TruVision Health LLC 11/30/17

Transcription

1 TruVision Health LLC 11/30/17 Denver District Office 6 th Ave & Kipling St, Bldg 20 DFC P.O. Box Denver, CO November 30, 2017 WARNING LETTER Via UPS Overnight Ref: # HAFW4(DEN) WL David A. Brown, Owner TruVision Health, LLC South Business Park Drive Suite 114 Draper, UT Dear Mr. Brown: On May 15, 22-25, 30-31, 2017, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at South Business Park Drive, Suite 114, Draper, Utah. The inspection revealed serious violations of FDA s Current Good Manufacturing Practice (CGMP) in 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 products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Further, a review of the product labels collected during the inspection, and a review of your website at identified serious violations of the Act and applicable regulations. You can find copies of the Act and pertinent regulations through links on FDA s homepage at ( Unapproved New Drugs and Misbranded Drugs

2 FDA reviewed your website at the internet address in November 2017 and has determined that you take orders there for the products truweight & Energy Gen 2, Ubiquinol, Omega 3, Pycnogenol, renu, and truelevate. The claims on your website establish that the 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. Examples of some of the claims that provide evidence that your products are intended for use as drugs include the following: truweight & Energy Gen 2 B-12 [an ingredient in the product]: known to lessen muscle pain... and combat mild levels of depression... Benzylamine HCL [an ingredient in the product]:... It is used to help regulate blood sugar thus inhibiting blood sugar spikes which in turn helps minimize insulin spikes. Niacinamide [an ingredient in the product]:... used to combat high cholesterol... reduce migraine headaches... help control blood sugar... used by individuals to address ADHD, Alzheimer s, deression (sic). Methylcobalamin [an ingredient in the product]:.. is also known to... lessen muscle pain... and combat mild levels of depression. Ubiquinol [U]biquinol actually keeps your LDL (often referred to as the bad cholesterol) reduced Omega 3 It is interesting to note that omega-3 fatty acids help reduce inflammation renu Gentle relief from irregularity and constipation truelevate Huperzine (A) [an ingredient in the product]: Currently being researched for its potential benefits to individuals with Alzheimer s disease Pycnogenol PYCNOGENOL is one of nature s most powerful anti-oxidants. Anti-oxidants neutralize freeradicals in the body. Free radical damage has been linked to almost every debilitating and degenerative disease and condition known to man. These include: Alzheimer s, cancer, M.S., dementia, coronary failure, stroke, and pulmonary disease to name a very view. Free radical damage has also been linked to prostrate (sic) dysfunction, menstrual complications, arthritic conditions, immune system dysfunction and more. 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)(1) of the Act [21 U.S.C. 321(p) (1)]. New drugs may not be legally marketed in the United States without prior approval from FDA,

3 as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d) and 355(a)]. FDA approves a new drug based on scientific data submitted by a drug sponsor to demonstrate 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 CFR 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 products truweight & Energy Gen 2, Pycnogenol, and truelevate are intended for prevention or treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use these products safely for their intended purposes. Accordingly, truweight & Energy Gen 2, Pycnogenol, and truelevate 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 dietary supplement products are adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] because the products have been held under conditions that do not meet the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (CGMP) regulation, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Additionally, even if your truweight & Energy Gen 2, Ubiquinol, Omega 3, renu, and truelevate products did not have therapeutic claims which make them unapproved new drugs and/or misbranded drugs, these products would be adulterated dietary supplements within the meaning of section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] because the products have been held under conditions that do not meet the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (CGMP) regulation, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Specifically, your quality control unit failed to approve for release, or reject, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement), as required by 21 CFR (h). You also failed to make and keep written documentation, at the time of performance, that quality control personnel performed the required quality control review, as required by 21 CFR (b)(2). At the time of the inspection, you had no quality control procedures in place, and this deficiency was noted in the Form FDA 483 issued to you at the close of the inspection. In your response dated July 14, 2017, you provided copies of your new Standard Operating Procedures (SOPs) for quality control. While your new SOPs provide, some information pertaining to the quality control procedures we understand that you intend to implement, the information provided with your response fails to demonstrate that you are conducting the required quality control procedures for approving for release, or rejecting, your packaged and labeled dietary supplement for distribution. The adequacy of your corrective actions will be evaluated during the next inspection.

