Inspections, Compliance, Enforcement, and Criminal Investigations
AHN International Inc DBA Amazing Herbs Nutraceuticals 10/2/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Atlanta District Office|
60 Eighth Street N.E.
Atlanta, GA 30309
October 2, 2012
Waseem G. Goreja, President
AHN International, Inc.
d/b/a Amazing Herbs Nutraceuticals
2709 Faith Industrial Drive
Buford, GA 30518
Dear Mr. Goreja:
On May 23-30, 2012, an FDA investigator conducted an inspection of your dietary supplement manufacturing, repacking, and distributing firm located at 2709 Faith Industrial Drive in Buford, GA. The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for dietary supplements, found in Title 21 of the Code of Federal Regulations Part 111 (21 CFR Part 111). These violations render your dietary supplements adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) § 342(g)(1)], in that the products were prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements. Many of these violations were also observed by FDA investigators during an inspection conducted February 25-March 2, 2011, as documented in the FDA 483, Inspectional Observations, that you were issued at the close of that inspection.
With regard to your black seed and bitter melon products, we reviewed your product· labeling, including your website at www.amazingherbs.com in July 2012, and other evidence of the intended use of the products, including books for sale on your website. As described further in this letter, the manner in which you promote these products cause them to be unapproved new drugs, which is in violation of Section 301(d) and Section 505(a) of the Act [21 U.S.C. § 331(d) and § 355(a)].
You may find the Act and pertinent FDA regulations through links on FDA's website at www.fda.gov.
Unapproved New Drugs/Misbranded Drugs
Your "Bitter Melon" and "Black Seed" products are promoted for conditions that cause the products to be drugs under Section 201(g)(l) of the Act [21 U.S. C. § 321(g)(l)]. The therapeutic claims on your website www.amazingherbs.com and books "Bitter Melon: Nature's Anti-Diabetic" and "Black Seed: Nature's Miracle Remedy" establish that your 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.
Examples of claims include the following:
Bitter Melon Products
The following claim is among those made on your website at www.amazingherbs.com:
• "[T]housands of individuals already use Bitter Melon as an alternative herbal remedy to treat diabetes ... and as an anti viral agent."
The following claims are among those made in your book entitled, Bitter Melon: Nature's Anti-Diabetic:
• "[T]housands of individuals already use Bitter Melon as an alternative herbal remedy to treat diabetes ... and as an antiviral agent, particularly in HIV/AIDS."
• "Bitter Melon is drunk as a traditional remedy for diabetes, to treat malaria and associated fevers, as an anti-inflammatory in rheumatic diseases, for jaundice and other liver conditions, and to treat kidney stones and gout. It is also used ... as a contraceptive. Applied topically, it is used to treat eczema, snakebites, leprosy, piles, psoriasis and scabies ... "
• "The leaves of the Bitter Melon plant ... are used to make a "blood purifying" tea. This tea is also used to treat diabetes ... hypertension (high blood pressure) and as an anti-inflammatory in treating malaria ... "
• "The best-described and most widely documented medicinal use for Bitter Melon is in the treatment of diabetes mellitus. Its mode of action as a therapeutic ... is to lower blood sugar levels, otherwise referred to as having a hypoglycemic effect."
• "Bitter Melon is ... used to treat Type 2 non-insulin dependent diabetes mellitus."
• "Bitter Melon... [has] been shown to exhibit antiviral activity against a number of virus pathogens ... including Epstein-Barr, herpes, and HIV."
• "Bitter Melon supplements ... are employed by natural health practitioners for diabetes, viruses, colds and flu, and psoriasis."
The following claim was made on the label of your Amazing Herbs GlyMordica® Bitter Melon product:
• "GlyMordica® is an all natural sugar-diabetes support supplement made from Bitter Melon ... "
Black Seed Products
The following claims are among those made on your website at www.amazingherbs.com:
• "Garlic supports healthy cholesterol levels by reducing serum cholesterol."
• ''Nigella Sativa [another name for Black Seed] is cultivated for its seeds, which long been used to treat such ailments as asthma ... polio, ... pain ... "
• "Black seed remains a traditional remedy for asthma ... pain ... and cancer ... "
• "[T]raditional uses for Black Seed ... Heart Disease ... Hypertension ... Diabetes ... Meningitis ... "
• "[A] natural enhancement of immunity in the treatment of cancer, AIDS and other cases of immunity deficiency."
The following claims are among those made in your book entitled, Black Seed: Nature's Miracle Remedy:
• "Black Seed's benefits are so diverse that ... it is very nearly a cure-all."
• "Black Seed in the treatment of such fatal diseases as cancer and AIDS."
• "[M]odem uses of Black Seed, including the treatment of.. .hypertension, cancer, HIV/AIDS ... "
• "Black Seed heals every disease except for death."
• "[I]t has proved valuable against such fatal diseases as cancer and AIDS."
• "[B]lack Seed is a potent antihistamine, anti-tumor, antibacterial, and anti-inflammatory agent ... "
• "[B]lack Cumin Oil (Black Seed) an ideal candidate for use in cancer prevention and cure."
• "Black Seed has proven highly effective ... with tumors that show resistance to current anti-tumor drugs."
• "Black Seed's antioxidant properties ... useful against hypertension and other cardiovascular disorders."
• "Hypertension ... Black Seed helps lower blood pressure in a variety of ways."
• "Black Seed also works as an anti-tumor agent, and when used in conjunction with chemotherapy, the herb works to reduce side effects of the treatment ... "
• "From cancer-fighting properties to antioxidants to antihistamine agents - all elements in the herb combine for unparalleled healing effects."
