Inspections, Compliance, Enforcement, and Criminal Investigations
Formulife, Inc.Purus Labs, Inc.d.b.a. Dark Cyde Supplements 1/18/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
January 18, 2012
RETURN RECEIPT REQUESTED
Brandon M. Smith, Owner and President
Purus Labs, Inc.
d.b.a. Dark Cyde Supplements
11370 Pagemill Rd.
Dallas, TX 75243
Dear Mr. Smith:
From April 26 through May 19, 2011, the U.S. Food and Drug Administration (FDA) inspected your dietary supplement facility located at 11370 Pagemill Rd., Dallas, Texas. During the inspection, you informed our investigators that your firm has entered into an agreement with a contract manufacturer, (b)(4), to manufacture dietary supplement products that your firm distributes under its own label. You stated that (b)(4) manufactures (b)(4) dietary supplements products that your firm distributes under its own label.
From (b)(4), FDA also inspected (b)(4) dietary supplement manufacturing facility, which is located (b)(4). As an own-label dietary supplement distributor that contracts with another manufacturer to manufacture dietary supplement that your firm releases for distribution under your firm’s name, you are ultimately responsible for complying with the requirements related to manufacturing operations, even though you have hired another person to perform that job task [See 72 Fed. Reg. 34752, 34790 (June 25, 2007)].
During these inspections, our investigators found a number of violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, or Holding Operations for Dietary Supplements regulations, Title 21, Code of Federal Regulations, Part 111, (21 CFR Part 111) for the dietary supplement products that your firm distributes under its own label.
These violations cause your Fat Smack, Halovar InSLINsified, Muscle Marinade (Purus punch flavor and grape juice flavor), Organ Shield, Recycle, and SLINshot dietary supplements to be adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that the dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements.
In addition, we have reviewed the labeling for your Fat Smack, Organ Shield, Recycle, Muscle Marinade (purus punch and grape juice flavors), and SLINshot products, including product labels and your website at www.puruslabs.net. Based on our review, we have concluded that your products are 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). You can find the Act and FDA regulations through links in FDA’s website at www.fda.gov.
1. You have no product specifications for the identity, purity, strength, and composition of your finished dietary supplements, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, your finished dietary supplements to ensure the quality of your dietary supplements [21 CFR 111.70(e)]. Specifically, our investigators observed that no finished product specifications were established for your Purus dietary supplements products, including Fat Smack, Halovar InSLINsified, Muscle Marinade (Purus punch flavor and grape juice flavor), Organ Shield, Recycle, and SLINshot [21 CFR 111.70(e)]. Dietary supplements for which no finished product specifications have been established pursuant to 21 CFR 111.70(e) are adulterated within the meaning of Section 402(g)(1) of the Act.
We note that as a dietary supplement distributor that contracts with a manufacturer to manufacture a dietary supplement that your firm distributes under its own label, you have an obligation to know what and how manufacturing activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution [See 72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)].
2. You did not establish written procedures to fulfill requirements related to returned dietary supplements [21 CFR 111.503]. Specifically, you have not established written procedures that specify the procedures to be followed when a dietary supplement is returned by a customer.
3. You did not establish written procedures to fulfill the requirements related to product complaints [21 CFR 111.553]. Specifically, you have not established written procedures for the review and investigation of product complaints.
Unapproved New Drug Violations
Your website, www.puruslabs.net, promotes your dietary supplement products for conditions that cause the products to be drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)]. The therapeutic claims on your website establish that your products are drugs because they are intended for use in the cure, mitigation, treatment or prevention of disease. Examples of some of the claims found on your website include:
• “[S]tudies found CQ alone . . . caused statistically significant reductions in . . . central obesity . . . [and] cholesterol”
• “[M]ilk thistle [an ingredient in the product] has been used . . . to treat an array of liver ailments.”
• “It [alpha lipoid acid, an ingredient in the product] . . . has blood lipid modulating properties lowering risk factors associated with cardiovascular disease (CVD) . . . .”
• “Saw Palmetto [an ingredient in the product] has been studied for its potential to treat BPH . . . .”
• “It [coenzyme Q-10, an ingredient in the product] . . . has been studied due to the link between people with congestive heart failure and their corresponding low levels of CoQ-10.”
