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WARNING LETTER

Xtra Life Natural Systems, Inc. 04/04/2014

Xtra Life Natural Systems, Inc. - 04/04/2014


Recipient:
Xtra Life Natural Systems, Inc.


United States

Issuing Office:
Florida District Office

United States


  

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

Public Health Service
Food and Drug Administration
 
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
 
Telephone: 407-475-4700
FAX: 407-475-4770 

 

VIA UPS
w/ DELIVERY CONFIRMATION
 
WARNING LETTER
FLA-13-09
April 4, 2014
 
Elena Caro
President
Xtra Life Natural Systems, Inc.
340 Palm Avenue
Hialeah, FL 33010
 
Dear Ms. Caro:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement facility, located at 340 Palm Avenue, Hialeah, FL, from May 30, 2013 through June 5, 2013. During the inspection, you informed our investigator that your firm has entered into agreements with other manufacturers to manufacture dietary supplement products under your firm’s name. The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your 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 the dietary supplement products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
 
FDA reviewed your labels and websites at the Internet addresses www.vtamins.net and www.xtralifemiami.com in January 2014 and has determined that you take orders there for the products Milk Thistle and Gingko Biloba. The labels and websites promote your Milk Thistle and Gingko Biloba products for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your labels and websites establish that the products are drugs 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 may find the Act and FDA’s regulations through links in FDA’s home page at www.fda.gov.
 
Unapproved New Drug Violations
 
Your “Milk Thistle” label and websites, www.vtamins.net and www.xtralifemiami.com, include claims that establish the intended use of your Milk Thistle and Gingko Biloba products as drugs. Examples of some of the claims that provide evidence that your products are intended for use as drugs include:
 
Milk Thistle
  • On the label – “Silybum Marianum … tratamiento de enfermedades tales como hepatitis C y B Cirrhosis Hepatica” which translates to “Silybum Marianum… treatment of diseases such as hepatitis C and B liver cirrhosis.”
  • “[T]herapeutic activity … of Milk Thistle treatment of almost every known form of liver disease, including cirrhosis, hepatitis, hepatitis C, necrosis, and damage due to abuse alcohol and drugs.”
 
Gingko Biloba
  • “[U]sed to treat Alzheimer’s disease and other dementias”
  • “It helps to treat glaucoma”
 
We note similar claims for both products are made in on the Spanish-language version of the www.vtamins.net website and the Spanish-language website www.xtralifemiami.com.
 
Your Milk Thistle and Gingko Biloba 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 section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. 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 Milk Thistle and Gingko Biloba products are 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 layperson can use these drugs safely for their intended purposes. Thus, your Milk Thistle and Gingko Biloba products are misbranded within the meaning of section 502(f)(1) of the Act, in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. 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)].
 
Dietary Supplement CGMP Violations
 
The inspection revealed the following significant violations of the CGMP requirements for dietary supplements. These violations cause your dietary supplement products to be adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions which do not meet the CGMP requirements for dietary supplements. Additionally, even if your Milk Thistle and Gingko Biloba products did not contain disease claims in their labeling that cause the products to be unapproved new drugs under section 505(a) of the Act [21 U.S.C. § 355(a)], they would still be adulterated dietary supplements within the meaning of section 402(g)(1) of the Act because they have been prepared, packed, or held under conditions which do not meet CGMP requirements for dietary supplements.
 
1.    You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103 and 21 CFR 111.140(b)(1). Your quality control personnel must approve for release, or reject, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution, as required by 21 CFR 111.127(h). Specifically, you have not established quality control procedures for conducting a material review and making a disposition decision, and you do not conduct quality control operations to approve for release, or reject, any packaged and labeled dietary supplement for distribution.
 
As a distributor that contracts with other manufacturers to manufacture, package, or label dietary supplements that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how these activities are performed so that you can make decisions related to whether the products conform to established specifications and whether to approve and release the products for distribution. [72 Fed. Reg. 34752, 34790 (June. 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery, of dietary supplements into interstate commerce for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of such products are in compliance with dietary supplement CGMP requirements.
 
Although your firm may contract out certain dietary supplement manufacturing operations, it cannot, by the same token, contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements (see United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act)). In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements (see 21 U.S.C. §§ 342(g) and 331(a)). Thus, a firm that contracts with other firms to conduct certain dietary supplement manufacturing, packaging, and labeling operations for it is responsible for ensuring that the product is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations.
 
You must implement a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.55). You must establish and follow written procedures for the responsibilities of the quality control operations (21 CFR 111.103). The quality control personnel must ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.105). Further, you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement (21 CFR 111.127(h) and 111.140(b)(2)). However, you provided no documentation of the quality control review to ensure the quality of the dietary supplements you distribute and that they are packaged and labeled according to the master manufacturing record.
 
We received your written response dated June 14, 2013, and have determined it to be inadequate. In your response, you state that you are implementing quality control operations and establishing written procedures for your operations. However, your response is inadequate in that you did not provide documentation for FDA to review the adequacy of your proposed corrective actions.  
 
