Inspections, Compliance, Enforcement, and Criminal Investigations
Ancient Formulas Inc. 2/9/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Kansas City District|
11630 W. 80th Street
Lenexa, Kansas 66214
February 9, 2011
RETURN RECEIPT REQUESTED
Gohlam (Mark) A. Aghakhani
President and Owner
Ancient Formulas Inc.
638 W. 33 rd St. North
Wichita, KS 67204-4536
Dear Mr. Aghakhani:
This letter follows the October 18 through October 21, 2010 inspection of your facility located at 638 W. 33 rd St. North by a representative of the U.S. Food and Drug Administration (FDA). This letter is in reference to your firm's marketing and distribution of various products that are promoted for conditions that causes them to be drugs under section 201(g)(1) of the federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)]. The therapeutic claims on your product labels or labeling establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. Labeling is not limited to the immediate product containers but includes all promotional literature which you distribute in connection with your products. The marketing of these products with these claims violates the Act. You may find the Act and FDA's regulations through links on FDA's Internet home page at http://www.fda.gov.
Examples of some of the claims observed in your labels and labeling, including pamphlets provided to the consumer upon distribution, include:
• "[D]esigned for indications such as acute and chronic infections' inflammation, ... anemia."
• "Ligusticum Wallichii, when combined with Astragalus and Ligusticum [ingredients in your product] ... demonstrated ... anti-bacterial, anti-fungal and anti-inflammatory properties."
• "[I]nhibit the recurrence of malignancy... prevent adverse toxicities such as leucopenia, thrombocytopenia, and anemia of many anti-cancer drugs."
• "These herbs are traditionally recommended ... as a supplement for hyperglycemia and glucosuria."
• "Gymnema Sylvestre [an ingredient in your product] is a wild-crafted herb traditionally used for its anti-diabetic properties."
• "Bitter Melon or Momordica Charantria fruit extract [ingredients in your product] ... was shown to help in managing type II diabetes ... "
• "[T]reatment with this herb [holy basil; an ingredient in your product] caused over 17% reduction in fasting blood glucose level, and over 7% reduction in post-prandial level."
• The name on the label of this product ("CHOLESTOLESS") suggests that it will lower cholesterol levels.
• "Guggulipid [an ingredient in your product] is an anti inflammatory saponin and lowers the blood cholesterol."
H.P. #1 (Hyper-ten-sion)
• The statement of identity on the product label and brochure "B.P. #1 (Hyper-ten-sion)" suggests that the product's intended use is for the treatment of hypertension.
H.P. #2 (Hyper-ten-sion)
• The statement of identity on the product label, "H.P. #2™ HYPER-TEN-SION Herbal Dietary Supplement" suggests that the product's intended use is for the treatment of hypertension.
RE. #3 (Breathe Eaze)
• "The Chinese herb Lonicera (an ingredient in your product] ... help[s] people with the side effects of the common cold virus. It ... has anti bacterial effects that are effective in upper respiratory tract infections."
• "Eyebright herb ... reduces inflammation and is used internally for sinusitis, allergic rhinitis, hayfever and upper respiratory tract infections."
• "The buchu leaves [an ingredient in your product] ... has healing ... effects on the genitorurinary system. It can be especially useful in painful and burning urination."
• "Garlic [an ingredient in your product] has also been shown to have anti microbial activity against many disease causing organisms, including those associated with urinary tract infections."
• The statement of identity on the product brochure "PROST-AID" appears to suggest that the product's intended use is for the treatment of prostate disorders.
• [T]hese ingredients [in your product] have been scientifically proven to shrink a swollen prostate. "
• "[M]ay help ... Blepharitis (inflammation of the outer edges of the eyelids that causes redness, itching and burning), blurred vision, color blindness ... "
• The statement of identity on the product brochure, "ARTHRO-CARE" appears to suggest that the product's intended use is for the treatment of arthritis.
• "Arthro-Care has been designed for treating and preventing Osteoarthritis and Rheumatoid arthritis or any other joint conditions."
