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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
April 1, 2014
Via UPS Overnight Delivery
Refer to MIN 14 – 14
Mark K. Mathews
3255 Hennepin Avenue South
Minneapolis, Minnesota 55408
Dear Mr. Mathews:
On May 15-17, 2013, the United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 3255 Hennepin Avenue South, Minneapolis, Minnesota. This inspection found that your firm distributes dietary supplements under your firm’s name, and that you provide labels to the other firms that manufacture your dietary supplement products on your behalf.
During the inspection the investigator identified significant violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your dietary supplements 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. The investigator’s observations were noted on form FDA-483, Inspectional Observations, which was issued to you on May 17, 2013.
Additionally, we reviewed your website at the Internet address http://www.bio-recoveryinc.com and have determined that you take orders there for the Bio-Lithium, Niacinamide, Bio-Aminos, and CoQ-10products, which the website promotes 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 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 can find the Act and related regulations through links on FDA’s internet home page at www.fda.gov
Unapproved New Drugs
Specific examples of some of the website claims that provide evidence that your products are intended for use as drugs are below. Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of products for the cure, mitigation, treatment, or prevention of disease. Examples of claims include:
- “…[w]e’ve seen many positive benefits…particularly for alcoholics.”
- “Lithium [an ingredient] reduces the number of days incapacitated by drinking severe enough to need detoxification.”
- “Other areas Lithium treatment shows promise for include: …Cluster Headaches; Hyperthyroidism/Graves Disease; Gout; Fibromyalgia; Herpes Simplex and other Viruses.”
- “Excerpt from…Dr. Hans Nieper…‘Lithium has proven very useful in the treatment of diseases.…in the defense against cancerous diseases. … In addition, I have found lithium orotate particularly beneficial in the treatment of migraine and frequently recurring headaches.’”
- “…B3 treatment has been used successfully to treat some forms of schizophrenia....”
- “Niacin is also important in treating…allergies….”
- “Niacin has been used to treat and correct: Learning disorders[;] …Insomnia[;] …Neurosis[;] …Addictions[;] Alcoholism[;] Headaches[;] …Convulsions….”
- “…Niacin has been shown effective in: Lowering of high cholesterol…[;] The therapeutic treating of schizophrenia…[;] Learning and behavior disorders among children[;] Drug addiction (B3 is a good antidote against LSD intoxication)[;] Alcoholism[;] …The treatment of physical maladies: Helps to…[;] Useful in the treatment and prevention of arthritis[;] Useful in the prevention of juvenile diabetes.”
- “Amino acids [ingredients in your product]…Promote wound healing…[;]Reduce blood pressure[;] Lowering cholesterol…[;] Relieve pain[;] Provide relief for ailing gall bladders[;] Fight drug addiction[;] Control Parkinson’s disease[;] Prevent insomnia....”
- “L-Cysteine: Helps repair tissues damaged by alcohol abuse, cigarette smoke, and air pollution…[;] Promotes…tissue restoration in lung diseases[;] Protects lungs against cigarette smoke damage[;] Used to treat bronchial disease and asthma.”
- “L-Histidine…Shows promise as an answer for rheumatoid arthritis….”
- “L-Glycine…Decreases uric acid levels to reverse gout[;] Has been shown useful in epilepsy....”
- “L-Proline: Can help lower blood pressure[;] Promotes wound healing.”
- “L-Taurine: Can help inhibit epileptic seizures[;] Helps repair muscle and tendon damage…[S]tops alcohol withdrawal tremors….”
- “L-Glutamine…Is useful in treating alcoholism and hypoglycemia.…”
- “L-Phenylalanine…Increases blood pressure in individuals with low blood pressure.”
- “L-Lysine…Helps those recovering from surgery and injuries[;] Controls…spastic disorders[;] …Controls viral infections[;] Inhibits growth and recurrence of herpes complex.”
- “L-Arginine…[T]reats sterility in men[;] …[H]elpful in cirrhosis of the liver[;] …Retards the growth of tumors and cancer.”
