− | <ref>https://www.casewatch.net/board/med/lentz/complaint_3.shtml Florida Revokes Medical License of John L. Lentz, M.D. Stephen Barrett, M.D.<br><br>The Florida Medical Board has revoked the medical license of John Luther Lenz, M.D. after concluding that he had improperly diagnosed and unjustifiably treated seven patients with Lyme disease, Bartonellosis (a bacterial infection), and/or Babesiosis (a parasitic infection) and failed to keep adequate records. The charges were made in three administrative complaints. The first and second complaints each involved one patient, and the third complaint (shown below) involved five patients. In July 2016, following hearings, an administrative law judge concluded that Lentz was guilty of "repeated malpractice" and recommended that the Board revoke Lentz's license and impose a $30,000 fine plus costs. In November 2016, the Board accepted this recommendation.<br><br>Lentz practiced in Destin, Florida. In 2009, when he was medical director for Aluwe LLC, the FDA ordered the company to stop representing that its flagship product, Germ Slayer, was effective against Lyme disease, Borellia, malaria, and many other diseases. During Lentz's association with Aluwe, the company's Web site represented him as one of the world's leading authorities on Lyme disease. The company is no longer active.<br><br>Attorney Jann Bellamy has posted a brilliant discussion of the problem of so-called "Lyme literate" doctors who improperly diagnose patients with "chronic Lyme disease" and administer prolonged antibiotic treatment.</ref> | + | <ref>https://www.casewatch.net/board/med/lentz/complaint_3.shtml Florida Revokes Medical License of John L. Lentz, M.D. Stephen Barrett, M.D.<br><br>The Florida Medical Board has revoked the medical license of John Luther Lenz, M.D. after concluding that he had improperly diagnosed and unjustifiably treated seven patients with Lyme disease, Bartonellosis (a bacterial infection), and/or Babesiosis (a parasitic infection) and failed to keep adequate records. The charges were made in three administrative complaints. The first and second complaints each involved one patient, and the third complaint (shown below) involved five patients. In July 2016, following hearings, an administrative law judge concluded that Lentz was guilty of "repeated malpractice" and recommended that the Board revoke Lentz's license and impose a $30,000 fine plus costs. In November 2016, the Board accepted this recommendation.<br><br>Lentz practiced in Destin, Florida. In 2009, when he was medical director for Aluwe LLC, the FDA ordered the company to stop representing that its flagship product, Germ Slayer, was effective against Lyme disease, Borellia, malaria, and many other diseases. During Lentz's association with Aluwe, the company's Web site represented him as one of the world's leading authorities on Lyme disease. The company is no longer active.<br><br>Attorney Jann Bellamy has posted a brilliant discussion of the problem of so-called "Lyme literate" doctors who improperly diagnose patients with "chronic Lyme disease" and administer prolonged antibiotic treatment.</ref><br> |
− | <ref>https://www.casewatch.net/fdawarning/prod/2009/aluwe.shtml WARNING LETTER<br>Dear Mr. Hann:<br><br>This letter is in reference to your firm's manufacture, distribution and labeling of your product, Germ Slayer, identified during our inspection conducted on August 17-18, 2009, at your facility located at 6909 Magda Drive, Maple Grove, Minnesota. Additionally, we conducted a review of your websites, www.aluwe.com and www.GermSlayer.net. These actions were conducted to determine your firm's compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and its implementing regulations contained within Title 21 of the Code of Federal Regulations, Part 101 (21 CFR 101). As a result of the inspection and our review of your websites, we have found that your Germ Slayer product is promoted with claims that cause it to be an unapproved new drug within the meaning of section 505 of the Act (21 U.S.C. § 355). Additionally, even if your product were not a new drug, it would be misbranded as a dietary supplement within the meaning of sections 403(e)(1) and 403(s)(2)(B) of the Act [21 U.S.C. §§ 343(e)(1) and 343(s)(2)(B)]. You may find the Act and CFR through links on our website, www.fda.gov.<br><br>New Drug<br><br>Your firm manufactures and promotes Germ Slayer, which is labeled with claims on your website that cause it to be a new drug. Examples of some of the claims observed on your website include: [...]</ref> | + | <ref>https://www.casewatch.net/fdawarning/prod/2009/aluwe.shtml WARNING LETTER November 30, 2009<br>Dear Mr. Hann:<br><br>This letter is in reference to your firm's manufacture, distribution and labeling of your product, Germ Slayer, identified during our inspection conducted on August 17-18, 2009, at your facility located at 6909 Magda Drive, Maple Grove, Minnesota. Additionally, we conducted a review of your websites, www.aluwe.com and www.GermSlayer.net. These actions were conducted to determine your firm's compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and its implementing regulations contained within Title 21 of the Code of Federal Regulations, Part 101 (21 CFR 101). As a result of the inspection and our review of your websites, we have found that your Germ Slayer product is promoted with claims that cause it to be an unapproved new drug within the meaning of section 505 of the Act (21 U.S.C. § 355). Additionally, even if your product were not a new drug, it would be misbranded as a dietary supplement within the meaning of sections 403(e)(1) and 403(s)(2)(B) of the Act [21 U.S.C. §§ 343(e)(1) and 343(s)(2)(B)]. You may find the Act and CFR through links on our website, www.fda.gov.<br><br>New Drug<br><br>Your firm manufactures and promotes Germ Slayer, which is labeled with claims on your website that cause it to be a new drug. Examples of some of the claims observed on your website include: [...]</ref> |