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FDA Set to Ban Your Supplements ... The FDA has issued a proposed mandate that represents the greatest threat to dietary supplements since 1994. Back in the early 1990s, consumers were so alarmed by FDA bullying that they staged a massive revolt. The result was that Congress passed a law prohibiting the FDA from banning popular nutrients (as the agency had threatened to do). There was, however, a loophole in the 1994 law. The FDA was given authority to regulate ingredients introduced after October 15, 1994. It has been 17 years, but the FDA just issued draconian proposals as to how it intends to regulate what it now calls "new dietary ingredients." If implemented, some of the most effective nutrients you are taking will be removed from the market. This includes many fish oil formulas and natural plant extracts. – Mercola's Blog
Dominant Social Theme: Raw milk and fish oil can kill you. It is much better to eat "heart healthy" potato chips.
Free-Market Analysis: Dr. Joseph Mercola is out with a "red alert" posted on his website reporting on new regulations from the Food and Drug Administration that may reduce or eliminate people's access to such food additives as fish oil.
Dr. Mercola is a leading authority on non-pharmaceutical nutrition and he has even posted a letter on his website that people can copy, personalize and email to their congressional representatives on Capitol Hill regarding these new regs. The letter makes the point that Congress actually passed a law (DSHEA) back in 1994 to try to prevent the FDA from doing exactly what its bureaucrats intend to do now.
According to Dr. Mercola, the FDA wants to require manufacturers to conduct "outrageously expensive studies using absurdly high doses, in some situations multiplied by a safety factor up to 2,000-times the recommended dosage on a per product basis." Here's some more:
The FDA defines dietary supplements as being "new" if they were introduced after October 15, 1994. That means that even certain nutrients that have been safely used over the course of three decades will be subject to the FDA's oppressive policies that mandate costly animal testing. According to the new guidelines, the FDA believes that "new dietary supplements" must be regulated similarly to synthetic food preservatives.
The FDA guidelines have modeled the outrageous safety thresholds after those in place for food additives. This appears to be in direct violation of DSHEA, the law enacted in 1994 to protect consumer access to dietary supplements, which classifies dietary supplements as foods, not food additives. The FDA proposes that new dietary supplement ingredients should adhere to aggressive safety margins, which are typically reserved for chemical compounds known to be dangerous in all but the most miniscule concentrations.
Since food additives or preservatives such as aspartame, monosodium glutamate, and sodium nitrate are known to cause cancer or other severe health problems, the FDA has implemented safety guidelines which limit allowable concentrations of these food additives to levels that are supposed to be physiologically inert. The fact that the FDA is trying to impose the same limits upon dietary supplements seems to be arbitrary and completely unfounded.
What concerns Dr. Mercola, especially, is that new guidelines would declare as "unsafe" even nutrients that are obviously harmless and have been proven so in numerous human clinical studies. Each manufacturer of certain fish oils, he reports, would have to conduct a one-year study where animals would have to consume the human equivalent of 240,000 milligrams each day of fish oil. The guidelines, he writes, will thus make it impossible for certain omega-3 supplements to be sold.
There is the issue of cost. No manufacturer, he observes, will be able to afford these studies as the margin for profit in supplements is not nearly as high as that of pharmaceutical drugs. New players will therefore enter the market with re-priced supplements, and prices will go far higher. Then there is the issue of the danger itself. Pharmaceutical drugs are statistically far more dangerous than supplements. He writes:
According to the 2001 report of the American Association of Poison Control Centers (AAPCC), of the substances implicated in fatal poisonings in 2001, 84.6 percent were pharmaceutical drugs, with analgesics being implicated as the primary cause of death in 32 percent of fatalities or 341 deaths. This compares with 0.8 percent for all dietary supplements combined, even including substances such as dinitrophenol, a dangerous (and illegal) substance banned in 1938, as well as the central nervous system stimulant Ma Huang (Ephedra).
For Dr. Mercola the damage is clear. Many companies that provide food supplements will be forced out of business and those that remain or come back into the market will have to offer the same products at significantly higher prices.
Consumer choice is inevitably whittled down. Instead of being able to use a nutritional supplement no longer on the market, many people will be forced to turn to "side-effect laden" prescription drugs. In fact, according to Dr. Mercola, the drug industry will receive another benefit because people will get sicker sooner without supplements, further increasing the sale of drugs to treat various degenerative diseases that might have been kept in check with proper nutrition.
