Jacob Geissler, CEO and Co-Owner
10761 King William Drive
Dallas, Texas 75220
Dear Mr. Geissler:
From February 7 through 21, 2012, the U.S. Food and Drug Administration (FDA) inspected your facility located at the above-referenced address. During the inspection, our investigators evaluated the manufacturing of several of your products, which you label as dietary supplements, including Jack3d, OxyElite Pro, and Super Cissus.1
In addition to the inspection, our investigators reviewed the labeling for your products found on your website http://www.usplabsdirect.com in October 2012. Based on our review, we found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and the referenced regulations through links on FDA's homepage at www.fda.gov.
Unapproved New Drug Violations
Based on our review of the labeling of your product, Super Cissus, from your website at www.usplabsdirect.com, and information your firm provided during the inspection, we have concluded that this product is promoted for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Act [21 U.S.C. § 321 (g)(1)(B)]. The claims on your labeling establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your product with these claims violates the Act.
Your labeling contains disease claims including:
• "Cissus quadrangularis, has been found to reduce LDL .... In an eight-week randomized, double blind, placebo-controlled study ... obese subjects taking Cissus experienced reductions in ... LDL .... "
Your product Super Cissus is not generally recognized as safe and effective for the above referenced uses and, therefore, it is also a new drug under section 201 (p) of the Act [21 U.S.C. § 321 (p)]. A new drug may not be legally marketed in the United States 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, your product is offered for conditions that are not amenable to self diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use cannot be written so that a layman can use this drug safely for their intended uses. Thus, this product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that its labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331 (a)].
Adulterated Dietary Supplements
In addition, even if your product listed above was not an unapproved new and misbranded drug, it and the other products distributed under your firm's label would be adulterated dietary supplements within the meaning of section 402(g)(1) of 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 the requirements set forth in the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, or Holding Operations for Dietary Supplements regulation, Title 21, Code of Federal Regulations, Part 111, (21 CFR Part 111).
Based on the records reviewed during this inspection, your firm sends raw materials to contract manufacturers who manufacture (b)(4) dietary supplements including Jack3d, OxyElite Pro, Prime, and Super Cissus various packaging configurations and flavors, and then return the finished products to USPlabs for distribution under your firm's own label. As a dietary supplement distributor that contracts with another contract manufacturer to manufacture dietary supplement under your firm's name, your firm is ultimately responsible for complying with the requirements relating to manufacturing operations [see 72 Fed. Reg. 34752, 34790; June 25, 2007]. Your firm has 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.
Furthermore, we received your firm's written responses with attachments from Lorena Macias, Quality Assurance and Quality Control Director, dated March 14 and June 1, 2012, to the Form FDA 483 (inspectional observations) that was issued to your firm at the conclusion of the inspection on February 21, 2012. We respond to your firm's written responses, below.