- “L-Alanine…Helpful for hypoglycemics[;] …May be helpful in preventing seizures[;] Combined with high doses of B6, plays an important role in reversing immune deficiency.…”
- “Has been used for patients with heart disorders, including Cardiomyopathy, Myocardial Ischemia, Angina, Hypertension and congestive heart failure. ... Deficiencies have been reported in patients with cardiac disorders, cancer, diabetes, periodontal disease, muscular dystrophy, hypertension and AIDS.”
- “Low levels of Co-Q 10 may be a contributing factor in illnesses associated with age-related illnesses such as heart disease, cancer and Alzheimer’s.”
- “Co-Q 10 supplementation…improves a variety of heart conditions such as cardiomyopathy, congestive heart failure, valve problems, unstable angina and high blood pressure.”
- “C-0[sic] 10...anticarcinogenic properties, and studies indicate beneficial results with Co-Q 10 supplementation in breast cancer patients.”
- “…[O]ral administration of Co-Q 10 to patients with periodontal disease showed improvement in suppressing gingival inflammation….”
- “…[L]ow levels of Co-Q 10 in diabetics, and supplementation may enhance…may improve insulin sensitivity. Supplementation could lower the incidence of cardiovascular problems, which are common in diabetics.”
- “Supplementation...may even slow down or possibly reverse some age related brain disorders, such as Alzheimer’s, Huntington’s and Parkinson’s.”
The products identified above 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). 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, these products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, the labeling of Bio-Lithium, Niacinamide, Bio-Aminos, and CoQ-10 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
Even if the products discussed above did not have therapeutic claims which make them unapproved, new and misbranded drugs, your dietary supplement products are adulterated based on the following significant violations:
1. You failed to identify personnel to be responsible for your quality control operations, as required by 21 CFR 111.12(b). Furthermore, 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).
During the inspection you stated to our investigator that your dietary supplement product formulations, testing, and manufacturing operations are the responsibility of your manufacturing contractors; however, your firm’s 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). You did not provide written procedures for the approval for release of your dietary supplements by the quality control personnel.
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 manufacturing, packaging, and labeling operations 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 [72 Fed. Reg. 34752, 34790 (June. 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery, of the dietary supplement into interstate commerce in its final form for distribution to consumers. As such, your firm has the ultimate responsibility to ensure that all phases of production of that product are in compliance with dietary supplement CGMP requirements.
Although your firm may contract out certain dietary supplement manufacturing operations, your firm 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) of the Act 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 is responsible for ensuring that the product is not adulterated by 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 supplements and that the dietary supplements are packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.55. You must establish and follow written procedures for the responsibilities of the quality control operations, as required by 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, as required by 21 CFR 111.105. Furthermore, you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement, as required by 21 CFR 111.127(h) and 111.140(b)(2). However, you did not provide 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.
2. You failed to collect and hold reserve samples of packaged and labeled dietary supplement products that you distributed, as required by 21 CFR 111.83(a). Specifically, you had no reserve samples of dietary supplement products that you distribute.
3. You failed to establish and follow written procedures for packaging and labeling operations, as required by 21 CFR 111.403. Specifically, you do not have written procedures for your labeling operations. You must control the issuance and use of labels, as required by 21 CFR 111.410(b), and you must suitably dispose of labels for dietary supplements that are obsolete or incorrect to ensure that they are not used in any future label operations, as required by 21 CFR 111.415(h).
4. 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 your holding and distribution operations.
5. You failed to establish and follow written procedures for returned dietary supplements, as required by 21 CFR 111.503. Specifically, you do not have written procedures for returned dietary supplements.
6. You failed to establish and follow written procedures for product complaints, as required by 21 CFR 111.553. Specifically, you do not have written procedures for product complaints.
When discussing the above requirements with our investigator during the investigation, you informed the investigator that you were not aware of the dietary supplement regulations and that no records were available.
The above violations are not intended to be an all-inclusive list 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 assure that your firm complies with all requirements of federal law and FDA regulations. Failure to take prompt action to correct the above violations may result in regulatory action without further notice, such as 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 costs related to re-inspection. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-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 re-inspection-related costs.
Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct and prevent the recurrence of violations, and provide copies of supporting documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the date by which you will have completed the corrections.
Your response should be directed to Melissa I. Michurski, Compliance Officer, at the address listed above. You can contact Ms. Michurski at (612) 758-7185 with any questions regarding this letter.
Michael Dutcher, DVM