticide chemical residues in or on a raw agricultural commodity or processed food; (2) pesticide chemicals; (3) color additives; (4) substances used in accordance with a “prior sanction” (i.e., a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 under the FD&C Act, the Poultry Products Inspection Act, or the Meat Inspection Act; (5) new animal drugs; and (6) dietary ingredients in or intended for use in a dietary supplement. 
 
[3] Section 301(ll) also contains other exceptions not relevant here. See 21 U.S.C. 331(ll)(2)-(4).