Emmanuel W. Fan
- Westar Nutrition Corp. dba Viva Life Science, Inc.
350 Paularino Ave.
Costa Mesa, CA 92626
- 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
July 22, 2015
WL # 30-15
Mr. Emmanuel Fan, President
Westar Nutritional Corp. dba Viva Life Science, Inc.
350 Paularino Avenue
Costa Mesa, CA 92626
Dear Mr. Fan:
The United States Food and Drug Administration (FDA) conducted an inspection of your facility, Westar Nutrition Corp. dba Viva Life Sciences, Inc., located at 350 Paularino Avenue, Costa Mesa, California, on November 4, 5, 10, 13, and 18, 2014. 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 the dietary supplement products Viva Kids Plus, Viva Ez Kids, B-Easy, LipoGuard, and SelGuard 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 collected at the inspection as well as your website at www.vivalife.com.
Based on our review of your product labeling, we found serious violation of sections 505(a) and 502(f)(1) of the Act [21 U.S.C. §§ 355(a), and 352(f)(1)] 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
We also have received your written response dated December 4, 2014, concerning our investigator’s observations noted on the Form FDA 483, Inspectional Observations, which was issued to you on November 18, 2014. Our comments regarding the actions you took to correct the objectionable conditions and practices observed during the inspection are detailed after the applicable violations, noted below.
The significant violations documented during the inspection include, but are not limited to, the following:
Unapproved New Drugs/Misbranded Drugs
We reviewed your website at www.vivalife.com in February, March, and June 2015 and have determined that you take orders there for your LipoGuard and SelGuard products. 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 uses as drugs include:
(1) LipoGuard: http://www.vivalife.com/cardiovascular/lipoguard-fish-oil-omega-3-120-softgels.html
“An FDA report cites the LipoGuard® study by Dr. Morcos as the only one out of 24 comparisons to actually lower LDL (bad) cholesterol in clinical test subjects. See Morcos 1997 reference on Table 2 of the report for results. http://vm.cfsan.fda.gov/~dms/ds-ltr11.html*”
(2) SelGuard: http://www.vivalife.com/selguard-selenium-200mcg-60-tablets.html
“A clinical study on SelGuard™ has been published in the peer-reviewed journal, Anticancer Research, and the abstract was presented at the 1999 Annual Convention of the American Association of Cancer Research (AACR).”
Further, your website cites a pair of clinical studies, under the “Nutritional Science” link on your home page, suggesting the use of your LipoGuard and SelGuard products to treat diseases. When scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product’s intended use as a drug. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a dietary supplement is considered to be a claim about disease treatment or prevention if the citation refers to a disease use, and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease.
The following reference citations on your website are among those used to market SelGuard and LipoGuard for disease treatment and prevention:
- Vadgama, Jaydutt V., Wu, Yanyuan, Shen, Dujun, Hsia, S. and Block, Jerome. Effects of Selenium in Combination with Adriamycin or Taxol on Seven Different Cancer Cells. Anticancer Research. 20: 1391-1414 (2000), http://www.vivalife.com/media/catalog/product/pdf/Selguard_Study_bw.pdf
- Morcos, N.C. LipoGuard Clinical Study, http://www.vivalife.com/media/catalog/product/pdf/LipoGuard_Study.pdf
The reference citation to the study by Vadgama et al. implies that SelGuard can treat or prevent cancer. The reference citation to the Morcos study uses key words such as “coronary artery disease,” “heart disease,” “cholesterol lowering and improvement,” and “antiatherosclerotic properties” to describe the study and expresses your LipoGuard product can treat or prevent coronary artery disease.
Your LipoGuard and SelGuard products are not generally recognized as safe and effective for the above referenced uses and, therefore, the productsare 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 submitted by a drug sponsor to demonstrate that 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 C.F.R. § 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 LipoGuard and SelGuardproducts are intended for prevention or treatment of one or more diseases that are not amenable to self-diagnosis and treatment; therefore, it is impossible to write adequate directions for a layperson to use these products safely for their intended purposes. Accordingly, your LipoGuard and SelGuard aremisbranded within the meaning of section 502(f)(1) of the Act. 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
The inspection revealed the following 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 which do not meet the CGMP regulations for dietary supplements.
1. You failed to provide adequate documentation of your basis for determining that compliance with the specifications selected under 21 CFR 111.75(c)(1), through the use of appropriate tests or examinations conducted under 21 CFR 111.75(c)(2), would ensure that your finished batches of Viva Ez Kids and B East dietary supplements meet all product specifications for identity, purity, strength, and composition, and the limits on those types of contamination that may adulterate or that may lead to the adulteration of the dietary supplement, as required by 21 CFR 111.75(c)(3). Under 21 CFR 111.75(c)(1), you must select one or more established specifications for identity, purity, strength, composition, and the limits on those types of contamination that may adulterate or that may lead to adulteration of the dietary supplement that, if tested or examined on the finished batches of the dietary supplement, would verify that the production and process control system is producing a dietary supplement that meets all product specifications. Under 21 CFR 111.75(c)(2), you must conduct appropriate tests or examinations to determine compliance with the specifications selected under 21 CFR 111.75(c)(1). For example, you did not provide documentation for your basis for determining that meeting the specifications for vitamin C and Calcium in your Viva Ez Kids, Lot (b)(4) product would ensure that the specifications for vitamins A and E or the minerals Iron, Zinc, or Selenium were met.
We have reviewed your response letter dated December 4, 2014, but we are unable to determine the adequacy of your response. You stated that you have procedures in place that test for all label claims for the initial two batches of a final product. You also stated that you test “representative claims” followed by testing of all label claims in succession until the sixth batch. Your response did not provide documentation of your basis of testing “representative claims” to ensure that your finished batch of the dietary supplement meets all product specifications for identity, purity, strength, and composition. Neither did your response provide testing records for the Viva Ez Kids, Viva Kids Plus, and B-Easy products that you stated were tested for all labeled claims.