• “Too much DHT is most commonly associated with causing…benign prostate hypertrophy (BPH) and prostate cancer…The second strategic portion [the ingredients bladderwrack, white button mushroom extract, trans-3,4’,5-trihydroxiystilbene, and indole-3-carbinol] of the RecycleTM matrix attacks this head on!”
• “[V]itamin C [an ingredient in the product] has . . . effects on reducing the incidence of the common cold . . . and post-exercise upper respiratory tract infections . . . .”
This product is described on the product label as an “insulin sensitizing/signaling agent used to speed blood glucose clearance . . . .”
• “Optimal management of blood glucose (blood sugar) following feeding is of importance for all individuals. This includes those individuals . . . with elevated fasting blood glucose levels (e.g., pre-diabetics and diabetics) . . . .”
• “In a comparison study conducted using genetically diabetic KK-A(gamma) mice, an alcoholic extract of Artemisia Dracunculus L. var. inodora [an ingredient in the product] was reported to lower elevated blood glucose levels by 24%, while treatment with the antidiabetic drugs Troglitazone and Metformin (Glucophage®) decreased blood glucose concentrations by 28% and 41%, respectively.”
Your products are not generally recognized as safe and effective for the above referenced uses and therefore, the products are “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.
Furthermore, because your products are 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 the products 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)].
Even if your Fat Smack, Organ Shield, Recycle, Muscle Marinade, and SLINshot products did not contain claims on your website that cause them to be unapproved new and misbranded drugs, they would still be misbranded dietary supplements under section 403 of the Act (21 U.S.C. § 343) 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 Fat Smack, Organ Shield, Recycle, and SLINshot 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, as required by 21 CFR 101.4. These products are encapsulated, but the capsule ingredients are not listed in your ingredient statement.
2. Your products Fat Smack, Organ Shield, Recycle, Muscle Marinade, and SLINshot 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 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 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 Fat Smack, Organ Shield, Recycle, Muscle Marinade, and SLINshot product labels do not bear this heading, but instead include the heading “Ingredient” which is not permitted under 21 CFR 101.36.
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 assure that your establishments are 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 subject your firm and products to further actions, such as injunction or seizure.
We also have the following comments:
1. Your firm markets the product REIGN as a dietary supplement; however, this product does not meet the definition of a dietary supplement in section 201(ff) of the Act [21 U.S.C. § 321(ff)]. To be a dietary supplement, a product must, among other things, “bear[ ] or contain[ ] one or more . . dietary ingredients” as defined in Section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)]. Section 201(ff)(1) of the Act 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. The only substances listed as dietary ingredients on the REIGN label are 4-chloro-17a-methyl-androst-1, 4-dien 3-17b-diol and 2a,17a dimethyl-etiocholan-3-one, 17b-ol. These compounds are steroids and are not vitamins, minerals, amino acids, herbs or other botanicals, or dietary substances for use by man to supplement the diet by increasing the total dietary intake. Further, they are not concentrates, metabolites, constituents, extracts or combination of any such dietary ingredients. Therefore, these substances are not dietary ingredients as defined in section 201(ff)(1) of the Act. Thus, because REIGN does not contain a dietary ingredient as defined in section 201(ff)(1) of the Act, this product does not qualify as a dietary supplement.
2. Your Muscle Marinade product label fails to include an asterisk after the values listed for total fat and total carbohydrate and fails to include an asterisk preceding the statement "Percent Daily Values are based on a 2,000 calorie diet” as required by 21 CFR 101.36(b)(2)(iii)(D).
3. The vitamins and minerals that appear on your Fat Smack label do not appear in the correct order; and, the vitamins are not listed by the proper nomenclature (e.g. ascorbic acid in lieu of vitamin C) in accordance with 21 CFR 101.36(b)(2)(i)(B).
4. Your declaration of proprietary ingredients on your Muscle Marinade label 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 (b)(2) of this section. However, your label lists several (b)(2) ingredients such as vitamin C and sodium twice on your Supplement Facts panel.
5. Your Fat Smack 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.
6. The terms “HPTA Upregulation/SHGB Inhibition/Cortisol Suppression (Lutenizing Hormone/Free Testosterone Elicitation),” “Aromatase Inhibition/Estrogen Modulation/DHT Block” and “Absorption Amplification/Glucoronidation Prevention/CYP3A4 Inhibition)” which appear on your Recycle label appear to be fanciful names for your proprietary blends. As such, the label fails to comply with 21 CFR 101.36(c)(3) which requires that the quantitative amount by weight specified for the proprietary blend shall be the total weight of all other dietary ingredients contained in the proprietary blend and shall be placed on the same line to the right of the term "Proprietary Blend" or other appropriately descriptive term or fanciful name underneath the column of amounts described in paragraph (b)(2)(ii) of this section.
