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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

WellnessOne World, LLC 11/16/11

  

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

Public Health Service
Food and Drug Administration
 
Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142 

 

 
November 16, 2011
 
 
WARNING LETTER
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED                                    Refer to MIN 12 - 07
 
 
Timothy Donohue, President
WellnessOne World, LLC
Lifeline Energetics, Inc.
14000 Sunfish Lake Boulevard NW, Suite 100
Ramsey, Minnesota  55303-2934
 
Dear Mr. Donohue:
 
The Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility located at 14000 Sunfish Lake Boulevard NW, Suite 100, Ramsey, Minnesota, on June 7-9, 2011. During the inspection our investigators found a number of serious violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (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 supplements have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements.  
 
In addition, during our inspection we collected samples of labeling for several of your products, and we conducted a review of your website, www.wellnessoneway.com, in November 2011. Our review of your product labeling and promotional claims determined that your ProOneZyme, FlaxOne, OneZyme, OnlyOneGold, and OneBalance products are promoted 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 website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your products with these claims violates the Act. 
 
You may find the Act and the referenced regulations through links on FDA’s home page at http://www.fda.gov.
 
Dietary Supplement CGMP Violations
 
Based on the number of employees, your firm became subject to the dietary supplement CGMP regulations on June 25, 2010. The following are significant violations of these regulations:
  1. Your firm failed to qualify the suppliers of components other than dietary ingredients by establishing the reliability of the suppliers’ certificates of analysis through confirmation of the results of the suppliers’ tests or examinations, before using those components, as required by 21 CFR 111.75(a)(2)(ii)(A), and failed to maintain documentation of how the supplier was qualified, as required by 21 CFR 111.75(a)(2)(ii)(C). Under 21 CFR 111.75(a)(2), a certificate of analysis may be relied upon to confirm the identity of a component that is not a dietary ingredient and to determine whether applicable component specifications established in accordance with 21 CFR 111.70(b) are met. In order to rely on a certificate of analysis from a supplier of the component, the following requirements of 21 CFR 111.75(a)(2)(ii) must be met: (A) qualify the supplier by establishing the reliability of the supplier’s certificate of analysis through confirmation of the results of the supplier’s tests or examinations; (B) the certificate of analysis must include a description of the test or examination method(s) used, limits of the test or examinations, and actual results of the tests or examinations; (C) maintain documentation of how the supplier was qualified; (D) periodically re-confirm the supplier’s certificate of analysis; and (E) the documentation setting forth the basis for qualification (and re-qualification) of any supplier must be reviewed and approved by quality control personnel. Specifically, we reviewed the certificate of analysis for zinc sulfate heptahydrate, lot (b)(4), provided by your supplier. Your firm failed to qualify the supplier by establishing the reliability of the certificate of analysis through confirmation of the results of the supplier’s tests or examinations. 
We have reviewed your response dated June 15, 2011, in which you indicated that you intend to send samples of incoming “raw materials” to an independent laboratory to confirm the results of the supplier’s certificate of analysis before they are used. However, you provided no supporting documentation of your plan to qualify your suppliers. Without this documentation, FDA cannot evaluate the adequacy of your proposed corrective action.
 
  1. Your firm failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity of the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically, our investigators found that you did not prepare MMRs for the following products manufactured at your facility:  BaseLine Minerals, Chromium Mineral Ultra Concentrates (50 ml), Copper Mineral Ultra Concentrates (50 ml), Germanium Mineral Ultra Concentrates (50 ml), Immunitol Minerals, Indium Mineral Ultra Concentrates (50 ml), Iodine Mineral Ultra Concentrates (50 ml), Iron Mineral Ultra Concentrates (50 ml), Lithium Mineral Ultra Concentrates (50 ml), Manganese Mineral Ultra Concentrates (50 ml), Molybdenum Mineral Ultra Concentrates (50 ml), Phosphorus Mineral Ultra Concentrates (50 ml), Rubidium Mineral Ultra Concentrates (50 ml), Sodium Mineral Ultra Concentrates (50 ml), Strontium Mineral Ultra Concentrates (50 ml), Sulfur Mineral Ultra Concentrates (50 ml), and Vanadium Mineral Ultra Concentrates (50 ml).
 
