Good Herbs, Inc. 5/24/12
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Detroit District|
300 River Place
Detroit, Ml 48207
May 24, 2012
Mr. Brett C. Bashawaty, CEO
Good Herbs Inc.
550 Oliver Drive
Troy, MI 48084
Dear Mr. Bashawaty,
The U.S. Food and Drug Administration (FDA) inspected your facility, located at 550 Oliver Drive, Troy, Michigan 48084 from November 16, 2011 thru January 12, 2012. Because you label your products as dietary supplements, we evaluated whether the products were prepared, packed, and held under conditions that comply with FDA’s Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). During the inspection, our investigators found significant violations of the CGMP regulations for dietary supplements. 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 the CGMP regulations for dietary supplements in 21 CFR Part 111.
In addition, FDA reviewed the book entitled, A Practical Guide to Herbs that you distribute to all members upon the purchase of a membership that makes them eligible to purchase your products. Our review of this book determined that this book provides promotional material and labeling for your “AquaActive Tablets,” “Capsicum 90,” “IMB-T PLUS,” “Echinacea,” “HR-2,” “Olive Leaf,” “PARA-2-L” and “PO-K” products 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 in the book establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.
You may find the Act and related regulations through links in FDA's home page at www.fda.gov
Dietary Supplement CGMP Violations
The inspection revealed the following significant violations of the CGMP regulations for dietary supplements:
- You failed to establish specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(a) and to make and keep records of such specifications in accordance with 21 CFR 111.95. Specifically:
- You failed to provide documentation of an identity specification for each dietary ingredient that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b).
- You failed to provide documentation for product specifications for the identity, purity, strength, and composition of the finished batch of the following dietary supplements: PO-K batch #0105, HR-3 batch #0123 and PARA-2-L batch #0114, as required by 21 CFR 111.70(e).
In addition, we note that manufacturers are responsible for more than establishing specifications. Once you have established the specifications under 21 CFR 111.70, you must determine whether the specifications have been met [21 CFR 111.73].
- Your firm failed to conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, before being used as a dietary ingredient, as required by 21 CFR 111.75(a). You failed to provide documentation of identity testing for dietary ingredients, including Echinacea root powder, Olive Leaf, and Cayenne Pepper Powder.
- Your firm’s master manufacturing records (MMR) for the dietary supplement products PO-K batch #0105, HR-3 batch #0123 and PARA-2-L batch #0114 failed to identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplements and that the dietary supplements are packaged and labeled as specified in your MMR, as required by 21 CFR 111.205(b)(1). Your firm’s MMRs for these products failed to establish controls and procedures to ensure that each batch of dietary supplements that you manufacture meets the specifications identified, as required by 21 CFR 111.205(b)(2).
- Your firm’s batch production records (BPR) did not include complete information relating to the production and control of each batch and the requirements to be included in a batch record, as required by 21 CFR 111.255(b) and 111.260. Specifically, your firm’s BPR for your PO-K batch #0105, HR-3 batch #0123 and PARA-2-L batch #0114 dietary supplements did not include the following required information:
- The identity of the equipment and processing lines used in producing the batch, as required by 21 CFR 111.260(b).
- The date and time of the maintenance, cleaning, and sanitizing of 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).
- The identity and weight or measure of each component used [21 CFR 111.260(e)]
- A statement of the actual yield and percentage of theoretical yield at appropriate phases of processing, as required by 21 CFR 111.260(f). Specifically, the actual and theoretical yields after the blending and encapsulation operations were not listed on the batch records.
- Documentation that the finished dietary supplement meets specifications established in accordance with § 111.70(e) and (g), as required by 21 CFR 111.260(i).
- Documentation of the manufacture of the batch at the time of performance, as required by 21 CFR 111.260(j). Specifically, the following information was not documented in your BPR at the time of performance:
i. The date on which each step of the master manufacturing record was performed [21 CFR 111.260(j)(1)];
ii. The initials of the person responsible for weighing or measuring of each component used in a batch [21 CFR 111.260(j)(2)(i)];
iii. The initials of the person responsible for verifying the weight or measure of each component used in the batch [21 CFR 111.260(j)(2)(ii)];
iv. The initials of the person responsible for adding the component to the batch [21 CFR 111.260(j)(2)(iii)]; and
v. The initials of the person responsible for verifying the addition of components into a batch [21 CFR 111.260(j)(2)(iv)].