• "Black Seed is such an exceptional daily preventative from everything from the common cold to cancer."
Your bitter melon and black seed products are not generally recognized as safe and effective for the above referenced uses and therefore, 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, your bitter melon and black seed 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)(l )], 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)].
Adulterated Dietary Supplements
As indicated above your bitter melon and black seed products, as marketed, are considered unapproved new drugs and misbranded drugs. If these and the other products manufactured, repackaged, and/or distributed by your firm were dietary supplements, they would be adulterated within the meaning of Section 402(g)(1) of the Act [21 USC § 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet the current good manufacturing practice regulation for dietary supplements found in 21 CFR Part 111.
The following serious violations of the CGMP for dietary supplements were observed during our inspection:
1. You failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to its use, as required by 21 CFR 111.75(a)(1)(i).
Specifically; you used black seed oil and flax seed oil from bulk shipments in your Amazing Herbs Black Seed Cold-Pressed Oil and Amazing Herbs Black Seed & Flax Seed Oil Blend products, without conducting and documenting at least one appropriate test or examination to verify the identity of each of these dietary ingredients.
2. You failed to prepare and follow a written master manufacturing record for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a).
Specifically, you did not prepare a master manufacturing record for each batch size of the dietary supplements you manufacture, including your Amazing Herbs Black Seed Cold-Pressed Oil, Amazing Herbs Black Seed & Flax Seed Oil Blend, and Amazing Herbs Black Seed & Pumpkin Seed Oil Blend products.
3. You failed to prepare a batch production record every time you manufacture a batch of a dietary supplement, as required by 21 CFR 111.255(a).
Specifically, between 2011 and 2012, you produced over (b)(4) bottles of products, including your Amazing Herbs Black Seed Cold-Pressed Oil, Black Seed & Flax Seed Oil Blend, and Black Seed & Pumpkin Seed Oil Blend products. However, you did not prepare batch records to accompany any batch produced.
4. Your quality control personnel failed to perform operations that include approving or rejecting all processes, specifications, written procedures, controls, tests, and examinations, and deviations from or modifications to them, that may affect the identity, purity, strength, or composition of a dietary supplement, as required by 21 CFR 111.105(a).
Specifically, you do not have any processes, specifications, written procedures, tests, or examinations that have been reviewed and approved by quality control.
5. Your quality control operations for the master manufacturing record, the batch production record, and manufacturing operations failed to include approving and releasing, or rejecting, each finished batch for distribution, including any reprocessed finished batch, as required by 21 CFR 111.123(a)(8).
Specifically, you failed to maintain any documentation that each finished batch of dietary supplement was reviewed and approved by quality control prior to release and distribution.
6. Your quality control operations for product complaints failed to include reviewing and approving decisions about whether to investigate a product complaint and reviewing and approving the findings and follow-up action of any investigation performed, as required by 21 CFR 111.135.
Specifically, between 12/23/2011 and 05/08/2012, you were notified of at least eight (8) product complaints involving your products. However, you have not documented that quality control personnel reviewed or approved any decisions whether to investigate any of your complaints, or reviewed or approved any investigations or follow-up actions.
7. You failed to destroy, or otherwise suitably dispose of, any returned dietary supplement unless the outcome of a material review and disposition decision is that quality control personnel approve the salvage. of the returned dietary supplement for redistribution or approve it for reprocessing, as required by 21 CFR 111.515.
Specifically, you hold onto returned dietary supplements that have not been approved by quality control for salvage or reprocessing. Additionally, your firm does not maintain written procedures for quality control personnel regarding the review and disposition of returned dietary supplements.
We have reviewed your June 15, 2012 written response to the form FDA 483, Inspectional Observations, you were issued at the close of the inspection, and determined that the response is inadequate in that it lacks any documentation or detailed corrective actions to the violations noted during the inspection.
This letter is not intended to be an all-inclusive list of violations. You are responsible for ensuring that your firm is operating in compliance with all requirements of the Act and pertinent FDA regulations, such as the dietary supplement regulations (21 CFR Part 111). You can find. copies of the Act and pertinent regulations through links on FDA's homepage at www.fda.gov.
You should take prompt action to correct all of the violations noted in this letter and establish and implement procedures that will prevent these and other violations in the future. Failure to promptly correct these violations may result in FDA taking regulatory action, such as seizure or injunction, without further notice.
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 determining 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.
In addition to the violations cited above, we note the following:
• You did not prepare and keep written procedures that include those for preventing microbial contamination from sick or infected personnel, for hygienic practices, and for personnel qualification requirements, as required by 21 CFR 111.14(b)(1). Specifically, you did not prepare and keep records on procedures for preventing microbial contamination related to: employee's health condition, proper wear of outer garments, through hand washing, removal of jewelry prior to working with ingredients, maintaining gloves used in handling of components, wearing hair restraints, storing clothing, no eating, and other steps that would protect against contamination.
Please respond to this office in writing within fifteen (15) working days from your receipt of this letter. In your response, identify the steps you have taken or will take to correct the above noted violations and prevent similar ones. In your response, please include the timeframe in which the corrections will be completed and provide any documentation that will effectively assist us in evaluating whether the corrective actions have been made and the adequacy of such. If you are unable to complete the corrective actions within fifteen (15) working days, identify the reason for the delay and the time within which you will complete the corrections.
Your written response should be sent to the U.S. Food and Drug Administration, Attn: Lakisha N. Morton, Compliance Officer, at the address noted in the letterhead. If you have questions, please contact Mrs. Morton at 404-253-1285 or write her at the noted address.
John R. Gridley