b'The number of serious adverse drug events reported to the FDA betweenThe39thannualreportfromthe 1998 and 2005 more than doubled to 467,809, according to a report in theAmerican Association of Poison Control September 10th issue of the Archives of Internal Medicine. Thomas J. MooreCenters(APCC)showszerodeaths and his colleagues (at the Institute for SafeMedicationPractices,Plymouthfrom vitamins.Meeting,Pennsylvania)analyzedse-rious adverse drug events reported toand costly regulatory guidance? Supple-the FDA and found in addition to thements are already safer than water and number of cases reported in the Ad- aspirin, not even to mention heavily verse Event Reporting System (AERS),regulated drugs! More paperwork and the number of fatal adverse drug eventsmore money spent will not make our increased from 5,519 to 15,107 in thesupplements any safer than they already same time frame, which is a 2.7-fold in- are. Dietary-supplement products are al-crease. 8The overall relative increaseready subject to post-market inspection, was four times faster than the growthGMP standards, and other regulations. in total U.S. outpatient prescriptions,In a free market, consumer demand is which grew in the same period from 2.7the strongest authenticator. In the end, billion to 3.8 billion, the researchersthe market and consumers win.concluded. 9 Drugsraiseseriouscon- Lets be honest. The real reason be-cerns indeed; and, clearly, supplementshind the FDA using its Senate bagman anddrugsarenoteveninthesameDick Durbin to try to shove its manda-class. Nor should they ever be treatedtory dietary-supplement listing require-in the same way either. ment down our throats has nothing to Supplements Are Safe do with safety. Rather, it is intended to drive more supplements off the shelves, As I have been writing and saying forraise their prices beyond the reach of years, dietary supplements are excep- mostAmericans,andtobankruptor tionally safe. Statistically, a person isnumber is 86%.But lets just use thedriveoutofbusinessthesmallerdi-more likely to die from a bee sting or alower number. Should each of those peo- etary-supplement companies, thus de-lightning strike than he or she is fromple take only one single tablet daily, thatterring innovation and paving the way taking any dietary supplements. still makes over 220,000,000 individualfor the large pharmaceutical industrys AndrewSaulconfirmedthisview- doses per day, for a total of well over80use of many of the very same ingredi-point when he wrote earlier this year, asbillion doses annually. Since many per- ents, with now-skewed molecular struc-he has been doing for several consecutivesons take far more than just one singletures, to sell them as patented drugs at years now, that, The 39th annual reportvitamin tablet, actual consumption isa premium.from the American Association of Poi- considerably higher, and the safety ofThe FDA would further accomplish son Control Centers (APCC) showszerovitamin supplements is all the more re- this bymaking it a prohibited actto deaths from vitamins. Confirming datamarkable. 12 introduce into interstate commerce any is in Table 22B, pp. 1613-1615, at theWhat About Supplementsproduct marketed as a dietary supple-very end of the lengthy report publishedment that does not meet the definition inClinical Toxicology. 10 . . . Further- Needs Fixing?of a dietary supplement under Section more, there were no fatalities from min- Asthelatehealthresearcherand201(ff). 13This is the administrative ex-eral supplements. Two fatalities fromwriter Bill Sardi repeatedly asked ofcuse by which FDA bureaucrats could Iron and Iron Salts were clearly statedFDAs constant attempts to foist morereject ingredients like CBD (cannabi-asnotbeing due to supplemental iron. 11 regulations upon supplements, Whatdiol)andNAC(N-acetyl-L-cysteine) Saul noted that at least two-thirdsare we trying to fix? What is actuallyfrom being marketed as dietary supple-of the U.S. population takes daily nu- broken? There is nothing that needsments, regardless of their long history tritional supplements: A Harris Pollfixing.Arewereallyimprovingtheof safe use.indicated that for American adults, thesafety of supplements through complex 8 H ealtHF reedomN ews / s ummer2023'