| Public Health Service Food and Drug Administration |
Minneapolis District Office |
Department of Health and Human ServicesSeptember 20, 2011
WARNING LETTER
OVERNIGHT MAIL
Refer to MIN 11 – 55
Gregory R. Palen, Chairman of the Board
Richard L. Blackader, Chief Operations Officer
Botanic Oil Innovations, Inc.
1540 S. River Street
Spooner, Wisconsin 54801
Dear Messrs. Palen and Blackader:
The Food and Drug Administration (FDA) conducted an inspection of your facility, located at 1540 S. River Street, Spooner, WI, on April 26-28, 2011. During the inspection, our investigators found a number of serious violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (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 supplements have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements.
In addition, during our inspection, we collected samples of labeling for several of your products, and we conducted a review of your websites, www.botanicoils.com and www.immunoviva.com, in September 2011. Our review of your labeling and websites determined that several of your Immuno-Viva products, including Immuno-Viva Core, Immuno-Viva Ease, and Immuno-Viva Boost, 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 on your website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your products with these claims violates the Act.
You may find the Act and related regulations through links on our website, www.fda.gov.
Dietary Supplement CGMP Violations
Based on the number of employees, your firm became subject to the dietary supplement CGMP regulations on June 25, 2010. The following are significant violations of these regulations:
1. Your firm failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of each dietary supplement that you manufacture, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of each dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e).
2. Your firm failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of a dietary supplement that you manufacture, and for each batch size, as required by 21 CFR 111.205(a). Our investigators found that you did not prepare or follow an MMR for any of your products.
3. Your firm failed to establish component specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1) and (b)(2), and failed to make and keep records of the established component specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.95(b)(1).
4. Your quality control operations did not review and approve all batch production-related records, as required by 21 CFR 111.123(a)(2). The batch production-related records (i.e., Record of Product Filled/Packaged, Seeds Processed Chart, Press Operations Hours) for the Core and Ease Immuno-Viva dietary supplement products were not approved, rejected, signed, or dated by your quality control personnel, and your firm did not keep written documentation that quality control personnel performed the review, approval, or rejection, as required by 21 CFR 111.140(b)(2).
5. Your firm failed to qualify suppliers of components other than dietary ingredients by establishing the reliability of the suppliers’ certificates of analysis through confirmation of the results of the suppliers’ tests or examinations, as required by 21 CFR 111.75(a)(2)(A).
6. Your firm failed to make and keep written procedures for product complaints, as required by 21 CFR 111.570(b)(1). Specifically, your firm did not have written procedures for the handling of any complaints regarding the dietary supplement products you manufacture and for adequately investigating complaints and documenting the findings of an investigation and follow-up.
7. Your firm failed to make and keep written procedures for returned dietary supplements, as required by 21 CFR 111.535(b)(1). Specifically, you did not have written procedures for handling any returned dietary supplement, including product reprocessing, product salvaging, or product destruction.
8. Your firm failed to make and keep records of the written procedures for packaging and labeling operations, as required by 21 CFR 111.430(b).
This letter acknowledges your response letters of May 16 and 31, 2011. These letters advised FDA of your firm’s commitment to correct the violations included in the FDA Form 483 and the hiring of a consultant to assist with the corrections. However, these letters did not provide evidence of actual corrective action for any of the violations listed above. We will evaluate any corrective actions taken to address these violations during our next inspection.
We also reviewed your responses to Observation 2 and 9 in the Form 483 and determined that they appear to be adequate. We will verify the adequacy of these corrective actions during our next inspection.
New Drugs
Your firm manufactures Immuno-Viva products, including Immuno-Viva Core, Immuno-Viva Ease, and Immuno-Viva Boost dietary supplements, which 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)].
Specific examples of claims in your product labeling that promote your products as drugs are as follows:
All Immuno-Viva products
(website at http://www.immunoviva.com)
o “Oxidative stress [otherwise known as free radical stress] has been linked to many conditions, including Parkinson's, Autism, Diabetes, Heart Disease, Rheumatoid Arthritis and Cancer, among others. . . . Studies show that one of the main benefits of antioxidants is their ability to reduce free radical stress. . . . All Immuno-Viva® products are packed with powerful antioxidants, and taking them as daily supplements can significantly reduce free radicals while providing specifically targeted health benefits.”
Immuno-Viva Core dietary supplement
(brochure)
o “Black cumin seeds [an ingredient in this product] contain nigellone, a natural antihistamine, and thymoquinone, which has anti-inflammatory properties.”
Immuno-Viva Ease dietary supplement
(website at http://www.immunoviva.com); brochure
o “Ease contains all natural red raspberry and black cumin seed oils extracted through our exclusive cold press process. Lab studies have shown that that these oils are Cox-2 inhibitors many times stronger than aspirin.”
o “Dr. Lucy Yu at the University of Maryland concluded in lab tests that both Immuno-Viva Ease ingredients are cox-2 inhibitors over 200 times stronger than aspirin, therefore offering powerful support for a healthy inflammation response.”
Immuno-Viva Boost dietary supplement
(website at http://www.immunoviva.com); brochure
o “Anti-microbial support”
o “Anti-viral support”
o “Boost offers much needed support for your immune system during cold and flu season . . . .”
o “Black cumin seed [an ingredient in the product] . . . found to support anti-histamine and anti microbial activity.”
o “Black Raspberry seed [an ingredient in the product] . . . known for its substantial health benefits including anti-inflammatory, anti-microbial and anti-viral activity.”
o “[S]tudies have shown that a diet rich in black raspberries can inhibit the growth of cancer cells in lab animals.”
o “The Journal of Clinical Oncology reported in 2006 a link between components of black cumin and the effective treatment of prostate cancer.”
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) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 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.
Furthermore, because your Immuno-Viva products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use these products safely for their intended uses. Thus, their labeling fails to bear adequate directions for their intended uses, causing these products to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].
This letter is not meant to be an all-inclusive list of violations at your facility or deficiencies that may exist in any of your product labeling. It is your responsibility to ensure that your establishment is in compliance with the Act and its implementing regulations.
Failure to promptly correct these violations may result in regulatory action without further notice. Such actions include seizure and injunction.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations. You should include in your response documentation such as revised labels or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within 15 working days, explain the reason for the delay and state when you will correct any remaining violations.
Your reply should be sent to the attention of Compliance Officer Tyra S. Wisecup at the address on the letterhead.
Sincerely,
/s/
Gerald J. Berg
Director
Minneapolis District
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