Glucorell, Inc. / Anafit, Inc. 4/24/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
April 24, 2013
Laurence B. Berube, President
118 Winghurst Blvd.
Orlando, FL 32828-8058
Laurence B. Berube, President
118 Winghurst Blvd.
Orlando, FL 32828-8058
Dear Mr. Berube:
This is to advise you that the U.S. Food and Drug Administration (FDA) inspected your firm Glucorell, Inc. from July 24, 2012 to August 7, 2012 and your firm Anafit, Inc. from July 26, 2012 to August 7, 2012. Both firms are located at 118 Winghurst Blvd., Orlando, Florida. During the inspection, you informed our investigator that your firms hold and distribute dietary supplements for which you have entered into agreements with contract manufacturers to manufacture, package, and label. 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, 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 regulations for dietary supplements.
In addition, FDA reviewed your websites at www.insulow.com and www.theafstore.com in April 2013. Based on our review, we have concluded that your Insulow and Tyler Liver Detoxification Factors 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 establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of the products with these claims 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 website, www.insulow.com, includes claims that establish the intended use of your Insulow product as a drug. Examples of some of the claims include the following:
- “Insulow, recommended in Diabetes Solutions by Dr. R. Bernstein, is pure R+ Lipoic acid complexed with essential Biotin.”
- Read about Insulow in the following books available at Amazon.com.” “Diabietes Solution”, and “Stop Prediabetes Now”. This literature implies that Insulow is intended for use in the cure, mitigation, treatment, or prevention of disease.
- The following journal article can be linked from your website: Effects of R-Alpha Lipoic Acid on HbA1c, Lipids and Blood Pressure in Type-2 Diabetics: A Preliminary Study. Journal of Complementary and Integrative Medicine.
Examples of some of the claims for your Tyler Liver Detoxification Factors product on your firm’s website at www.theafstore.com include the following:
- “Your liver possesses the remarkable capacity to detoxify hundreds of highly toxic chemicals to which your body is constantly exposed. Key nutrients must be present in certain amounts to keep your liver doing its job properly. When the liver is not working properly, there builds up a damaging accumulation of toxins which can lead to chronic degenerative disease.”
- “Detoxification Factors supplies the nutritional precursors & co-factors essential for both Phase I & Phase II liver detoxification pathways.”
Your Insulow and Tyler Liver Detoxification Factors 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)]. Under sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. The introduction into interstate commerce of unapproved new drugs without approved applications violates these provisions of the Act.
Furthermore, your Insulow product is offered for a condition that is 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 this drug safely for its intended purposes. Thus, your Insulow product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling for this drug 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)].
Dietary Supplement CGMP Violations
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). During the inspection, you informed the investigator that you did not have any documentation other than third party certifications that your contract manufacturers follow a written MMR, and you stated that, prior to the time of the inspection, you had never seen a copy of the contract manufacturers’ certificate of analysis. 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 provided no 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 an overarching and ultimate responsibility to ensure that all phases of the production of that product 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)).
2. You failed to establish written procedures for the review and investigation of product complaints, as required by 21 CFR 111.553 and in accordance with 21 CFR 111.560. Specifically, you stated that you have not established written procedures for handling product complaints.
3. You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you receive your products from your contract manufacturers and store them in your residence until you distribute them; however, you have not established and maintained written procedures for your holding and distributing operations.
4. You failed to establish and follow written procedures for handling returned dietary supplements, as required by 21 CFR 111.503. Specifically, you have not established written procedures that specify the procedures to be followed when a dietary supplement is returned by a customer.
The violations cited in this letter 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 ensure 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/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)). 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 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.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you have taken to correct the violations noted 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: Carla A. Norris, Compliance officer at 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issues in this letter, please contact Ms. Norris at (407) 475-4730.
Emma R. Singleton
Director, Florida District