4 As a distributor that contracts with a manufacturer to manufacture, package, and label dietary supplements on your behalf that your firm releases for distribution under your firm s name, your firm has an obligation to know what and how manufacturing, packaging, and/or labeling activities 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 , (Jun. 25, 2007)]. Although a firm may contract out certain dietary supplement manufacturing, packaging, and/or labeling operations, it cannot 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. 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 out some or all its operations must establish 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 ). The quality control personnel must also ensure that the 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 )., 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) We also note that in your response letter dated July 14, 2017, you provided finished product specifications for truweight & Energy GEN2 and trufix dietary supplements. Conducting quality control to ensure that these specifications are met is insufficient to ensure the quality of the dietary supplement. Specifically, identity of a dietary supplement refers to the dietary supplement s consistency with the master manufacturing record and/or that it is the same as described in the master manufacturing record [see 72 FR at 34803]. Your identity specification for physical property describes the appearance and physical attributes of the dietary supplement; however, these attributes alone do not adequately ensure the dietary supplements consistency with the master manufacturing record to ensure the quality of the dietary supplement. Therefore, such specifications would not provide an appropriate basis upon which your quality control personnel could rely on for approval for release of any packaged and labeled dietary supplement for distribution [21 CFR (h)]. Misbranded Dietary Supplements Based on labeling collected during the inspection of your firm, we note that several of your products are misbranded under section 403 of the Act and FDA s labeling regulations, Title 21, Code of Federal Regulations, Part 101 (21 CFR 101), as follows: 1. Your truweight & Energy Gen 2, truslumber, and renu products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. 343 (q)(1)(a)], because the serving size declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21

5 CFR 101.9(b) and 21 CFR (b) Table 2. For example, your truweight & Energy Gen 2 and renu product label directions of use suggest the consumer takes one or two capsules, but the serving size lists one capsule. 2. Your Complete Men s Multivitamin, Complete Women s Multivitamin, Omega 3, truslumber, Ubiquinol, renu, and truweight & Energy Gen 2 products are misbranded within the meaning of sections 403(q)(1)(B) [21 U.S.C. 343(q)(1)B] and 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the labels fail to declare the number of servings per container under the serving size on the left hand side of the nutrition label or fails to include this information as part of the net quantity of contents declaration in accordance with 21 CFR (b)(1)(ii). 3. Your renu, Omega 3, truslumber and truweight & Energy Gen 2 products are misbranded within the meaning of section 403(q)(5)(F) of the Act [U.S.C. 343(q)(5)(F)] because the labels fail to bear nutrition labeling in the form of a Supplement Facts label that is not in accordance with 21 CFR For example, The labels for your products renu and truslumber products lack a heavy bar beneath the subheading Serving Per Container, as required by 21 CFR (e)(6)(i). The label for truweight & Energy Gen 2 product fails to include a heavy bar beneath the last (b)(2)-dietary ingredient and beneath the last (b)(3)-dietary ingredient (other dietary ingredient), as required by 21 CFR (e)(6)(ii) and (iii). Furthermore, the other ingredients list must be located immediately below the Supplement Facts label, as required by 21 CFR 101.4(g). The labels for Omega 3 and truweight & Energy Gen 2 products each list (b)(2) -dietary ingredients that are present in amounts that can be declared as zero. However, any (b)(2) -dietary ingredients that are not present, or that are present in amounts that can be declared as zero in 21 CFR 101.9(c) (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals), must not be declared in Supplement Fact, as required by 21 CFR (b)(2)(i). The label for truslumbertm product bears the following or similar statement: Percent Daily Values based on a 2,000-calorie diet. This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein as required by 21 CFR 101.9(c) and 21 CFR (b)(2)(iii)(D). None of those dietary ingredients is present on the label, so the statement is not permitted. The labels for truslumber, renu and truweight & Energy Gen 2 products do not meet the requirements under 21 CFR (c)(2) and (c)(3), respectively in that the other dietary ingredients contained in the Proprietary Blend or other appropriate descriptive term are not declared in descending order of predominance by weight, and in a column or linear fashion and the labels for renu and truweight & Energy Gen 2 products fail to list the total weight of all other dietary ingredients contained in these Proprietary Blends in the Supplement Facts labels. 4. Your truweight & Energy Gen 2 and truslumber products are misbranded within the meaning of section 403(r)(6)(C) of the Act [21 U.S.C. 343(r)(6)(C)] because each product label makes structure function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR (b). 5. Your truslumber product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product is fabricated from two or more ingredients, but the label fails to bear the common or usual names of each ingredient used in the product, as required by 21 CFR