• "There are many studies on Cotostrum [an ingredient in your product] in the treatment of Rheumatoid and Osteoarthritis."
• "[M]SM [an ingredient in your product] has been investigated for its use in arthritis and other complications of joint inflammation."
• "[C]hondroitin Sulfate [an ingredient in your product] has a slow but consistently beneficial effect on arthritis which seems to extend after treatment ends."
• "Monolaurin [an ingredient in your product] removed over 99.9% or [sic] all measurable infectivity of the 14 viruses by disintegrating the virus envelope."
• "In addition to its antiviral effects, monolaurin [an ingredient in your product] ... has been shown to have antibacterial activity against Staphylococcus aureus, Streptococcus agalactiae, Groups A, F&G Streptococci, Chlamydia, H.Pylori and against yeast and fungi as well, including Candida and ringworm."
• "Asparagus in [sic] known to soothe inflammation ... "
• "Gamma schizandra, deoxyschizandrin and schizandra are the active components [of Schisandra herb, an ingredient in your product] that help relieve emotional and physical depression and
reverse depression .... "
• "The other major biological property of turmeric and Curcuminoids [ingredients in your product] is their anti-inflammatory activity ... "
• "The ... role of turmeric extract and Curcuminoids [ingredients in your product] as anticarcinogens (preventing the development of cancer) ... "
• "Curcuminoids [an ingredient in your product] have also been shown to exhibit anti-microbial properties."
• "Extracts from turmeric [an ingredient in your product] as well as ... the Curcuminoids [an ingredient in your product), were found to inhibit the growth of numerous bacteria, fungi ... "
These therapeutic claims establish that the products are drugs under section 201(g)(1) of the Act, because they are intended for use in the cure, mitigation, treatment, or prevention of disease. Your products are also "new drugs" under section 201 (p) of the Act, because they are not generally recognized as safe and effective for the above referenced conditions. 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.
Misbranded Dietary Supplements
Even if your "DYABET" product was not an unapproved new and misbranded drug, it would still be a misbranded dietary supplement under section 403 of the Act [21 U.S.C § 343] in that the labeling for this product does not comply with the food labeling requirements in Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101). Your products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C § 343(i)(2)] because they contain ingredients that are not declared on the label, as required by 21 CFR 101.4, For example, the "DYABET Herbal Dietary Supplement (90 Capsules)" product is contained in a capsule, but the capsule ingredients (e. g., gelatin) are not listed. Furthermore, your product is misbranded under section 403(q)(5)(F) of the Act [21 U.S.C § 343(q)(5)(F)] in that the presentation of nutrition information on the labeling for your product does not comply with 21 CFR 101.36. Specifically, your "DYABET" product did not present nutrition information in a panel tilled "Supplement Facts," as is required under 21 CFR 101.36(e)(1).
This letter is not intended as an all-inclusive review of all labeling and products your firm may market and/or distribute. It is your responsibility to ensure that all products marketed or distributed by your firm are in compliance with the Act and its implementing regulations, We request that you take prompt action to correct these violations. Failure to promptly correct these violations may result in enforcement action being initiated by the Food and Drug Administration without further notice. The Federal Food, Drug, and Cosmetic Act provides for the seizure of illegal products (Section 304) and for injunction against the manufacturers and distributors of illegal products (Section 302) [21 U.S.C §§ 334 and 332].
During the inspection, the investigators noted several deviations from the dietary supplement Good Manufacturing Practice requirements at 21 CFR Part 111. You addressed these deviations in your response to the FDA-483, dated November 2, 2010. We will confirm that you have implemented the corrections during the next inspection of your firm.
Please respond in writing within fifteen (15) working days of the receipt of this letter, as to the specific steps you will take, or have taken, to correct the violations identified in this letter and any other violations of the Act, and to assure that similar violations do not occur. Your response should include an explanation of each step being taken to achieve and maintain compliance with the regulations. Include copies of any available documentation demonstrating that corrections have been made. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be implemented.
Please direct your response to Amy E. Devine, Compliance Officer, Food and Drug Administration, at the above letterhead address.
John W. Thorsky
Kansas City District