The FDA has been much in the news recently for helping to prosecute Amish farmers who produce raw, unradiated milk. (Some have even gone to jail.) Dr. Mercola and others have made the point that while people die of cancer from smoking and liver disease from drinking alcohol, there are few if any modern instances where people's health has been undermined from drinking whole milk.
For Dr. Mercola as for many others, the FDA and regulators like it around the world are not supporting the best interests of consumers but are actively working with major pharmaceutical companies to reduce or eliminate consumer choice.
There are plenty of alternative therapies that do not involve drugs, but the FDA and similar regulators are regularly removing choices from the market. It SEEMS as if the pharmaceutical model is winning the war in the marketplace, but actually when one looks more closely the pharmaceutical model is actually failing and is being propped up by Western regulatory authorities.
Why should this be so? It is well known that pharmaceuticals, with their tremendous profits and legally sustainable patents, are an industry that has benefited considerably from an alliance with the Anglosphere power elite – which may own a considerable interest in the larger companies.
In fact, restrictive FDA regs are only a minor part of the attack on nutritional supplements and traditional health care (acupuncture, herbal healing, etc.). The much-criticized Codex Alimentarius promoted by world health care organizations is a fundamental source of barriers to traditional treatment. Here's how Dr. Mercola describes it:
The "Codex Alimentarius" itself is a compilation of food standards, codes of practice and guidelines that specify all requirements related to foods, whether processed, semi-processed, genetically engineered, or raw. Their purpose is to protect consumers' health, ensure fair business practices within the food trade, and eliminate international food trade barriers by standardizing food quality.
This sounds all well and good, but there are major problems with the strategies they use to "keep you safe." There are many problems with Codex, many of which are not immediately recognizable unless you have the proper perspective. But one of the most bizarre and potentially dangerous issues is their Vitamin and Mineral Guideline, finalized on July 4, 2005, which classifies nutrients as toxins.
Yes. This is what you end up with when you use Risk Assessment to assess the safety of nutrients. Risk Assessment is a branch of Toxicology, also known as the science of toxins. In a sane world, it is used to assess how much of a toxic substance you can safely consume without noticing any physical effects or problems. As soon as there is a biological effect, you have hit the upper, maximum limit for that substance.
Codex Alimentarius has, slowly but surely, been shimmying into position to mandate the universal maximum "safe" level of every vitamin, mineral, supplement and herb that may legally be manufactured, used or sold -- with "safe" being a level that has no physical effect ... The final goal is global "harmonization" with Codex' insanely restrictive rules and flawed ideas about nutrition.
There are countervailing forces, however. As we can see from the recent GOP presidential debates, there is a good deal more awareness of the abuses of the pharmaceutical industry in the 21st Century than the 20th. For instance, during a recent debate, Rep. Michele Bachmann, (R-Minnesota), alleged that Texas Governor and presidential hopeful Rick Perry had come under the influence of pharmaceutical dollars.
She claimed that an executive order issued by the governor in 2007 that mandated teenage girls in Texas be inoculated against a virus that may cause cervical cancer was motivated by pharmaceutical donations. Perry claimed that the donations only amounted to US$5,000, but various recent investigations show that Perry's ties with the pharmaceutical industry are deep and wide. He is still fighting off the controversy.
Here at DB, we've often reported on the furor that has resulted from linking vaccines to autism and even interviewed Dr. Andrew Wakefield who worked on research that led to some of these speculations. The pharmaceutical industry has launched a vicious attack on Dr. Wakefield that lasted for years and resulted in him being disbarred in England. You can see our interview here: Dr. Andrew Wakefield Exclusive Interview.
Questions about vaccines persist and have grown significantly larger. It is perhaps impossible in this era of the Internet Reformation for the pharmaceutical industry to hide behind legislation and regulation. The controversy over vaccines continue to grow.
Why? Because professional medical people like Dr. Wakefield and Dr. Mercola can present their message effectively via the Internet. Thus they can circumvent the elaborately constructed pastiche of mainstream media and scientific and academic journals that the power elite previously depended upon to effectively silence those who opposed the pharmaceutical model of medicine.
We would argue this is a trend that is gathering strength and that people's health may actually improve in the 21st Century as the hold of the pharmaceutical model over health care information is eroded by the alternative media. It is another area where power elite mainstream memes may gradually be seen to be in retreat.