b'P residentsn oteTHE FDA GOESAFTER HOMEOPATHIC EYE DROPSSince When Did the FDA Ever Get Anything Right?BY SCOTT C. TIPS, NHF PRESIDENTthat the companies eye drops consti-tuted an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and that no FDA-approved ap-plicationis in effect. 4The eight recipients of these FDA Warning Letters were Boiron Inc., CVS Health, DR Vitamin Solutions, Natu-ral Ophthalmics, Inc., OcluMed LLC, SimilasanAG,TRPCompany,Inc., andWalgreensBootsAlliance,Inc. Although the FDA alleged CGMP vi-olations in several of the letters, again there were no adverse events reported for any of these products.OnNovember13,2023,Kilitch Healthcare India Limited announced T hroughout the year 2023, theed four deaths and fourteen instancesavoluntaryrecalloftwenty-seven differenteye-dropsproductsthatit manufacturesforRiteAid,Leader, U.S. Food and Drug Admin- of eye loss after their use. 1 Target, Velocity, and other retail out-istration (FDA) has had over- Then, on August 22, 2023, the FDAlets.Theannouncementstatedthat the-counter(OTC)ophthal- releaseditswarningtoconsumersthese products are being recalled due mic products in its crosshairs. In Aprilnot to purchase and to immediatelyto potential safety concerns after FDA 2023,andafteran11-dayinspectionstopusingDr.BernesMSMDropsinvestigatorsfoundinsanitary[sic] that had begun in February, the FDA5% Solution and LightEyez MSM Eyeconditions. (emphasis added)found that the Global Pharma Health- DropsEye Repair due to bacterialWhile some homeopathic products carefacilityinIndiadidnotfollowcontamination, fungal contamination,arebeingsweptupinthegeneral properprotocoltopreventbacterialor both. 2 FDA multi-year dragnet of OTC eye contamination of its eye products. The The FDA, however, admitted thatdrops, I must agree with Alvin Lor-companyrecalleditsArtificialTearsthere were no adverse events associ- man, general counsel for the American LubricantEyeDrops,distributedbyated with the products. 3 Association of Homeopathic Pharma-EzriCareandDelsamPharma,evenNot yet finished, on September 11,cists (AAHP), when he wrote that, it before the FDAs inspection was com- 2023, the FDA then sent warning letterswould be premature to consider this pleted.Yet,theCentersforDiseaseto eight other companies, six of whichaction part of an FDA targeting home-Control and Prevention (CDC) report- were homeopathic companies, claimingopathy. 56 H ealtHF reedomN ews /w iNter2023'