b'ditives. Congress intended the law to createbitantly expensive proof of safety and effi- pharmaceutical- and food-grade standards, a reasonable regulatory framework to ben- cacy for all NDIs, which is clearly contraryan appraisal of itself as an industry, and efit the more than 110 million Americansto the intent of Congress when it originallycanbeproudofitsheritageandaccom-who were consuming dietary supplementspassed DSHEA. Unquestionably, the FDA isplishments in providing dramatic econom-at the time. The main goal was to protectonce again using burdensome regulationsic benefits to society at large resulting from access to, and information about, dietaryas a means to protect pharmaceutical drugsthe use of its products. As an example, the supplements. from any natural competition in the mar- family-owned NOW Foods dietary-supple-However, to gain passage by the phar- ketplace. And, thus, the mere mention thatment manufacturer received not only the maceutical-industry-controlled Senators, aa nutrient, for example, may help protectBest Manufacturing Award for the indus-compromise was made to require that anyagainst influenza can result in jail time. try but has also received Illinois States Best and every label for every dietary-supple- Now, one must be well aware of the dif- Manufacturer Award.ment bottle making any nutritional claimference between the two terms pharma- Sadly, however, the supplement indus-bear the following disclaimer, This prod- ceutical and nutraceutical. Pharmaceu- try is being slowly bought up by large cor-uct is not intended to diagnose, treat, curetical drugs do harm and any benefit fromporate interests and highly effective prod-or prevent any disease. As we all know, in- them needs to be closely monitored withucts once offered are no longer available. tention is everything and so is prevention!any number of bad side effects warrantingUnfortunately,withdirect-to-consumer To state, for example, that Vitamin C doesimmediatecessation.Theyarepharma- advertising of pharmaceutical drugs being not prevent scurvy, or that niacin does notceuticals. The word pharma comes fromlegally allowed in the USA (one of only two prevent Pellagra, is an absurdity; and manyGreek,meaningpoison.Ceuticaliscountries that allow it), media advertising other deficiency diseases exist that are easi- Greek for medicine. is being bought up with the result that any ly reversed through vitamin therapy. How- Vitamins,aminoacids,enzymes,andcontent providing nutritional education is ever,thesenutrientscannotbepatentedmineralsareallnutraceuticals.Nutrabeing reduced in magazines, newspapers, and therefore enormous profits are reducedisderivedfromnutritionalmedicines.and television (and now even on the inter-to moderate ones. These provide benefits and rarely, if ever,net), and what content remains is closely In fact, DSHEA actually became a nooseandonlyunderspecialconditions,maymonitored for any health statements made.as one governmental agency, the FDA, se- they cause any harm, such as getting tooMovingforward,anotherremarkable verely tried to expand the definition of themuchiron,forexample,ortoomuchofadvanceoverthepastfourdecadeswas term disease to include pregnancy, men- a single nutrient that is not properly bal- theincreasingnumberofdigestiveand struation,andothernaturalhealthstatesanced, or by not following their proper use. proteolyticenzymesmadeavailableby or conditions, such as menopause. WhereFinally, the nail in the coffin is that themanufacturers, with their enormous bene-thereisnorelevantdiscussioninpublicgovernmentheavily lobbied by the phar- fits in digestion and reduc-aboutnutritionalsupplementsandtheirmaceutical industrywants every formulainginflammation.There benefits, there is no education, and whereand every nutrient sold by every companywas also the emergence of there is no education, there is no prevention.to follow its costly, drug-like approval pro- healthy food oils, especial-What became even worse was that thecedure, which will result in the destructionlyeveningprimroseoil, FDA successfully pushed for a requirementof the supplement industry with the elimi- coconut oil, and topical oils to provide for pre-market notification to thenation of most companies and leaving onlysuchasTamanuoil,and FDA by anyone introducing a new nutrienta few large, rich producers or manufactur- Emu oil, each providing a ingredient into the marketplace, calling anyers. That will greatly diminish the creativebroad range of benefits.such post-October 15, 1994 nutrients Newenterprise and reduce the introduction ofTheproductsaddress-Dietary Ingredients or NDIs. At the timenew successful nutritional products.inghormonalhealthrep-that hardly seemed onerous; but now moreThis would be a great detriment to theresentyetanothergreatcategorybreak-thanthirtyyearshavepassed,andthehealth of the country where it is alreadythrough.Whenhormonesareoutof number of NDIs has greatly exceeded thewell established that hundreds of millionsbalancemuchharmandsufferingoccur. numberofgrandfathered-iningredients.of dollars each year are saved by the useOne by one the health industry provided The FDA has finally come forward (ironi- ofnutritionalsupplementation.Thedi- melatonin, DHEA, pregnenolone, and the cally at the insistence of the supplement in- etary-supplementindustryisuniqueinmost popular productnatural progester-dustry itself) and issued a draft NDI Guid- many ways. It demonstrates a tremendousonenot to be confused in any way with ance that has horrified the industry. Onceeffort to create and maintain the safety andsynthetic progesterone. Introduced to the madefinal,theFDAdraftGuidanceonhealth of the purchaser. Most manufactur- industry by Ray Peat and popularized by NDIs would treat and burden the produc- ers are pharmaceutically licensed and allDr. John Lee with follow-ups by Clara Felix, tion, distribution, and sale of dietary sup- must,anddo,meetstrictmanufacturingit proved to be the answer to many womens plements with virtually the same require- requirements. It is a relatively new indus- menopausal and hormonal health issues in ments as those for pharmaceutical drugs!try that through the years has succeededa safe and effective way.This includes the requirement of an exor- in developing and maintaining the highestAnothercategoryofremarkable H ealtHF reedomN ews /w iNter2020 15'