Carmen P. Bickell
- Vitalife Inc.
11258 Monarch St., Ste. L
Garden Grove, CA 92841
- Issuing Office:
- Los Angeles District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
June 20, 2016
WL # 33-16
Ms. Carmen P. Bickell, Owner
Vitalife Inc. dba Tabak’s Health Products
11258 Monarch St., Ste. L
Garden Grove, CA 92841
Dear Ms. Bickell:
The United States Food and Drug Administration (FDA) conducted an inspection of your facility, Vitalife Inc. dba Tabak’s Health Products, located at 11258 Monarch St., Ste. L, Garden Grove, CA 92841, on December 15, 16, and 18, 2015. The inspection revealed serious violations of FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under 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 they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
Additionally, we have reviewed your product labels and your website at www.tabakshealthproducts.com
. Based on our review of your product labeling, we found serious violation of section 505(a) of the Act [21 U.S.C. § 355(a)] and the regulations implementing the food labeling requirements of the Act, which are found in 21 CFR part 101. You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov.
The significant violations documented during the inspection include, but are not limited to, the following:
Unapproved New Drug Violations
We reviewed your website at the Internet address www.tabakshealthproducts.com
in March 2016 and have determined that you take orders there for the products Bendy, ExtraLuvli, and Graceful Look. The claims on your website establish that the products are drugs under section 201(g)(1)(B)/(C) of the Act [21 U.S.C. § 321(g)(1)(B)/(C)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease
and/or to affect the structure or any function of the body of man or other animals. 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 uses as drugs include:
- “Protect your skin against the harmful effects of UV radiation and sun damage.”
- “Helps to decrease UV-induced pigmentation.”
- “Vitamin K exerts an anti-inflammatory effect on skin.”
Yourproducts 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 sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
Dietary Supplement CGMP Violations
The December 2015 inspection of your facility revealed significant violations of the CGMP requirements for dietary supplements. These violations cause your dietary supplement products to be adulterated under section 402(g)(l) of the Act [21 U.S.C. § 342(g)(l)] in that they have been prepared, packed, or held under conditions that do not meet the CGMP regulations 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, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103 and 21 CFR 111.140(b)(1). Specifically, the documentation you maintain for the purpose of conducting a material review and making a disposition decision is inadequate because it does not address procedures such as approving or rejecting all processes, specifications, written procedures, controls, tests, and examinations, and deviations from or modifications to them, that may affect identity, purity, strength, or composition of a dietary supplement; reviewing and approving the documentation setting forth the basis for why meeting in-process specifications, in combination with meeting component specifications, will help ensure that the identity, purity, strength, and composition of the dietary supplement are met; and reviewing and approving the documentation setting forth the basis for why the results of appropriate tests or examinations for each product specification will ensure that the finished batch of the dietary supplement meets product specifications.
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 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 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 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 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)].
We have received your response letter dated January 8, 2016; however, we are unable to evaluate the adequacy of your corrective action. Specifically, your response states that you will review your written procedures, but your response does not explain how you plan to revise your procedures to comply with the relevant requirements for establishing and following written procedures for the responsibilities of quality control operations.
2. You failed to establish component specifications that are necessary to ensure that specifications for the identity, purity, strength and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b). Specifically, you do not have specifications for identity, purity, strength, and composition for the following components that you purchase for use by your contract manufacturers: Zinc Methionine (b)(4) Eurycoma Longifolia Ext (b)(4), Maca Root (b)(4), and Black Pepper (b)(4), used to produce your Arouser, lot number (b)(4); and Biotin (b)(4), Saw Palmetto Berry (b)(4), Horsetail (b)(4), Vitamin A 20% Beta carotene, Vitamin B3 (b)(4) Niacinamide, Vitamin B6 (b)(4) Pyridoxine HCL, Vitamin B12 (b)(4), 72 Trace Mineral Blend, B-sitosterol (b)(4), Silicon ((b)(4) Chelate (b)(4)), and Folic Acid Vitamin D3(b)(4), used to produce your Here-We-Grow, lot number (b)(4).
