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WARNING LETTER

JW Nutritional LLC Dallas MARCS-CMS 437535 —


Recipient:
JW Nutritional LLC Dallas


United States

Issuing Office:
Dallas District Office

United States


  

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 

 

March 25, 2015
 
2015-DAL-WL-15
 
 
WARNING LETTER
 
UPS OVERNIGHT
 
Jesse D. Windrix, President
JW Nutritional LLC
601 Century Parkway, Suite 300
Allen, Texas 75013
 
Dear Mr. Windrix:
 
The U.S. Food and Drug Administration (FDA or we) inspected your facility located at 601 Century Parkway, Suite 300, Allen, Texas, from May 20 through June 6, 2014. Our inspection revealed a number of violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your Vanish V2 Domestic, Mr. Hyde Fruit Punch, and Garcinia Cambogia dietary supplement products 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 these products have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements. These inspectional observations were provided to you on the Form FDA-483 issued at the conclusion of our inspection on June 6, 2014.
 
In addition, we have reviewed your website at www.transformsupplements.net in March 2015 and have determined that you provide a link to websites from which your Forged Joint Repair, Forged Liver Support, and Forged Methyl EAA products may be purchased. The claims on your website establish that these products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links at FDA’s home page at http://www.fda.gov. 
 
Unapproved New Drugs and Misbranded Drugs
 
Examples of some of the website claims that provide evidence that your Forged Methyl EAA, Forged Joint Repair and Forged Liver Support products are intended for use as drugs include:
 
Forge Methyl EAA:
·    “Icaritin [an ingredient in the product] has also been shown in studies to have neuroprotective effects by acting as an anti-inflammatory”
·    “[S]arcosine [an ingredient in the product]...has been shown in studies to improve the symptoms of neurologic diseases such as schizophrenia and depression”
 
Forged Joint Repair:
·    “Forged Joint Repair is enhanced with herbs and extracts that …heal bones…and provide…anti-inflammatory support”
·    “Glucosamine and Chondroitin [ingredients in the product] are both commonly found in joint formulas due to years of research proving their ability to slow osteoarthritis.”
·    The product name, “Joint Repair,” implies the product is for use in the cure, mitigation, or treatment of a diseased or damaged state.
 
Forged Liver Support:
·    “Reduces Inflammation”
 
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 introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. § 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. 
 
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 C.F.R. § 201.5). Prescription drugs, as defined in 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 Forged Joint Repair and Forge Methyl EAA products are intended for prevention or treatment of one or more diseases that are not amenable to self-diagnosis or treatment. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your Forged Joint Repair and Forge Methyl EAA products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
 
Adulterated Dietary Supplements
 
Your Vanish V2 Domestic, Mr. Hyde Fruit Punch, and Garcinia Cambogia are adulterated dietary supplements within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements. The following violations were observed during the inspection:
 

1.    You failed to prepare and follow a master manufacturing record (MMR) for the manufacture of your Mr. Hyde Fruit Punch, Vanish V2 Domestic, and Garcinia Cambogia products that (1) identifies specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR; and (2) establish controls and procedures to ensure that each batch of dietary supplement that you manufacture meets the specifications you have identified, as required by 21 CFR 111.205(b).  Specifically, your MMRs failed to include the following:

 
·    A complete list of components to be used, as required by 21 CFR 111.210(b);
·    An accurate statement of the weight or measure of each component to be used, as required by 21 CFR 111.210(c);
·    The identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label and the identity of each ingredient that will be declared on the ingredients list of the dietary supplement, as required by 21 CFR 111.210(d);
·     A description of packaging and a representative label, or a cross-reference to the physical label location of the actual or representative label, as required by 21 CFR 111.210(g); and
·    Written instructions detailing specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR, as required by 21 CFR 111.210(h)(3).
 
Additionally, your MMRs list steps that are inappropriate for the specific products you manufacture, such as steps for tableting of Garcinia Cambogia and Vanish V2 Domestic, which are encapsulated products, and steps for encapsulation of Mr. Hyde Fruit Punch, which is packaged in powder form.
 
We have received and evaluated your response letter dated June 26, 2014. Your response letter states that your new MMRs include instructions for mixing ingredients so that the employees will know exactly which ingredients are excipients, and the order of addition of each ingredient. However, the revised MMR provided with your response does not contain mixing instructions such as the sequence of addition of components, mixer to be used, mixing time, and any other factors that may be necessary to ensure uniformity within the batch and from batch to batch.
 

