Human drugs.

All American Pharmaceuticals and Natural Food Corp., billings, MT, Oct. 22 (Seattle).

During inspections on July 8 and Sept. 8, 9 and 15, and from a review of the firm's website and product labeling, FDA determined that several of the company's products were promoted for conditions that caused the products to be drugs.

Additionally, the agency said the company's dietary supplements were adulterated because the company did not notify FDA of new dietary ingredients and because its dietary supplements containing and rostenedione and/or other steroid prohormones (AndroBol, DiolBol, AndroMax and Androstenedione) had not been established as safe.

The company was cited also for having a dietary supplement with unsubstantiated structure/function claims; a product that failed to meet the definition of "dietary supplement"; and dietary supplements that had labeling deviations. Furthermore, the company did not meet exportation record-keeping requirements. Lab, NDA, Web; Doc. 13279W

Bradley Pharmaceuticals, Inc., Fairfield, NJ, Nov. 9 (DDMAC)

In a review of the promotional items for Pa-mine (methscopolamine bromide) 2.5-mg tablets and Pamine Forte 5-mg tablets, and the company's website, the agency determined that Bradley used effectiveness claims that were unsubstantiated; omitted all risk in-formation; misrepresented the safety of Pamine; and had failed to submit the website to DDMAC at the time it was first published. Furthermore, the sales aid, brochure and website suggested that Pamine and Pamine Forte are effective in treating gastrointestinal motility symptoms. Claims were also made indicating the products relieve symptoms of bloating, despite the fact that the Adverse Reactions section of the PI states that a "bloated feeling" has been associated with the use of the drugs. F-B; Doc. 13280W

Ferndale Labs, Inc., Ferndale, MI, Nov. 19 (Detroit)

Upon viewing promotional materials, labeling materials, package inserts and Ferndale Labs' website, FDA established the company's L.M.X.4 Topical Anesthetic Cream was being promoted for conditions that would cause it to be a new drug. Promotional materials for L.M.X.4 distributed to physicians' offices and hospitals made statements such as: "[Use] for pain associated with ... Needlesticks ... Venipuncture ... [and] Wart removal."

Furthermore, the product was not recognized as being safe; and the directions for use were not adequate for the intended uses, the agency said. The product is intended for topical over-the-counter (OTC) use as an anesthetic to temporarily relieve pain and itching due to minor cuts, scrapes, burns, skin irritations and insect bites. NDA, Web; Doc. 13281W

F. H. G. Corp., Sarasota, FL, Sept. 29 (Florida)

FDA inspections April 21 and 26, and July 23, indicated the firm had not notified the agency of any of its so-called "prohormone" products-Cinnulin PF, Gamma Oryzanol, Chitosan, 5-Methyl-7-Methoxyisoflavone, and Grape and Seed Extract--which were being promoted on the company's website for conditions that caused the products to be drugs.

According to the warning letter, the products were also misbranded because they failed to bear adequate directions for use.

Additionally, FDA said F.H.G. was holding a shipment of "4-Androstenedione" capsules with documentation establishing the product as a dietary supplement. However, the agency pointed out that it is not aware of androstenedione being considered an article used for food in a form in which the food has not been chemically altered; nor is it aware of evidence of safety data on androstenedione or evidence that androstenedione was lawfully marketed as a dietary ingredient in the U.S.

The agency acknowledged receipt of a letter from F.H.G., but said that it "does not alleviate our concerns with regard to the inspectional findings, in that it does not provide any information about permanent corrective actions to your firm's operations, if any, that you have implemented." NDA, Web; Doc. 13282W

MCR American Pharmaceuticals, Inc., Brooksville, FL (Florida).

In reviewing marketing and distribution mate-rials, FDA determined that MCR American did not obtain an approved NDA for its drug product Allfen, which had been reformulated. Specifically, "Allfen Tablets 1000 mg" is single-ingredient, guaifenesin extended-release product. The agency pointed out that the OTC monograph system does not include provi-sions for the extended-release dosage form of guaifenesin. Regulations specify that extended-release drug products are new drugs and require an approved application for marketing. NDA; Doc. 13283W

Tao of Herbs, Inc., Chicago, Oct. 22 (CFSAN).

FDA stated that Tao of Herbs' website re-garding its products--Now Phase-2 500 mg, Now Chitosan with Chromium and Irwin Naturals Maximum Strength Phase 2 Carb Blocker--contained un-substantiated therapeutic claims, thus deeming the supplements as drugs. Unsubstantiated claims included: "Now Phase-2, is an all-natural bean extract that inhibits alpha-amylase activity, thereby preventing the breakdown of dietary starches into glucose, allowing carbohydrate from starch to pass through the system unchanged"; and "[Chitosan] binds to negatively charged fats during digestion and reduces their absorption." Web; Doc. 13284W