2.    You failed to establish and follow written procedures relating to the review and investigation of product complaints, as required by 21 CFR 111.553.  Specifically, you do not have written procedures for the review of product complaints regarding the dietary supplement products you distribute and for adequately investigating complaints, in accordance with 21 CFR 111.560, and documenting the findings of an investigation and follow-up action taken when an investigation is performed, in accordance with 21 CFR 111.570(b)(2)(ii)(F).
 
3.    You failed to establish and follow written procedures for when a returned dietary supplement is received to fulfill the requirements of 21 CFR Part 111, Subpart N, as required by 21 CFR 111.503. Specifically, you have not established written procedures to be followed when a dietary supplement product is returned and to ensure the proper disposition of returned dietary supplements. Further, once you establish written procedures for when a returned dietary supplement is received to fulfill the requirements of 21 CFR Part 111, Subpart N, you must make and keep records of such written procedures, as required by 21 CFR 111.535(b)(1).
 
4.    You failed to establish a written master manufacturing record (MMR) that identifies specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure that the dietary supplement is packaged and labeled as specified in the MMR, as required by 21 CFR 111.205(b)(1).  Specifically, your firm packages, labels, and distributes your Milk Thistle and Gingko Biloba dietary supplements, but you do not have MMRs for your dietary supplement products that identifies specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure that the dietary supplements are packaged and labeled as specified in the MMR.
 
We received your written response dated June 14, 2013, and have determined it to be inadequate.  In your response, you state that you are in the process of preparing a “master packaging form to record each point, step, or stage in the packaging process where control is necessary to ensure the quality of the dietary supplements [you] manufacture.” You also stated that your “master packaging records” will show “approved packaging instructions, specifications for packaging and labeling, specifications to ensure quality, components with measure, ingredient name with measure, intentional overage, theoretical yield and representative label.”  However, your response is inadequate because you did not provide actual MMRs related to your packaging and labeling operations for FDA to evaluate the adequacy of your proposed corrective actions.
 
5.    You failed to prepare batch production records (BPRs), as required by 21 CFR 111.255, related to your packaging and labeling operations. Specifically, our investigator found that there were no BPRs prepared for the dietary supplement products you package and label in your facility.
 
We received your written response dated June 14, 2013, and have determined it to be inadequate.  Your response indicated that you will prepare a batch production record every time you package a batch of dietary supplements, but you did not provide actual BPRs for your packaging and labeling operations for FDA to evaluate the adequacy of your proposed corrective actions.
 
6.    You failed to establish and follow written procedures for packing and labeling operations, as required by 21 CFR 111.403. Specifically, you do not have written procedures for the packaging and labeling operations for your dietary supplement products. Further, once you establish written procedures for your packaging and labeling operations, you must make and keep records of such written procedures, as required by 21 CFR 111.430(b).
 
7.    You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you do not have written procedures for the holding and distributing operations for your dietary supplement products. Further, once you establish written procedures for your holding and distributing operations, you must make and keep records of such written procedures, as required by 21 CFR 111.475(b)(1).
 
8.    You failed to establish and use appropriate controls to ensure that your automated, mechanical, or electronic equipment functions in accordance with its intended use, as required by 21 CFR 111.30(e).  Specifically, our investigators observed your Pharmafill machine ((b)(4), serial number M2143) packaging your dietary supplement product Prostatil (lot #s 514713- 514716) with an error rate of approximately 20%.  You do not use controls to ensure that your Pharmafill machine functions in accordance with its intended use. You also failed to routinely calibrate, inspect, or check the equipment to ensure proper performance, as required by 21 CFR 111.30(c). Specifically, your Pharmafill equipment was not being used within established operating limits set by the manufacturer’s instructions.
 
We received your written response dated June 14, 2013, and have determined it to be inadequate. In your response, you state that you will establish and use appropriate controls to ensure that your automated, mechanical, or electronic equipment functions in accordance with its intended use. However, your response is inadequate in that you did not provide documentation for FDA to verify the adequacy of your proposed corrective actions.  
 
Dietary Supplement Misbranding Violations
 
1.    Your “Milk Thistle” and “Ginko Biloba” products are misbranded within the meaning of section 403(s)(2)(C) [21 U.S.C. 343(s)(2)(C)] of the Act in that the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).
 
2.    Your “Milk Thistle” and “Ginkgo Biloba” products are misbranded within the meaning of section 403(y) [21 U.S.C. 343(y)] of the Act in that the label fails to include a domestic address or domestic telephone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement.
 
The violations cited in this letter are not intended to be an all-inclusive list of violations at your facility or that exist in connection with your products or their labeling. 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 the Act and applicable 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/or injunction.
 
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 re-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)].  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 non-compliance materially related to a food safety requirement of the Act.  Accordingly, FDA may assess fees to cover any costs related to re-inspection.
 
Please respond to this letter in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you have taken to correct the violations listed above, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. You should include in your response documentation of the corrective actions you have taken. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
 
Please send your reply to the Food and Drug Administration, Attention: Andrea H. Norwood, Compliance officer at 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issues in this letter, please contact Ms. Norwood at (407) 475-4724.
 
Sincerely,
/S/
Elizabeth W. Ormond
Acting Director, Florida District