6 For example, the product label lists cyracos and Gaba Calm. The ingredients of your product must be listed by their common or usual names, as required by 21 CFR 101.4(a) and (h). We suggest that you review the requirements for designation of ingredients in 21 CFR and the general principles for common or usual names in 21 CFR 102.5(a) and (d) to help you determine how these ingredients should be declared on the label of your product. 6. Your truweight & Energy Gen 2 product is misbranded within the meaning of section 403(s) (2)(B) of the Act [21 U.S.C. 343(s)(2)(B)] because the label fails to identify the products using the term dietary supplement in accordance with 21 CFR 101.3(g). The label includes a Supplements Facts label, which is evidence of your intent to market the product as a Dietary Supplement, but the product s statement of identity does not comply with 21 CFR 101.3(g), which requires that a dietary supplement be identified by the term dietary supplement as part of the product s statement of identity, except the word dietary may be deleted and replaced by the name of the dietary ingredient in the product. 7. Your Complete Women s Multivitamin product is misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). We note the term Horsetail Extract (Aerial Parts) does not comply with this requirement. 8. Your truweight & Energy Gen 2 product is misbranded within the meaning of section 403(y) of the Act [21 U.S.C. 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Domestic address or domestic phone number means a complete address or phone number. (b)(3)(a) We have determined that your facility is (b)(3)(a). During the inspection of your facility located at South Business Park Drive, Suite 114, Draper, Utah from May 15, 22-25, and 30-31, 2017, you were (b)(3)(a). As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are following the law. (b)(3)(a) This letter is not an all-inclusive list of the violations that may exist at your facility or in connection with your products. It also does not indicate that FDA has conducted an all-inclusive review of all the products you manufacture and/or distribute. It is your responsibility to ensure the products you manufacture and/or distribute are following all applicable statutes and regulations, including the Act and applicable FDA regulations. You should take prompt action to correct all the violations noted in this letter and establish and implement procedures that will prevent the recurrence of these violations and the occurrence of other violations. Failure to implement lasting corrective actions may result in FDA taking regulatory action, including, without limitation, seizure or injunction. In addition, we note the following:

7 Your Complete Men s Multivitamin product label lists Vitamin B-5 within the Supplement Facts label. Likewise, your truweight & Energy Gen 2 product Supplement Facts label lists contains less than 2 Percent of the Daily Value of these nutrients and Manufactured in an NSF and GMP certified facility. Each of these text examples is considered intervening material per 21 CFR (b)(2) and 101.2(e). Your truslumber product label s placement of the TruVision name and address is not in accordance with 21 CFR All information required to appear on the label of any package of food under 21 CFR must appear either on the principal display panel or on the information panel. Your response to the FDA 483 issued to you at the close of the May 2017 inspection and, more specifically, your SOP D16.0 Finished Product Retain Sample Program does not provide a copy of your procedures for holding reserve samples. You are required to hold reserve samples in accordance with 21 CFR , including: Holding reserve samples of dietary supplements in a manner that protects against contamination and deterioration [21 CFR (a)], including: Holding reserve samples of dietary supplements under conditions consistent with product labels or, if no storage conditions are recommended on the label, under ordinary storage conditions [21 CFR (a)(1)]; Using the same container-closure system in which the packaged and labeled dietary supplement is distributed [21 CFR (a)(2)]; and Retaining reserve samples for 1 year past the shelf life date (if shelf life dating is used), or for 2 years from the date of distribution of the last batch of dietary supplements associated with the reserve samples, for use in appropriate investigations [21 CFR (b)]. Please respond to this office in writing within fifteen (15) working days from your receipt of this letter. In your response, identify the steps you have taken or will take to correct the above-noted violations and prevent similar ones. In your response, please include the timeframe in which the corrections will be completed and provide any documentation that will effectively assist us in evaluating whether the corrective actions have been made and the adequacy of such corrective actions. If you are unable to complete the corrective actions within fifteen (15) working days, identify the reason for the delay and the time within which you will complete the corrections. 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 after 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 mean 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. Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Hanna L. Potter, Compliance Officer, P.O. Box 25087, 6th Ave & Kipling St, Bldg 20 DFC, Denver, Colorado,

8 0087. You may reach Ms. Potter at (303) or via at if you have any questions about this matter. Sincerely, /S/ LaTonya M. Mitchell Denver District Director Program Division Director Office of Human and Animal Food Operations Division IV West More in 2017 (/ICECI/EnforcementActions/WarningLetters/2017/default.htm)