Inspections, Compliance, Enforcement, and Criminal Investigations

A2Z Industries, LLC 2/9/15

  

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

Public Health Service
Food and Drug Administration
 Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
FAX: 949-608-4415 

 

WARNING LETTER

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

February 9, 2015
 

WL# 08-15

Jesse C. Randle, Owner
A2Z Industries, LLC
14444 Magnolia Boulevard, # 199
Sherman Oaks, CA 91423
 

Dear Mr. Randle:

The U.S. Food and Drug Administration (FDA or we) inspected your firm, A2Z Industries, LLC, located at 4138 Sepulveda Blvd., Sherman Oaks, California, from April 17, 2014, to April 22, 2014. During the inspection, our investigator collected labeling for several of your products. Additionally, FDA reviewed your website at http://vitallabsusa.com in March 2014. The claims on your product labels and website establish that your Halo V, EPI 2A3A, and Protex products are drugs under section 201(g)(1)(B) and (g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B) and (g)(1)(C)]. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. Additionally, based on our review of your product labeling, we have concluded that your Post Cycle 3X and Blockade on Cycle Defense products are misbranded dietary supplements under section 403 of the Act (21 U.S.C. § 343).

Misbranded and Unapproved New Drugs

Your product labels and website at http://vitallabsusa.com, from which website you provide links to retailers that offer your products for sale, include the following claims about the effects of your products:

HaloV
• "Rapid Muscle Growth" (product label)
• "Muscle Hardening" (product label)
• "[L]ean muscle mass gains ... " (website) 

EPI2A3A
• "[P]ack on lean muscle mass ... " (website) 

Protex
• "Protex contains a unique combination of specifically dosed ingredients used in Chinese and European natural medicines to improve ... blood pressure, cholesterol ... " (product label) 

These products are represented as dietary supplements on their labels; however, the substances listed as dietary ingredients on your labels of EPI 2A3A and Halo-V are synthetic steroids-2a, 3a-epithio- 17a-methyletioallocholanol and 4-chloro-17a-methyl-androst-1, 4-diene-3, 17b-diol, respectively which are not dietary ingredients as defined in section 201(ff)(1) of the Act (21 U.S.C. § 321(ff)(1)). Under section 201(ff)(1) of the Act, a dietary ingredient is 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 such ingredient. Because your Halo V and EPI 2A3A products do not include a dietary ingredient, these products are not dietary supplements as defined in section 201(ff) of the Act (21 U.S.C. § 321(ff)). Rather, under section 201(g)(1)(C) of the Act (21 U.S.C. § 321(g)(1)(C)), your EPI 2A3A and Halo-V products are drugs because they are articles (other than food) intended to affect the structure or function of the human body. Additionally, under section 201(g)(1)(B) of the Act (21 U.S.C. § 321(g)(1)(B)), your Protex product is a drug because it is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

Your EPI 2A3A, Halo-V, and Protex 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)). Under sections 301(d) and 505(a) of the Act (21 U.S.C. §§ 331(d) and 355(a)), new drugs may not be introduced or delivered for introduction into interstate commerce unless an FDA approved new drug application (NDA) is in effect for them. The sale of new drugs without approved NDAs violates these provisions of the Act. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

According to section 502(f)(1) of the Act (21 U.S.C. § 352(f)1l)), a drug is misbranded if it fails to bear adequate directions for use. "Adequate directions for use" means directions under which a layman can use a drug safely and for the purposes for which it is intended (21 CFR § 201.5). Prescription drugs, as defined under section 503(b)(1)(A) of the Act (21 U.S.C. § 353(b)(1)(A)), can only be used safely at the direction, and under the supervision, of a licensed practitioner. Your EPI 2A3A and Halo-V products are "prescription drugs" because their toxicity or other potential harmful effects, or their method of use, or the collateral measures necessary to their use renders use of the products unsafe except under the supervision of a licensed practitioner. Indeed, all anabolic steroid drugs which have been approved for marketing by the FDA are limited by an approved new drug application to use under the professional supervision of a practitioner licensed by law to administer such a drug. Your Protex product is also a "prescription drug" because of the potential harmful effects of using your product without adequate directions. Given the potential harmful effects of using these products, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your EPI 2A3A, Halo-V, and Protex products fail to bear adequate directions for their intended use and, therefore, are misbranded under section 502(f)(1) of the Act (21 U.S.C. § 352(f)(1)). The introduction or delivery for introduction, or causing the introduction or delivery for introduction, into interstate commerce of these misbranded products violate section 301(a) of the Act (21 U.S.C. § 331(a)). 

