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Latest FDA Warning Letters

08/01/2006

Today FDA posted its latest batch of Warning Letters. They can be accessed in Adobe PDF format by clicking on the link following each letter.

Betterthanair, LLC Evergreen, CO (7/21). Unapproved new drugs, misbranded. Statements on the firmís Web site include intended uses such as for AIDS, lung cancer, chronic mountain sickness, and high altitude sickness, etc. The products are misbranded because they are marketed without a prescription and they lack the statement "Rx only." The inclusion of the disclaimer, "Not for medical and prescription use," on the productsí labels does not remove the product from the prescription dispensing requirement, etc. (BetterThanAir oxygen enriched products); FDCA 502(f)(1), 503(b)(2), 502(o), 510(i)(1) and (j)(1) (DEN-06-21)

http://www.fda.gov/foi/warning_letters/g5951d.pdf

Boulder Natural Labs, LLC Boulder, CO (7/19). Unapproved new drug, misbranded: Claims in the labeling of AvaFlu that the product prevents and treats avian flu and other forms of influenza cause the product to be a drug, etc. (AvaFlu); FDCA 505, 502(a) (DEN-06-20)

http://www.fda.gov/foi/warning_letters/g5950d.pdf

Cardiac Science Corp. Bothel, WA (7/11). Inspected 4/11-26. QSR deviations, adulterated: The company failed to adequately validate a process that cannot be fully verified by subsequent inspection and test. For example, a printed circuit board assembly was not validated after changes were made and the Rev C board was released for production on 4/23/04. Cardiac Science also failed to maintain procedures for implementing corrective and preventive actions. The company did not address the issue of quality requirements on incoming product, when the vendor is shipping a significant quantity of boards that are not passing inspection, etc. (automated external defibrillators); FDCA 501(h), 21CFR 820.90(a) and (b)(2), 820.75(a), 820.100(a), 820.50 (MIN 06-27)

http://www.fda.gov/foi/warning_letters/g5947d.pdf

DFWX Wolfe City, TX (7/19). Unapproved new drugs, misbranded: Claims on the firmís Web site state that 35% food grade hydrogen peroxide is intended to prevent and even combat cancer, can treat conditions traditionally treated with antibiotics without the serious toxicity, including influenza, the common cold, Epstein-Bar virus, and gangrene. Firm makes false and misleading promotional statements. For example, it states: "Because it is produced in the human body, it is undeniably safe," etc. (hydrogen peroxide); FDCA 505(a), 502(a) (2006-DAL-WL-26)

http://www.fda.gov/foi/warning_letters/g5949d.pdf

FRAD 35, Inc. Clyde, TX (7/19). Unapproved new drug, misbranded: Company marketed 35% food grade hydrogen peroxide for conditions such as allergic reactions, influenza symptoms, and acute viral infections. The product is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the productís labeling. FDCA 505(a), 502(j). 502(f)(1) (2006-DAL-WL-27)

http://www.fda.gov/foi/warning_letters/g5948d.pdf

Elizabeth L. Hohmann, MD Boston, MA (7/10). Inspected 2/28-3/10. Clinical studies violations: Company failed to submit an IND to FDA. In Study 1 the investigator administered an unapproved attenuated strain of Listeria vaccine to at least 20 subjects between 10/14/99 and 12/01 and continued the study until 8/2/04 without submitting an IND application to FDA. The investigator also obtained informed consent from some subjects using consent form versions for Study 1 that were not approved by the IRB. The investigator did not maintain adequate and accurate case histories, etc. (vaccine study); 21CFR 312.20(a), 312.60, 312.62(b), 312.66 (CBER-06-007)

http://www.fda.gov/foi/warning_letters/g5945d.pdf

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