2. You failed to establish specifications for the identity of each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1). You also failed to establish component specifications that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2). Specifically, your firm failed to establish identity, purity, strength and composition specifications for the components Zinc Gluconate and Cyanocobalamin used in the manufacture of various dietary supplement in your facility.
We have reviewed your response letter dated December 4, 2014, but we are unable to determine the adequacy of your response because it does not provide specifications that you test for your components. In addition, your revised procedure provided with your response, QC-EXP (RM), Retesting and Re-rereleasing of Raw Materials, effective 12/3/2014, only requires an assay test to extend expiration dates. The revised procedure allows for re-testing and re-releasing of raw materials if they have expired or will soon expire. The documentation provided does not explain what specifications will be tested for the raw materials it handles and does not provide specifications of raw materials that it will test as part of the firm’s re-testing and re-releasing program of expired or soon to be expired raw material. Also, we noted that section VI, Microbiological Lab OOS Results of your procedure QCL-OOS “Handling ‘Out of Specifications” Results,” effective 12/3/2014, provided with your response allows for retesting of microbiological samples that do not meet specification without proper justification. This is considered testing into compliance and is not acceptable. All failures should be properly investigated prior to ruling out a testing error. Microbiological contamination is typically not uniform, and sample results from the same lot may vary.
3. You failed to establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specifications that ensure that you used the specified packaging and that you applied the specified label, as required by 21 CFR 111.70(g). Specifically, your finished product specifications do not include specifications for the packaging and labeling of your finished dietary supplements.
We have reviewed your response letter dated December 4, 2014, including your product specifications for the products SelGuard and Viva Kids Plus. We are unable to determine the adequacy of your response because it lacks the following detailed packaging and labeling specifications: the size, weight, dimensional design; test methods or standards to be used; and what constitute nonconformities and internal cleanliness.
4. Your firm’s master manufacturing records failed to establish controls and procedures to ensure that each batch of dietary supplements that you manufacture meets the specification identified in accordance with 21 CFR 111.205(b)(1), as required in 21 CFR 111.205(b)(2). Specifically, your firm’s master manufacturing records (MMRs) for B-Easy, SelGuard, and Viva Kids Plus failed to include the following required information:
- The identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts Panel and the identity of each ingredient that will be declared on the ingredient list of the dietary supplement [21 CFR 111.210(d)];
- A description of packaging [21 CFR 111.210(g)];
- Specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR (for example, the amount and unit of pressure needed to compress the tablet is not specified on the MMR from the tableting machine during the tableting operation) [21 CFR 111.210(h)(1)];
- Procedures for sampling and a cross reference to procedures for tests or examinations [21 CFR 111.210(h)(2)];
- Corrective action plans for use when a specification is not met [21 CFR 111.210(h)(5)]
We have reviewed your response letter dated December 4, 2014, including the revised MMRs you’ve submitted. We are unable to determine the adequacy of your response because the MMRs you submitted failed to include the above-noted, required information.
5. Your firm failed to establish a batch production record (BPR) that includes the specific information required by 21 CFR 111.260, as required by 21 CFR 111.255. Specifically, your BPRs did not include the following required information:
- The date and time of maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records, such as individual equipment logs, where this information is retained, as required by 21 CFR 111.260(c). For example, your BPRs for LipoGuard Lot (b)(4), Viva EZ Kids Lot (b)(4), and Viva Kids Plus Lot (b)(4) failed to include this information.
- The unique identifier that you assigned to each packaging and label used [21 CFR 111.260(d)].
- The identity of equipment and processing lines used in producing the batch, as required by 21 CFR 111.260(b). For example, the BPR for your Viva EZ Kids, Lot (b)(4) did not identify the (b)(4) piece of equipment in step (b)(4) of your procedure and the BPR for your LipoGuard, Lot (b)(4) did not identify the (b)(4) in steps (b)(4) and (b)(4), respectively.
- Complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b). For example, you failed to record the blending times in step (b)(4) of your BPR for the Viva EZ Kids Lot (b)(4) and in step (b)(4) of your BPR for Viva Kids Plus Lot (b)(4).
We have reviewed your response letter dated December 4, 2014, including the SOP #PDN-003 that includes a procedure “to attach a copy of the equipment cleaning and usage log to the formula of the batch processed.” We cannot determine the adequacy of your response because your written response did not include supporting documentation to show that you have implemented this procedure.
The violations cited in this letter are not an intended to be an all-inclusive statement 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 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 injunction.
In addition, we note that you include expiration dates on the labels of your firm’s finished dietary supplement products, including your B-Easy, Viva Kids Plus and Viva Ez Kids products. The “Shelf-Life Stability Report” for the “Viva Kids Plus” product shows strength specifications were not met for Vitamin E at 12 months and 24 months and Vitamin A at 24 months. Your report indicates this was due to precision of the method; however, no further information was included to support that conclusion. We also note that your “Shelf-Life Stability Report” for these does not account for the age of the raw materials used in the study. You have not evaluated the effect of extending raw material expiration dates on your finished product shelf life. Any expiration date that you place on a product label should be supported by data. See 72 Fed. Reg. 34752, 34856 (June 25, 2007).
Within fifteen working days of your 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 the 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.
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.
Your response should be sent to:
CAPT Daniel Cline
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.
Alonza E. Cruse, Director
Los Angeles District
David M. Mazzera, Chief
Food and Drug Branch
California Department of Public Health
PO Box 997435
1500 Capitol Ave., MS-7602
Sacramento, CA 95899-7413
Attn: FDA Correspondence
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