Misbranded Dietary Supplements

Your Blockade dietary supplement product is misbranded within the meaning of section 403(y) of the Act, 21 U.S.C. § 343(y), in that the label fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761(b)) may receive a report of a serious adverse event with such dietary supplement.

Your Post Cycle 3X and Blockade on Cycle Defense dietary supplement products are misbranded within the meaning of section 403(s)(2)(C) of the Act, 21 U.S.C. § 343(s)(2)(C), in that the labels fail to identify the part of the plant (e.g., seed, leaves) from which the ingredient is derived. Additionally, even if your Protex were not a drug, it would be misbranded within the meaning of section 403(s)(2)(C) of the Act. For example, your product labels declares the presence of milk thistle but you do not declare the part of the plant from which it is derived from in accordance with 21 CFR 101.4(h)(1).

Your Blockade on Cycle Defense product is misbranded within the meaning of section 403(q)(5)(F) of the Act, 21 U.S.C. 343(q)(5)(F), in that the nutrition information on the product label does not comply with 21 CFR 101.36(b)(2)(i)(B). Additionally, even if your Protex were not a drug, it would be misbranded within the meaning of section 403(q)(5)(F) of the Act. For example, your selenium and Vitamin B6 dietary ingredients are not listed in the correct order within your "Supplement Facts" panels, respectively, as required by 21 CFR 101.36(b)(2)(i)(B).

Your Post Cycle 3 X dietary supplement product is misbranded within the meaning of section 403(q)(1)(A) of the Act, 21 U.S.C. 343(q)(1)(A), because the label fails to declare the correct serving size, as required by 21 CFR 101.36(b)(1). The serving size for dietary supplements must be determined in accordance with 21 CFR 101.9(b) and 101.12(b), Table 2. Under 21 CFR 101.9(b)(2), the serving size must be determined from the "Reference Amounts Customarily Consumed Per Eating Occasion" (RACC) that appear in 101.12(b). The RACC for dietary supplements is the maximum amount recommended, as appropriate, on the label for consumption per eating occasion. The labeling Post Cycle 3 X recommends taking 2 capsules twice per day. Therefore, the serving size must be based on a RACC of 2 capsules for it. However, the label for Post Cycle 3 X incorrectly declares the serving size as 4 capsules.

Your Blockade on Cycle Defense and Post Cycle 3 X dietary supplement products are misbranded within the meaning of section 403(e)(1) of the Act, 21 U.S.C. 343(e)(1), because the name and/or place of business are not listed on the labels as required by of 21 CFR 101.5. Additionally, even if your Protex were not a drug, it would be misbranded within the meaning of section 403(e)(1) of the Act.

Your Blockade on Cycle Defense dietary supplement is misbranded within the meaning of section 403(e)(2) of the Act, 21 U.S.C. 343(e)(2), because the net quantity of contents in terms of weight, measure, or numerical count is not listed on the principal display panel of the label as required by 21 CFR 101.105(a).

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injection. Other federal agencies may take this Warning Letter into account when considering the award of contracts.

Within fifteen working days of the receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Furthermore, please advise this office what actions you will take to address product that you have already distributed. Additionally, if another firm manufactures the products identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the products is not the manufacturer, please include the name of your supplier in addition to the manufacturer.

Address your reply to CAPT Daniel Cline, Acting Director, Compliance Branch, U.S. Food and Drug Administration, 19701 Fairchild, Irvine, CA. If you have any questions or concerns, please contact Dr. Raymond W. Brullo, Compliance Officer at (949) 608-2918.
 

Sincerely,
/S/
Alonza E. Cruse, District Director
Los Angeles District
 
Cc:

A2Z Industries LLC
4341 Teesdale Ave.
Studio City, CA 91604
 

Harlan Loui, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 997435
Sacramento, CA 95899-7435
Attn: FDA Correspondence

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