2.    Your batch production records (BPRs) failed to include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and 21 CFR 111.260. Specifically, the BPRs for your Garcinia Cambogia (lot 102820414) and Vanish V2 Domestic (lots 102430114 and 109490314) products failed to include the following:

 
·    Documentation, at the time of performance, of packaging and labeling operations including the unique identifier that you assigned to packaging and labels used, an actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the MMR, as required by 21 CFR 111.260(k); and
·    Documentation at the time of performance that quality control personnel approved and released, or rejected, a batch for distribution, as required by 21 CFR 111.260(l)(3).
 
Specifically, the batch record for your Garcinia Cambogia lot 102820414 contained a label that was not identical to the label used during production of the batch. Further, the batch records for Vanish V2 Domestic lots 102430114 and 109490314 failed to include actual or representative labels. Additionally, your batch records for Garcinia Cambogia (Batch production record 102820414) and Vanish V2 Domestic (Batch product record 102430114 and 109490314) did not contain documentation at the time of performance that quality control personnel approved and released, or rejected, the batch for distribution.
 
We have received and evaluated your response letter dated June 26, 2014. Your response letter states that although the batch record for Garcinia Cambogia did not contain the label used in the production of the batch, it did contain a label that listed the same supplement facts information and ingredients and differed only in design elements. However, the label included with your response did not reflect the ingredients in the MMR. Such a label does not constitute an actual or representative label, and its use in the BPR does not satisfy the requirements of the rule.
 
Your response letter also states that the batch records for Vanish V2 Domestic did not contain labels because your firm did not label this product. This assertion, however, is inconsistent with the Label Reconciliation section of the batch records for your Vanish V2 Domestic lots 102430114 and 109490314, which lists “total quality of used labels” for these batches as (b)(4) and (b)(4), respectively.
 
Your response also states that at the time of the inspection, you were using Certificates of Analysis to demonstrate the release of product for distribution, and that going forward you will file the Certificate of Analysis with your BPRs. However, we are unable to evaluate this correction because supporting documentation (i.e., certificate of analysis used at product release) was not provided.
 
Lastly, your response does not provide evidence of an executed BPR to show corrective actions implemented to ensure a representative label or cross reference to its location is included as part of the batch production record.
 
3.    You failed to establish specifications for dietary supplement labels (labeling specifications) and for packaging that may come in contact with dietary supplements, as required by 21 CFR 111.70(d). Specifically, you have not established label specifications for any of the dietary supplements that you manufacture.
 
We have received and evaluated your response letter dated June 26, 2014. Your response states that you are creating a Master Label Specification for each label and that you will use an actual physical label as your label specification. You also provided a copy of the Label Specification for Garcinia Cambogia Super Citrimax as an example. However, you have not provided evidence of Label Specifications for any of the other products you manufacture and distribute.
 

4.    Your quality control operations failed to include determining whether the finished packaged and labeled dietary supplement conforms to specifications established for the packaging and labeling of the finished dietary supplements, including specifications that ensure that you used the specified packaging and that you applied the specified label, as required by 21 CFR 111.127(d). Your quality control operations also failed to include approving for release, or rejecting, any packaged and labeled dietary supplement for distribution, as required by 21 CFR 111.127(h). 

 
During the inspection it was revealed that Garcinia Cambogia lot 102820414 and Vanish V2 Domestic lot 109490314 had been released for distribution prior to packaging and labeling of the products.
 
We have received and evaluated your response dated June 26, 2014. Your response states that you will collect finished products for testing after the packaging and labeling process is performed, and if packaging and labeling of a lot occurs on more than one occasion, each portion will have a separate lot code and release. However, you have provided no documentation regarding the implementation of this new process.
 
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 injunction.
 
Additionally, we have the following comment. Please also be advised that 21 CFR 111.70(b) requires manufacturers to establish component specifications, including those for capsules used for encapsulated products. 
 
On June 26, 2014, you provided copies of specifications for the capsules you use. According to the specifications, you use data from the capsule manufacturer’s certificates of analysis for determining compliance with some aspects of the specifications, including for limits on heavy metal and microbiological contaminants. However, the specifications you provided do not document that you have qualified the suppliers by establishing the reliability of the supplier’s certificate of analysis (see 21 CFR 111.75(a)(2)(ii)(A) through (E)).
 
Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
 
Within fifteen working days of 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.
 
Please send your reply to the Food and Drug Administration, Attention: John W. Diehl, Compliance Officer, at the above letterhead address. If you have questions regarding any issues in this letter, please contact Mr. Diehlat (214) 253-5288.
 
Sincerely,
/S/ 
Reynaldo R. Rodriguez, Jr.
Dallas District Director
 
 
CC:
 
Greg Wilburn
Inspection Unit Manager
Food and Drugs Inspection Branch
Texas DSHS
1100 West 49th Street
Austin, Texas 78756

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