We have reviewed your response dated June 15, 2011, in which you state that you are currently working on finalizing the written MMRs for the above-listed products. However, your response did not provide any supporting documentation for FDA to evaluate the adequacy of your proposed corrective action.
  1. Your firm failed to establish and follow written procedures, as required by 21 CFR 111.553, for the review and investigation of product complaints, as required by 21 CFR 111.560, and the maintenance of records, as required by 21 CFR 111.570.  Specifically, your procedures related to product complaints in your written procedures entitled “Complaint Review Procedures” do not account for all of the requirements of 21 CFR 111.560 and 21 CFR 111.570, as follows:
  • Your procedures do not specify that a qualified person must: (1) review all product complaints to determine whether the product complaint involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of 21 CFR 111; and (2) investigate any product complaint that involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of 21 CFR 111 (21 CFR 111.560(a));
  • Your procedures do not specify that the review and investigation of the product complaint must extend to all relevant batches and records (21 CFR 111.560(c));
  • Your procedures do not specify what records must be made and kept (21 CFR 111.570). Your firm must make and keep a written record of every product complaint related to good manufacturing practice, 21 CFR 111.570(b)(2). The person who performs the requirements of subpart O of Part 111, Product Complaints, must document, at the time of performance, that the requirement was performed, 21 CFR 111.570(b)(2)(i), and the written record of the product complaint must include the following:

o  The name and description of the dietary supplement; the batch, lot, or control number of the dietary supplement, if available; the date the complaint was received and the name, address, or telephone number of the complainant, if available; the nature of the complaint including, if known, how the product was used; the reply to the complainant, if any; and findings of the investigation and follow-up action taken when an investigation is performed, 21 CFR 111.570(b)(2)(ii)(A)-(F).

Unapproved New Drugs
 
Your firm manufactures ProOneZyme, FlaxOne, OneZyme, OnlyOne Gold and OneBalance, which are promoted 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 website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your products with these claims violates the Act. 
Specific examples of claims in your product labeling that promote your products as drugs are as follows (website at www.wellnessoneway.com):
  • “Depression***Recommended products:  OnlyOne Gold, OneBalance, ProOneZyme, FlaxOne.”
  • “ProOneZyme Systemic Enzymes***WellnessOne World ProOneZyme Systemic Enzyme is a blend of 6 diverse plant-based enzymes including Nattokinase which has been shown to dissolve blood clots and reduce the risk of heart disease and Seaprose S which demonstrates an ability to reduce painful inflammation and break up mucus.  Seaprose-S helps alleviate pain, swelling and inflammation.***”
  • “OneZyme Digestive Enzymes***What do they do that is so critical?*** They also function with our immune systems to help dissolve critical parts of the cell walls of enemy (pre-cancer/cancer) cells.  They also positively and dramatically reduce the cycle of symptoms of inflammatory conditions like cardiovascular disease, psoriasis and arthritis***.”
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 ProOneZyme, FlaxOne, OneZyme, OnlyOne Gold, and OneBalance 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 these drugs safely for their intended uses. Thus, these products are misbranded within the meaning of section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1), in that their 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).
 
The above violations are not an all-inclusive list of violations at your facility or in your product labeling. It is your responsibility to ensure that all your products and labeling are in compliance with the Act and its implementing regulations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction. 
 
Please respond in writing within 15 working days from your receipt of this letter with the specific steps you have taken to correct the violations noted above and to prevent similar violations. Your response should include any documentation necessary, such as revised labels or other useful information to show that correction has been achieved. If you cannot complete all corrections before you respond, please state the reason for the delay and the date by which the corrections will be completed.
 
Please send your reply to the attention of Demetria L. Lueneburg, Compliance Officer, at the address on the letterhead. If you have any questions regarding any issue in this letter, please contact Ms. Lueneburg at (612) 758-7210.  
 
Sincerely,
/S/                                                                                                         
Elizabeth A. Waltrip
Acting Director
Minneapolis District