Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm172563.htm
Timestamp: 2017-02-21 18:56:23
Document Index: 404827024

Matched Legal Cases: ['§ 321', '§ 321', '§ 331', '§ 352', '§ 201', '§ 331', '§ 352', '§ 332']

Bazaar Of India 7/7/09 Quick Links: Skip to main page content
Bazaar Of India 7/7/09
WARNING LETTER VIA FEDEX July 7, 2009 Kush Khanna, President & CEO
Dear Mr. Khanna: This letter concerns your finn's marketing of the products "Acnenil," "Cold Aid," "Sugar Fight," "Heart Plus," "Hingwastika," "Bakuchi," "Guggulu," "Brahmi," "Tagar," "Licorice," and "Triphala" on your website, www.bazaarofmdia.com. According to product labeling, these products are intended to cure, mitigate, treat, or prevent disease conditions or to affect the structure or function of the body. Statements documenting these intended uses include, but are not limited to, the following: Acnenil
• "Acnenil is a safe herbal preparation intended to' eliminate acne . . . [t]his rare Ayurvedic formula ... acts as an anti-bacterial and antiseptic ...."
Cold Aid • The name of this product suggests that the product is intended to mitigate or treat a cold. Sugar Fight • "If the pancreas does not metabolize and use sugar in the body properly" a diabetic disease can soon develop ... Set your body in balance and supplement a balanced diet with our new anti-diabetic formula, SUGAR FIGHT." Heart Plus • "[A]long ,with a balanced nutritional supplement are imperative for beating heart disease." • "The main affects [sic] of Heart Plus are to ... assist the body in avoiding or delaying the cardiovascular complications which occur with, age." Hingwastika • "Description: Good for ... pneumonia, and bronchitis of children."
Bakuchi • "Description: Helpful in managing ... leprosy, leucoderma, antifungal (sic) and antiprotozoal, ant tumor (sic)." Guggulu • "Effective for arthritis, bronchitis, diabetes, fevers ... ulcers." Brahmi • "It is used to ... decrease senility, stress and stress related diseases." • "[T]o treat fevers, inflammations, joint pain and a variety of skin problems such as eczema, psoriasis, boils and ulcers." Tagar (Valeriana wallichiil) • "Sedative, good for insomnia ...." Licorice • "As an anti-hepatotoxic licorice ... helpful in the' treatment of chronic hepatitis and cirrhosis....." • "This inhibits hepatocyte injury caused by carbon tetrachloride, benzene hexachloride and PCB." • "Glycyrrhizin inhibits (the growth of several DNA and RNA viruses, inactivating Herpes simplex virus particles irreversibly." • "It has a variety of uses in bronchial problems ... bronchitis ...." • "Liquorice (sic) is used in allopathic medicine as a treatment of peptic ulceration, a similar use to its herbal use in gastritis and ulcers."
Trifala • "[U]sed to treat ... chronic constipation ...." • "[R]educes serum cholesterol ... reduces high blood pressure ... has proven anti-inflammatory and anti-Viral properties ... hypertensive." • "It is used to treat ... ulcers, inflammation of the stomach, intestines, constipation ... infections ...."
• "[S]hown to have mild anti-bacterial properties ... anti-viral ...."
• "[T]reats asthma ... allergies ...."
• "Triphala can be prescribed singly or adjunctively whenever there, are symptom of inflammation ... infection, obesity ...." • "Triphala is safely taken for ... diseases such as tuberculosis, pneumonia and AIDS." • "Triphala is also widely taken for all eye disease including the treatment of conjunctivitis, progressive myopia, the early stage of glaucoma and cataracts." "Acnenil," '"'Cold Aid," "Sugar Fight," "Heart Plus," "Hingwastika " "Bakuchi," "Guggulu," "Braluni," "Tagar," "Licorice," and "Triphala" are drugs, as defined by the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. § 321(g), because they are intended to cure, mitigate, treat, or prevent disease or to affect the structure or function of the body of man or other animals. Moreover, these products are "new drugs," as defined by 201(p) of the Act [21 U.S.C. § 321(p)], because there is no evidence that they are generally recognized as safe and effective for their labeled uses." Under sections 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. Your sale of "Acnenil," "Cold Aid," "Sugar Fight," "Heart Plus," "Ringwastika," "Bakuchi," "Guggulu," "Brahmi," "Tagar," HLicorice," and "Triphala" without approved applications violates these provisions of the Act. " Furthermore because these 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 them safely for their intended uses. Thus, the labeling of" Sugar Fight," "Heart Plus," "Hingwastika," "Bakuchi," "Guggulu," "Brahmi," "Tagar," "Licorice," and "Triphala" fail to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1). Because they lack required approved applications, these drugs are not exempt from this requirement under 21 C.F.R. § 201.115. Therefore, the introduction or delivery for introduction into interstate commerce of these products violates section 301(a) and (d) of the Act, 21 U.S.C. §§ 331(a)and (d). The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. 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 your firm complies with all requirements of federal law and FDA regulations. In this regard, please note that products are misbranded under section 502(j) of the Act, 21 U.S.C. § 352(j), if they are dangerous to health when used in the dosage or manner; or with the frequency or duration prescribed, recommended, or suggested in the product's labeling.1
The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334]. You should take prompt action to correct the noted deviations and prevent their recurrence. Failure to do so may result in enforcement action without,further notice. Other federal agencies may take this Warning Letter into account when considering the award of contracts. Within fifteen working days of the receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the noted violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Additionally, if another firm manufactures the products identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the products is not the manufacturer, please include the name of your supplier in addition to the manufacturer: Address your reply to the U.S. Food and Drug Administration, San Francisco District Office, 1431 Harbor Bay Parkway, Alameda, CA 94502, Attention: Russell A. Campbell, Compliance Officer. 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. Sincerely, /S/
1 According to a study published in the August 27, 2008, issue of the Journal of the American Medical Association (JAMA), one-fifth of U.S.- manufactured and Indian-manufactured Ayurvedic products bought on the Internet contained detectable lead, mercury, or arsenic, and all metal-containing products exceeded one or more standards for acceptable daily metal intake. Among the products tested and found to contain lead, mercury, or arsenic were products from Bazaar of India. Saper RV, Phillips, RS, Sehgal, A, et al. Lead, Mercury, and Arsenic in US- and Indian-Manufactured Ayurvedic" Medicines Sold via the Internet. JAMA. 2008;300(8):915-923. -