- Delivery Method:
- Overnight Delivery
- Dietary Supplements
Robert W. Matheson
- Berkeley Nutritional Mfg Corp.
1852 Rutan Drive
Livermore, CA 94551-7635
- Issuing Office:
- San Francisco District Office
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
January 31, 2017
Return Receipt Requested
Mr. Robert W. Matheson, President/CEO
Berkeley Nutritional Manufacturing Corporation dba Protein Research
1852 Rutan Drive
Livermore, CA 94551-7635
Dear Mr. Matheson:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, located at 1852 Rutan Drive, Livermore, CA 94551-7635 from February 18, 2016 through March 4, 2016. We found serious violations of the Current Good Manufacturing Practice (CGMP) regulations for 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 identified below 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 requirements for dietary supplements.
Additionally, we reviewed the labeling of dietary supplement products collected during the inspection of your facility. Based on our review, we found serious violations of sections 402(f) and 413(a) of the Act [21 U.S.C. § 342(f) and 350b(a)]], section 403 of the Act [21 U.S.C. §
343], sections 505(a) and 502(f)(1) of the Act [21 U.S.C §§ 355(a), and 352(f)(1)]. You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.
Unapproved New Drug Violations
This is to advise you that the Food and Drug Administration (FDA) reviewed the product labels for the (b)(4) and Magnesium Malate products. The claims on the product labels establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (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 on the product labels that provide evidence that the products are intended for use as drugs include:
(b)(4) and Magnesium Malate 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)]. 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.
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.
The product (b)(4) is intended for 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 your product safely for its intended purposes. Accordingly, (b)(4) product fails to bear adequate directions for its intended use and, therefore, the product is 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 this misbranded drug violates 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.
We acknowledge the receipt and have reviewed your Form FDA 483 written response letter submitted on March 22, 2016. The written responses for the violations cited on the Form FDA 483 issued on March 4, 2016 appear to be inadequate. We are concerned of your failure to establish and implement effective corrective actions.
1. Your firm failed to establish specifications for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement, as required by 21 CFR 111.70:
a) You failed to establish an identity specification for each component used in the manufacture of a dietary supplement as required by 21 CFR 111.70(b)(1). Specifically, you did not establish identity specifications for the Biotin (b)(4) and Dicalcium Phosphate Dihydrate components you use in the manufacture of the (b)(4) dietary supplement product.
b) You failed to establish component specifications that are necessary to ensure that the specifications for purity, strength, and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2). Specifically, you have not established specifications for the Biotin (b)(4) and Dicalcium Phosphate Dihydrate components that ensure the (b)(4) dietary supplement product meets the final product specifications.
Once you have established component specifications and before using a component, you must conduct at least one appropriate test or examination to verify the identity of the dietary ingredient prior to its use, as required by 21 CFR .75(a)(1)(i), unless you petition the agency for an exemption under 21 CFR 111.75(a)(1)(ii) and the agency exempts you from such testing, and you must confirm the identity of other components and determine whether other applicable component specifications established in accordance with 21 CFR 111.70(b) are met , as required by 21 CFR 111.75(a)(2). A Certificate of Analysis may not be used in lieu of an identity test. You must also 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
We have reviewed your response letter, dated March 22, 2016, and determined your response to be inadequate. Your response letter provided component specifications regarding identity, purity, strength, and composition for only some components used to manufacture the (b)(4) dietary supplement product. Your response did not include component specifications for the Biotin (b)(4) and Dicalcium Phosphate Dihydrate.
Dietary Supplement Labeling Violations
The (b)(4) dietary supplement product is misbranded under section 403 of the Act [21 U.S.C. §343] because the product does not comply with the labeling requirements for dietary supplements. The inspection revealed the following violations of labeling requirements for dietary supplements:
1. The (b)(4) 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 product label fails to identify the product using the term ”dietary supplement” in accordance 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 or an appropriately descriptive term.
2. The (b)(4) 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).
3. The (b)(4) product is misbranded within the meaning of section 403(g)(1) of the Act [21 U.S.C. 343(g)(1)] because the product does not conform to the definition and standard for chocolate as noted in 21 CFR 163.110 (Requirements for Standardized Cacao Products). Your product label indicates the term “chocolate” in the product name as well as in the nutrition information with the listing of “chocolate blend”. We note the word “chocolate” in the phrase (b)(4) is in a print size that is significantly larger than the phrase in which it appears, so as to give prominence to the word “chocolate.” We do note the listing of “natural chocolate flavoring” in the nutrition information. However, the product label listing of “chocolate blend” and “chocolate” appears to imply the product contains chocolate. The terms "chocolate flavored" or "natural chocolate flavored" rather than the term “chocolate” or “chocolate blend” must be used on the labeling of any nonstandardized food in which the consumer could reasonably expect a chocolate ingredient but which contains cocoa as the sole source of chocolate flavoring.
The above violations are not intended to be an all-inclusive list of violations at your facility or that exist in connection with your products or their labeling. 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 all the products you manufacture or distribute meet all of the requirements of the Act and its implementing 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, such as seizure and/or injunction.
Please be advised a description of the new drug approval process can be found on FDA's internet website at http://www.fda.gov/cder/regulatory/applications/default.htm
. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857.
In addition to the above violations, we have the following comments:
The presentation of nutrition information in the supplement facts label for the (b)(4) product is not in accordance with 21 CFR 101.9 and 101.36. For example:
Please respond to this letter in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations listed above and to prevent similar violations in the future. Your response should include any documentation necessary that would assist us in evaluating your corrections. 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.
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 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 written response should be sent to Lawton W. Lum, Director of Compliance at the address noted above and reference unique identifier 500324. If you have any questions concerning this letter, please contact Compliance Officer Lance De Souza at (510) 337-6873.
Darla R. Bracy
Acting District Director
San Francisco District