b'Legal Arguments Destroy the FDAs Position on NACCRNslettermakesanumberof powerful arguments, joined in by many others, that undercut the FDAs regulato-ry position on NAC (and to which I have added):The supposed drug-approval date of 1963 for NAC is suspiciously hand-written and appears to be unsupport-ed by any other evidence of such ear-ly approval or even the identity of the person who wrote the date.The drug supposedly approved for marketing in 1963 was an inhalation drugandnottobeadministered orally,which,accordingtoSection 201(ff)(3)(B)(i), should be treated as a different article than an orally tak- new drugs, which incentive is miss- of Nutrition and Food Labelingthat en dietary supplement. ing if the same drug and supplementissued the warning letters to the sup-werealreadyonthemarketpriorplement companies making the hang-The first approval for an NAC-con- tothisDSHEAprovisionevenover marketing claims does not have tainingdrugadministeredorallyexisting. the authority to decide whether or not alone did not occur until 2016, wellany ingredient is permissible or not.after the date of first use of NAC as aFDAssuddenchangetoitslong-supplement. standingpolicyofpermittingTheFDAOfficeofNutritionand dietarysupplementscontainingFoodLabelingdidnotfollowthe The first approval for an NAC-con- NAC to be marketed is arbitrary andprocedural requirements of the en-taining drug administered both bycapricioussincetheFDAhasmul- abling statute that would allow the inhalationandorallyoccurredintiple times referred to NAC as a di- FDA to issue a legally binding regu-1982, but that single drug was dis- etary supplement. latory order on the sale of NAC-con-continued and was not replaced bytaining supplements.any similar drug until August 1994.Closely related to the arbitrary and Regardless,bothdrugsareoncecapriciousdefense,theequitableTherefore, although there can be no againdifferentarticlesanddis- doctrineoflachesforeclosesanyguaranteesthesedayswheregovern-continued drugs should not be usedpartywhohasunreasonablyde- mentagenciesthinkofthemselvesas as a pretext to prevent supplementslayed or otherwise shown a lack offree to act on whatever caprice or whim from going to market. diligence in pursuing a claim, all tostrikes their idle fancy, it is fairly safe the prejudice of the other party, fromtosaythattheincorrectobservations Section201(ff)(3)(B)(i)cannotbebringing any action against that oth- madeinhealth-claimwarningletters applied retroactively to any supple- er party on that claim. Here, the FDAby one outlier office of the FDA should mentmarketedbeforetheDietarydelayed for decades declaring NACnot stampede the industry into prema-SupplementHealthandEducationa drug only, while numerous com- turelyeliminatingtheirNACproduct Act (DSHEA) was passed and signedpaniesalreadyinvestedsignificantlines.AsNPAhascorrectlypointed intolawonOctober25,1994sincesums of money to bring NAC sup- out,therehasbeennofinalagency (a)Congressmadenoprovisionplements to market and keep themaction taken on NAC sales. So, why are forretroactivityand(b)theentirethere. so many companies dashing for the exit purposeofthatSectionwastoin- doors? Stand and fight. And win.centivize drug companies to developThe specific FDA officethe Office2021 Scott C. Tips8 H ealtHF reedomN ews /s ummer2021'