We saw a lot of action on natural health issues over the past year, including some big wins. Here’s where we stand on some of the top issues where ANH works to protect your access to natural health.
Senator Durbin’s Push for FDA Supplement Registration
Senator Dick Durbin (D-IL) pushed hard this year for additional regulations to increase costs and decrease access to vitamins and supplements. In addition to introducing his stand-alone bill, the Dietary Supplement Listing Act of 2022, he also attempted to attach this proposal to several larger must pass legislative packages, but we successfully fought back every time. Senator Durbin’s bill never moved, and he wasn’t able to attach it to the final FDA user fee reauthorization package or to the end of year federal funding package. We know he’ll continue trying to move his legislation forward in 2023, so we will continue our efforts to protect access to supplements.
Major Victory for Supplement Science
In 2014, the FDA started applying drug rules to research being conducted on nutrients. This caused university research on nutrients to slow or even stop in some cases, depriving us of knowledge that could be deployed to support our health. ANH-USA pressured the FDA with grassroots activism, submitted a Citizen’s Petition asking for these very changes, and even met in-person with agency staff to discuss the urgent need for reform. After years of sustained pressure from ANH, the FDA has finally relented; the agency has issued a proposed rule that will allow more research to be done on nutrients without triggering drug rules.
FDA Expected to Release Major Supplement Regulations
The FDA has stated that it plans to release an updated draft or final version of the “new dietary ingredient” (NDI) guidance by the end of this year. It is no exaggeration to say that this is the most dangerous threat to supplements we’ve seen in decades, because it seeks to impose a drug-like pre-approval system on supplements that would eliminate an estimated 41,700 products from the market. We continue to vehemently oppose the guidance as currently written and demand that substantial changes are made before the final version is released.
More State Legislation Attacking Supplements
California, Massachusetts, Missouri, New Jersey, New York, and Rhode Island all saw bills introduced this year to restrict access to dietary supplements. We’ve seen bills like this in the past, but it is a growing issue. In California and New York, the bills reached the governors’ desks but both were vetoed. Given how close these bills are coming to being signed into law, this is certainly another avenue to restrict supplement access where we must remain vigilant.
Big Pharma Gaining Monopolies Over Supplement Ingredients
A back-channel exists at the FDA that allows supplements that the FDA considers “new” (those that came to the market after 1994) to be turned into drugs while the supplement form is banned forever. As a result of this loophole, CBD, NAC, NMN and other supplements ingredients are at risk of elimination from the food and supplement marketplace.
Four years after the FDA first argued that CBD was no longer permitted in supplements, the ingredient remains in legal limbo. This year, ANH supported bills in the House and the Senate to permit CBD in supplements, but they unfortunately did not move forward. Meanwhile, the FDA continues to send warning letters to companies selling CBD in food and beverages. The Farm Bill will need to be renewed in 2023 and may provide an opportunity for progress on this issue.
NAC faces a similar challenge, but this year we edged closer to a major victory in protecting access to this critical antioxidant supplement. In August, the FDA finalized an enforcement discretion saying that if it didn’t find safety issues with NAC, the Agency may issue an exemption to permit NAC in dietary supplements.
As we celebrated this positive news on NAC, however, FDA announced that another vital anti-aging supplement, NMN, is now also at risk. After approving a new dietary ingredient notification to permit NMN in a dietary supplement in May, the FDA then reversed course in November and stated that NMN could no longer be sold in dietary supplements because it was already being investigated for use in a drug. This blow yet again demonstrates the need for a greater change to the law that permits pharmaceutical companies to create monopolies on natural ingredients that have been sold in the marketplace for years. ANH is advocating for greater transparency in the investigational new drug process, in addition to a time limit on these Big Pharma monopolies to give consumers greater access to these natural ingredients. ANH is also advocating for a bill to specifically allow NMN to be sold as a supplement.
Imminent Threat to Homeopathy
The FDA recently completed its updated policy regarding how it will regulate homeopathic medicines. The FDA has essentially declared all homeopathic products in the U.S. illegal. In theory, the FDA will turn a blind eye to many homeopathic products that it believes are being sold illegally but do not present serious safety issues. However, the axe is dangling above these products because the FDA could, if it decided to, take enforcement action against any homeopathic products it chooses because, in the agency’s view, all homeopathic drugs are currently being marketed illegally. In the world of the FDA, a product being marketed illegally is a regulatory distinction and separate from the question of whether consumers can still purchase the product. The FDA stated that it will focus its enforcement actions on injectable products, products with safety issues, and products intended for serious conditions or vulnerable populations. ANH is organizing with allies to mobilize grassroots opposition to this policy to protect homeopathic medicines from FDA attack.