- Documentation at the time of performance of packaging and labeling operations, as required by 21 CFR 111.260(k).
i. The unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labels used, and reconciliation of any discrepancies between issuance and use of labels [21 CFR 111.260(k)(1)].
- Documentation at the time of performance that quality control personnel review of any monitoring operations, as required by 21 CFR 111.260(l)(1)(i).
- You failed to establish written procedures for quality operations as required by 21 CFR 111.103. Specifically, you have not established and followed written procedures for the responsibilities of the quality control operations to include procedure for conducting a material review, making dispositions, and approving or rejecting any reprocessing.
- You failed to establish written procedures for packaging and labeling operations as required by 21 CFR 111.403. Specifically, you have not established procedures for packing and labeling of any of the dietary supplements that you manufacture.
We acknowledge receipt of your response to the FDA-483, Objectionable Observations, dated January 25, 2012. We find your response to be inadequate because you have not provided any documentation supporting your proposed corrective actions.
Unapproved New Drugs
In your book, A Practical Guide to Herbs the following products were listed as a “remedy” for the medical conditions indicated:
- “high blood pressure”
Capsicum [an ingredient used in your Capsicum 90 product]
- “all heart problems, heart damage, arrhythmia, aneurysm”
- “heart attack”
- “stroke, capillary congestion …”
- “high or low blood pressure”
- “Buergers Disease”
- “brain damage”
- “restless leg syndrome”
- “prostate cancer”
- “erectile dysfunction”
Echinacea [an ingredient used in your IMB-T and PO-K products]
- ”bacterial and viral infections”
- ”use as an anti-microbial”
- ”chronic fatigue syndrome”
- “gum disease”
- “heart disease, congestive heart”
- “can be used for all heart problems”
- “cancer preventative”
- “use in first stages of cancer”
- “tumors, cancer, chronic fatigue, Aids”
- “preventative against flu, cols and other contagious diseases”
- “viral infections.”
Olive Leaf [an ingredient used in your PARA-2-L product]
- “venereal diseases including syphilis”
- “juvenile diabetes”
- “bacterial and viral infections including staph and strep”
- “toxic shock syndrome”
- “blood poisoning”
- “chemical poisoning, silicon breast implants”
- “nicotine removal”
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)]. 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. Under section 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. The introduction into interstate commerce of unapproved new drugs without approved applications violates these provisions of the Act.
Furthermore, your “AquaActive Tablets,” “Capsicum 90,” “IMB-T PLUS,” “HR-2,” “Olive Leaf,” “PARA-2-L” and “PO-K” products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, your product is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling fails to bear adequate directions for use. 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)].
You seek to avoid making drug claims by stating in your Member Wholesale Catalog (November 2011) “These products are not intended for diagnosis, treatment, cure, or prevention of any disease” along with language that states “For complete information, consult the book ‘A Practical Guide to Herbs’ . . . ..” Such a disclaimer does not negate the claim that the above-referenced products are intended for use as drugs. Adding a disclaimer or incorporating qualifying language in the labeling that effectively characterizes, for example, the treatment claims as not intended for treatment, is not a viable alternative because neither the disclaimer nor the qualifying language can rectify the message conveyed by the treatment claims. The use of claims in the labeling for the cure, mitigation, treatment, or prevention of disease, even with the attempt at a disclaimer, is evidence of intended use. Thus, such claims establish these products as drugs.
The above is not intended to be an all-inclusive list of violations in connection with your products. You should take prompt action to correct all violations. It is your responsibility to assure your firm complies with all requirements of the Act and FDA regulations. Failure to promptly correct these violations may result in legal action without further notice, including seizure and injunction.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific things that you are doing to correct the violations described above. You may include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and when you will complete the corrections.
Please send your reply to the Food and Drug Administration, Attention: CDR Kimberly Martin, Compliance Officer, 101 W. Ohio Street, Suite 500, Indianapolis, IN 46204. If you have questions regarding any issues in this letter, please contact CDR Martin at 317-226-6500 ext. 116.
Glenn T. Bass
Detroit District Office