7. Your Muscle Marinade 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.”
8. Your Fat Smack and Muscle Marinade product labels fail to declare the quantitative amount by weight per serving of the other dietary ingredient, ginger root in accordance with 21 CFR 101.36(b)(3)(ii). Furthermore, we question whether certain ingredients that are declared on these labels, such as silica, magnesium stearate, or FD&C yellow #5 are other dietary ingredients or ingredients. Other dietary ingredients must be declared in accordance with 21 CFR 101.36(b)(3), while ingredients must be declared in accordance with 21 CFR 101.4(g)
9. Your products fail to list required label statements in an adequate type size as required by 21 CFR 101.3(d), 21 CFR 101.36(i)(2)(ii), 21 CFR 101.105(h) and (i), and 21 CFR 101.2(c) and (f), as follows:
• In accordance with 21 CFR 101.3(d) the statement of identity must be presented in bold type on the principal display panel and shall be in a size that is reasonably related to the most prominent printed matter on such panel. On your Fat Smack, Organ Shield, Recycle, Muscle Marinade, and SLINshot product labels, your statement of identity “dietary supplement” is in a significantly smaller type size and prominence on your labels than are the terms, “fat smackTM”, “organ shieldTM”, “recycleTM”, “muscle marinadeTM”, and “SLINshotTM”.
• Your labels for Fat Smack, Organ Shield, Recycle, Muscle Marinade, and SLINshot products have information in the Supplement Facts Panel in a type size that does not appear to meet the requirements in 21 CFR 101.36(i)(2)(ii).
• Your labels for Fat Smack, Organ Shield, Recycle, Muscle Marinade, and SLINshot products have the net quantity of contents statement in a type size is less than 1/16th inch in height. According to 21 CFR 101.105(h), the net quantity of contents statement on labels with a principal display panel of less than five square inches must have a minimum type size of 1/16th inch in height, and labels with principal display panels of greater than five square inches, but not more than 25 square inches, must have the net quantity of contents statement in a minimum type size of 1/8th inch in height in accordance with 21 CFR 101.105(i).
• Your labels for Fat Smack, Organ Shield, Recycle, Muscle Marinade, and SLINshot products have your name and place of business, “Distributed by PurusLabsTM, 11370 Pagemill Rd., Dallas, TX 75243” in a type size that appears to be less than 1/16th inch in height. According to 21 CFR 101.2(c), all information required to appear on the principal display panel or information panel, including the name and address of the manufacturer, packer, or distributor, must be a minimum of 1/16th inch in height unless an exemption pursuant to 21 CFR 101.2(f) is established. Your type size does not meet the requirement in 21 CFR 101.105(h)(2) that determination of correct type size is done by measuring the height of the letter lower case “o”; your text is 1/16 inch when the upper case letters are measured.
10. Your Muscle Marinade 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.
11. Your SLINshot, Fat Smack, Organ Shield, and Recycle labels state that the products contain botanical ingredients or extracts derived from botanical ingredients but in many instances they do not identify the part of the plant containing in the product or that the extract was prepared from [21 CFR 101.4(h)(1) and 21 U.S.C. 343(s)(2)(C)].
12. The label of Muscle Marinade contains a net serving statement that says "27 True Servings ● Dietary Supplement ● Net Wt. 1.24 lbs. (564 G)". The word "true" and "Dietary Supplement" are intervening material under 21 CFR 101.2(e) and cannot be present in the net contents statement. Moreover, the net content statement as currently presented does not comply with the placement and separateness requirements in 21 CFR 101.105(f).
13. The label for Fat Smack includes the "other ingredient list" inside the nutrition label. This placement does not comply with the placement requirement in 21 CFR 101.4(g).
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.
Your written response should be sent to Seri L. Essary, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Dallas, TX, 75204. If you have questions regarding any issues in this letter, please contact Ms. Essary at (214)253-5335.
Reynaldo R. Rodriguez, Jr.
Dallas District Director