A Win for Personalized Glutathione; Looming Threats for Thyroid and Estriol
In a major win this year, the FDA’s advisory Pharmacy Compounding Advisory Committee (PCAC) listened to thousands of patients and consumers and voted against the FDA’s recommendation to ban compounded glutathione. While the PCAC’s recommendation does not ensure the FDA will agree to continue to permit compounded glutathione, it will be very difficult for the FDA to go against this PCAC recommendation. ANH submitted petitions from both consumers and health professionals to PCAC arguing for continued access to compounded glutathione. ANH was also instrumental in coordinating glutathione’s initial nomination to be included in the list of medicines that could be legally compounded, helping to put together a list of dozens of studies attesting to glutathione’s safety and as well as comments from health practitioners about glutathione’s many uses.
Despite this win, FDA is still actively attacking personalized compounded medications. In September, the FDA declared natural desiccated thyroid (NDT) to be a “biologic” and thus ineligible for pharmacy compounding. This personalized medication is critical for millions of Americans with thyroid disorders.
ANH also continues to fight the FDA as they march toward a ban of compounded bioidentical hormones such as estriol, which are vital for women managing menopause and for helping with other hormone imbalances.
In 2022, ANH advocated for a slew of reforms that would make cosmetics safer by, among other things, banning toxic chemicals from being included in these products. Measures aimed at improving the safety of cosmetics were included in the end-of-year spending bill expected to be passed by Congress. These measures fall short of banning dangerous chemicals from cosmetics, but represent a step in the right direction and that Congress is listening to ANH-USA member advocacy on this topic.
Some Progress Against Environmental Toxins
In September, the EPA announced a proposal to designate perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), two of the most widely used PFAS chemicals, as hazardous substances. Being listed as hazardous substances by the EPA makes it easier for the government to compel polluters to foot the bill for cleaning up contaminated sites. Medical studies link PFAS to an array of health problems, including reduced immune response, liver damage and endocrine disruption. The EPA action is a positive step but falls short of what is really needed, which is designating PFAS as an entire class as hazardous substances.
Court Victory on GMO Labeling
When the sham GMO labeling law was passed by Congress, consumers were outraged because the “labeling” law allowed companies to hide the contents of their food. Instead of plain language labeling, it allowed companies to include scannable QR codes on packaging that consumers would need to scan with a smartphone to discern if the food contained GMO ingredients. Now, a federal court has ruled that a QR code alone is not an adequate GMO disclosure, and will need to be accompanied by a disclosure option accessible to all Americans. Significant problems remain, but this is an important victory.
Protecting Vaccination Choices
ANH advocated on hundreds of bills in 2022. Specific to vaccination choice, ANH helped kill 21 bills in nine states that threatened vaccine choice and helped pass 16 bills in ten states that promoted vaccine choice.
California Censors Doctors
One of the hardest legislative losses this year was the passage of CA AB 2098, a law that makes it easier for the state medical board to target doctors who disseminate “misinformation” related to COVID, and sadly, other states have introduced similar legislation. Censorship and restrictions on free speech continues to be a problem we are fighting at all levels as we work to protect your access to beneficial scientific information.
Looking Forward to 2023
As this list shows, we’ve accomplished a lot, but there’s a lot more work to be done. Senator Durbin isn’t finished trying to regulate therapeutic supplement doses out of existence. The FDA continues to brandish the axe over compounded medicines like estriol, so we need to remain vigilant in our defense of these critical medicines. We will fight for legislation that will clarify that homeopathic medicines are not required to go through new drug approval, thus protecting consumer access to homeopathic medicines. We will fight for changes that prevent drug companies from turning natural substances like CBD, NAC, and NMN into drugs. We need to fight back against the ubiquitous contamination of our world with PFAS chemicals by urging a reluctant EPA to stop protecting industry and start protecting consumers. We need to build on the momentum of the GMO labeling court victory to fight for better GMO labeling disclosures so consumers can make informed choices about the foods they eat.
Looking ahead, ANH is also deeply concerned about the development of GMO soil microbes and their potential to cause an ecological catastrophe, as we’ve seen with other experiments in genetic engineering. Look out in 2023 for coverage of this topic and other topics related to the interconnection between regenerative agriculture and human health.
There is also a critical need to stand up to the censorship that has swept over this country. Censorship has long been a problem for proponents of natural health, who often are targets of so-called “skeptics” and “quackbusters,” but the COVID pandemic sent this tendency into overdrive, providing censors with a pretext to silence those who challenge medical orthodoxies as threats to public health. Social media companies and state and federal governments have gotten in on the action. If doctors aren’t allowed to discuss alternatives to the mainstream medical approach, not only are the legal requirements of informed consent not being satisfied, but integrative doctors’ ability to treat individual patients will suffer. We will continue to fight against and expose censorship of natural health information.
We have a lot of plans for 2023, but we’re also aware of the need to be nimble in responding to the curveballs thrown by the FDA and other federal agencies that threaten our ability to stay healthy, naturally.
We appreciate your support and advocacy and look forward to continuing our work in 2023.