Since its inception, the Alliance for Natural Health USA has waged many successful battles to protect alternative health options . Throughout our history we have played an important role in filing precedent-setting lawsuits and passing significant legislation that directly benefit the natural health community:
We were instrumental in passing the Dietary Supplement Health Education Act of 1994 (DSHEA), widely considered to be the single most important piece of legislation for the industry. This law guarantees access to safe, effective, and affordable dietary supplements.
We led the effort to establish the National Center for Complementary and Alternative Medicine in in 1998. It’s part of the National Institutes of Health, undertakes research, does training, and disseminates data to the public and professionals. NCCAM still isn’t where we want it to be, but we hope to get it there.
To date, we have filed nine precedent-setting lawsuits against the FDA, which have established qualified health claims for saw palmetto, omega-3 fatty acids, fiber, vitamin E, vitamin B, and selenium.
Our first suit was the landmark case of Pearson v. Shalala—and because we won, there is now widespread public knowledge about the importance of consuming enough folate during pregnancy to prevent neural tube defects. Prior to this legal victory, supplement manufacturers were not permitted to let consumers know about this important nutrient relationship, and many consumers were in the dark. “Qualified health claims” characterize the relationship between a substance and its ability to reduce the risk of a disease or health-related condition. They are permitted in relation to foods and supplements—a precedent established by the landmark decision of Pearson v. Shalala.
We sued the FDA (and won!) for violating the First Amendment as well as the Administrative Procedure Act by not allowing the dissemination of truthful, scientific information on dietary supplement labels as part of their 2011 Draft Guidance on New Dietary Ingredients.
In addition, we have achieved some remarkable victories, both in Congress and in court:
Congress has been wrestling with legislation about compounded medications, which many consumers rely upon—compounding can provide just the right dose, delivery system, and combination of medicines, which benefit the patient far more than premade medications. The FDA created some provisions that sparked a dramatic outcry from ANH-USA’s grassroots activists. We have won significant victories to protect compounded medications and continue to fight to maintain the integrity of this important medical treatment option.
Ensured that a USP (The United States Pharmacopeia and The National Formulary (USP–NF) is a book of public pharmacopeial standards. It contains standards for (chemical and biological drug substances, dosage forms, and compounded preparations), excipients, medical devices, and dietary supplements) monograph will protect compounded ingredients from FDA intrusion. Since important ingredients like bioidentical estriol have a USP monograph, this change will ensure that estriol is protected from the FDA and remains available for the millions of women who rely on it.
Protected the right of compounders to make non-standardized dosages of drugs. Since people come in all shapes, sizes, with unique biochemistries, it is important to allow doctors to customize dosages for individual needs.
Removed a Senate bill provision that compounders needed to perform random controlled trials (RCTs) in order to meet a “safety and efficacy” standard. This was a backdoor approach to banning compounded medicines, because no one could afford to pay for those trials of non-patentable or off-patent drugs, and RCTs, in any case, are inappropriate for medicine that is—by definition—individualized, as compounding is.
Removed the requirement from the Senate bill that doctors must substantiate the need for a compounded prescription. This requirement would create an untenable burden on physicians and would impede the use of compounded medicines.
Removed the impossible-to-measure standard that physician office use of compounded drugs can only represent 10% of compounding pharmacy sales, as well as a provision requiring physician reporting within a few days.
Pressured the FDA to reverse their initial stance and allow compounding pharmacies to continue providing 17P (a progesterone medicine that can help prevent preterm birth) to pregnant women, despite the efforts of KV Pharmaceutical to ban it as a competitor to their drug Makena.
The US Food and Drug Administration is revising the list of drug products that are to be withdrawn or removed from the market for reasons of safety or effectiveness. ANH-USA submitted formal comment to the agency, protesting its proposed elimination of public participation from the process—compounded medications are of great value to consumers, and many are being unfairly branded as unsafe or ineffective. We may pursue legal action if FDA doesn’t take our concerns into consideration.
The FDA is taking nominations its list of bulk drug substances that may be compounded. We submitted two nominations as well as formal comments.
In our comments regarding the FDA’s proposed list for outsourcing compounding facilities, we are arguing against the new standards FDA established for a facility to be included on the list. This opens the door for us to take legal action following further action by FDA.