CDER CYBER LETTERS.The following untitled letters were e-mailed by the Office of Compliance at the Center for Drugs to firms that sell dietary supplements and/or prescription drugs from Web sites. Copies of these letters are available from our RECORD-RETRIEVE Service for $7 plus retrieval.10172W Ken Adachi, Costa Mesa, CA, Jan. 11 (CDER-OC). FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. stated that Adachi's claim that his colloidal silver product could "resolve or mitigate more than 650 types of infections" was violative because such claims made the product a new drug for which he held no new drug application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ). DSHEA DSHEA Dietary Supplement Health and Education Act of 1994 (US legislation) , Web 10173W Scott Brown, Phoenix, AZ, Jan. 11 (CDER-OC). The agency wrote that Brown's claim that his ionic silver mineral water was for treatment of anthrax and cerebrospinal meningitis cerebrospinal meningitis n. See meningococcal meningitis. was a violation because such claims made the product a new drug. DSHEA, Web 10174W Gary Farley, Sterling Heights, MI, Jan. 11 (CDER-OC). FDA stated that Farley's claim that a colloidal silver product could "disable the enzymes that aid unhealthy intruders" and treat cuts and irritations "anywhere in the body" required an NDA. DSHEA, Web 10175W Tim Harvey, Aurora, CO, Jan. 8 (CDER-OC). The letter cited Harvey's Web site for claiming that colloidal silver had antibiotic properties "that help to destroy bacteria, fungi and viruses" made the product a new drug for which he had filed no NDA. DSHEA, Web 10176W Jeanette Meester, Omaha, NE, Jan. 8 (CDER-OC). Meester's Web site was cited for claims that colloidal silver was "an effective antimicrobial" that constituted a "second immune system." DSHEA, Web 10177W Roschach Martin, Mulgrave, Victoria, Australia, Jan. 30 (CDER-OC). The agency wrote up Martin for his Web site's testimonial that a colloidal silver product was "convinced it contains the cure for AIDS (acquired immune deficiency syndrome Acquired immune deficiency syndrome (AIDS) A viral disease of humans caused by the human immunodeficiency virus (HIV), which attacks and compromises the body's immune system. ). DSHEA, Web 10178W Synergy Systems, San Rafael, CA, Jan. 8 (CDER-OC). Violative claims for colloidal silver included "potent antimicrobial and antifungal agent," and claims for Synergy Growth factors included "improves cell growth and regeneration." DSHEA, Web 10179W Eva Taub, Miami, FL, Jan. 11 (CDER-OC). Taub's Web site was cited for claiming that colloidal silver would "perform miracles in healing and drying out skin lesions." DSHEA, Web 10180W Y2K See Y2K problem and Y2K compliant. Y2K - Year 2000 Natural Herbs, Glennville, GA, Jan. 8 (CDER-OC). The company's claims for colloidal silver included treatment of ringworm ringworm or tinea (tĭn`ēə), superficial eruption of the skin caused by a fungus, chiefly Microsporum, Trichophyton, or Epidermophyton. and claims for DHEA DHEA dehydroepiandrosterone. DHEA abbr. dehydroepiandrosterone DHEA, n dehydroepiandrosterone, a hormone precursor, exists naturally in yams. (dehydroepiandrosterone) included increased life expectancy." DSHEA, Web |
|
||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion