1994, Dietary Supplement Health and Education Act (DSHEA): To reign in the FDA’s power over dietary supplements, Congress passed sweeping legislation that allows supplements to be regulated like food instead of like drugs. It allowed for the historical use of an herb or supplement to support its designation as “generally regarded as safe and effective.” Specifically, no expensive and time-consuming proof of efficacy is needed for supplements, as is required for drugs. And in order to remove a supplement from the market, the FDA is required to prove its harmfulness, instead of supplement manufacturers being required to prove its safety.
1996: The FDA loses an 11-year battle against Life Extension Foundation (LEF). For over a decade the FDA tried to shut down LEF for providing information to consumers about safe and effective nutritional supplements. At one point, they used Gestapo-like tactics to break into LEF’s offices (smashing windows and knocking down doors!) to seize their supplements and newsletters at gunpoint, threatened scientists with imprisonment for accepting LEF research grants, and indicted the organization’s founders on multiple criminal counts that could have resulted in $7 million in fines and 84 years in jail. After three years of fighting those charges in federal court, the FDA offered to reduce the charges to misdemeanors if they pled guilty to a lesser charge. The refused to plead guilty to any criminal behavior, and continued their court battle. The U.S. Attorney’s Office ultimately decided that the FDA could not win in court, so they dismissed all criminal indictments, effectively shutting down the FDA’s dogged pursuit of LEF.
1999, Pearson v. Shalala (also called Pearson I): Durk Pearson and Sandy Shaw sued to allow four specific health claims for natural supplements: antioxidants reduce various cancers, fiber reduces colorectal cancer, omega-3 oils reduce coronary heart disease, and folic acid as a dietary supplement is more effective against neural tube defects than folic acid in foods. The court found their the FDA’s method of evaluating health claims was purely subjective. They ruled that the FDA violated the First Amendment by suppressing the dissemination of factual information about dietary supplements. The most significant aspect of this case is that it was won on Constitutional grounds. In a 3-0 Appellate Court ruling, the FDA was told that it had to abide by the free speech protections guaranteed by the First Amendment to the United States Constitution. The FDA was forced to allow health claims for supplements, with the disclaimer, “These statements have not been evaluated by the Food and Drug Administration.” Prior to this court ruling, any implication of benefit for a natural product would allow the FDA to confiscate all of the product from store shelves and sue the manufacturer for “misbranding” the supplement.
2000: Congress passes a bill, which was signed into law by President Bill Clinton, that would allow Americans to import FDA-approved drugs from certain listed countries that had effective safeguards in place. The list of approved countries included Canada and most of Europe, but not Mexico. This was a major victory for American consumers, who could take advantage of lower drug prices overseas, and a major defeat for big drug companies, who could no longer charge punitive prices to American purchasers. The bill provided for a $25 million/year appropriation to the FDA to implement the drug importation provisions. In a move that boggles the mind, FDA Secretary Donna Shalala refused the $25 million/year appropriation and did not implement the program. Its estimated that the program would have saved American consumers billions of dollars on their drug purchases each year. There is no stronger evidence that the FDA is working for big drug companies and against the American consumer.
2000: The U.S. General Accounting Office (GAO) stopped the FDA from implementing a proposed ban on ephedra supplements. They questioned the veracity of the FDA’s adverse event report (AER) data and criticized the “sophomoric” research they used in formulating the ruling.
2001, Pearson v. Shalala (also called Pearson II): Durk Pearson, Sandy Shaw, Julian Whitaker, MD, et al. focused on the FDA’s refusal to comply with the court-ordered folic acid claim. The court again ruled against the FDA, saying that the public interest is best served by allowing information about the ability of folic acid to reduce birth defects, and such information should reach as wide an audience as possible. It is especially egregious that the FDA’s refusal to comply with the previous court order caused an untold number of birth defects.
2002, Whitaker v. Thompson: Julian Whitaker, MD, Durk Pearson, Sandy Shaw, Pure Encapsulations, Inc., et. al. sued the FDA for suppressing a specific claim that was the subject of the 1999 Pearson I ruling (“Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancers.”). They won an unprecedented third legal victory that has eviscerated the FDA’s power to censor truthful scientific information. In response to this series of defeats, the FDA announced a new initiative called “Better Health Information for Consumers,” aimed at making more information available about natural supplements. It appeared that the FDA had finally gotten the message, but in reality, they simply redirected their war against supplements to a different front: banning supplements they don’t like by declaring them “adulterated.”
2005, Neutraceutical v. Crawford: Neutraceutical Corp. and Solaray, Inc., its subsidiary, filed suit against the FDA to overturn its 2004 ban of ephedra supplements. The judge ruled that the FDA used an inappropriate “risk/benefit” test and did not prove that the supplement is actually harmful, as required by DSHEA, before banning the supplement. The court also found that the FDA’s “scientific research,” based upon injections of a prescription drug instead of upon oral ingestion of the supplement itself, was unsound. They reminded the FDA that foods do not require a proof of benefit. The ruling overturned the FDA’s ban and prohibited them from stopping the sale of low-dose ephedra supplements.