Once you have established component specifications and before using a component, you must ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1), and you must make and keep records of the specifications established, as required by 21 CFR 111.95(b)(1).
We have received your response letter dated January 8, 2016; however, we are unable to determine the sufficiency of your corrective action. Your response included a document titled “Raw Materials Specifications And Purchasing Guidelines.” This document did not provide evidence of established component specifications for identity, purity, strength, and composition of the components used in your Arouser and Here-We-Grow dietary supplement products.
3. You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, you have not established finished product specifications for your Arouser and Here-We-Grow dietary supplement products.
We have received your response letter dated January 8, 2016; however, we are unable to determine the sufficiency of your corrective action. Your response did not provide any further information regarding how you determine your dietary supplement products meet finished product specifications.
4. You failed to periodically re-confirm the supplier’s certificate of analysis (COA) for applicable component specifications, as required by 21 CFR 111.75(a)(2)(ii)(D). Specifically, your firm relies on the suppliers' COA to meet all component specifications and required examination and/or analysis; however your firm has not performed any type of testing to re-confirm the reliability of the supplier’s COA after initial qualification.
We have received your response letter dated January 8, 2016; however, we are unable to determine the adequacy of your corrective action. Your response states that prior to the “move,” all suppliers were re-qualified; however, you provided no documentation to clarify or support this statement. Please note that in accordance with 21 CFR 111.75(a)(2)(ii)(A) – (E), you may rely upon a certificate of analysis from the supplier of a component that you receive, provided that:
a. You first qualify the supplier by establishing the reliability of the supplier’s certificate of analysis (COA) through confirmation of the results of the supplier’s tests or examinations;
b. The certificate of analysis includes 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. You maintain documentation of how you qualified the supplier;
d. You periodically re-confirm the supplier’s certificate of analysis; and
e. Your quality control personnel review and approve the documentation setting forth the basis for qualification (and re-qualification) of any supplier.
Dietary Supplement Labeling Violations
Your “Arouser” and “Here-We-Grow” dietary supplement products are misbranded under section 403 of the Act [21 U.S.C. §343] because the products do not comply with the labeling requirements for dietary supplements. The inspection revealed the following violations of labeling requirements for dietary supplement:
1. Your “Arouser” and “Here-We-Grow” 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 label is 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 CFR 101.9(h) and 21 CFR 101.12(b) Table 2. Specifically, your “Arouser” product states to consume “one (1) tablet in the morning and one (1) tablet in the evening,” but the serving size lists “Two (2) Tablets.” The serving size should be 1 Tablet. In addition, your “Here-We-Grow” product states to consume “one (1) capsule in the morning and one (1) capsule in the evening,” but the serving size lists “Two (2) Capsules.” The serving size should be 1 Capsule.
2. Your “Here-We-Grow” product is misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the nutrition information does not comply with 21 CFR 101.36. For example, the product label declares Vitamin B3 (as Niacinamide) as a dietary ingredient although the common and usual name is niacin in accordance with 101.36(b)(2) and 101.9(c)(8)(iv). Furthermore, the product label declares the ingredient “72 Trace mineral blend,” which is not the common or usual name of each dietary ingredient in the blend. All of the minerals should be listed by the common or usual name in accord with 21 CFR 101.36.
3. Your “Arouser” and “Here-We-Grow” products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label of each product 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).
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 that your firm complies with all requirements of federal law, including 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 injunction.
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover the 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 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, the FDA may assess fees to cover any reinspection-related costs.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your response should be sent to:
CAPT Larry Howell
Acting Director, Compliance Branch
Food and Drug Administration
Irvine, CA 92612-2506
If you have any questions about the content of this letter, please contact Marco Esteves, at 949-608-4439.
CDR Steven E. Porter, Jr.
Los Angeles District Director
David M. Mazzera, Ph.D.
Chief, Food and Drug Branch
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
Sacramento, CA 95899-7413
 As defined in 21 CFR 101.93(g)(1), a “disease” is “damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition.”
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