Welcome to the FDA Truth Project
Stop Misinformation by Reporting FDA Information Quality Act Violations
Stop FDA Misinformation
Report violations by the FDA of the Information Quality Act
FDA is violating the IQA with misinformation on
Dietary Supplements
Botanical Supplements
Homeopathic Remedies
Pain Relief Therapies
Submit your Official IQA complaint form to report a violation by the FDA
Let the US Congress know about the FDA’s persistent violations of the Information Quality Act
Submit Reports of FDA Information Quality Act Violations on Dietary Supplements, Botanical Products, Homeopathic Remedies, and Pain Relief Therapies.
Share with us what you’ve found and we’ll submit it to Congress as an example of FDA Information Quality Act (IQA) Violations.
You will receive a downloadable copy of the complaint that will be submitted to Congress
Don't be Misled by FDA Misinformation About Natural Products!
Dietary Supplements, Botanical Products, Homeopathic Remedies, and Pain Relief Therapies and under constant attack with often unfounded statements and misleading or outright inaccurate information from the FDA.
Pain Relief Therapies The FDA has admitted failure in communicating health information. This is the moment to show them to correct their errors!
The growing spread of rumors, misinformation and deliberately false data about science, medicine, and the FDA, is putting patients and consumers at significant health risk.
FDA Commissioner Califf has stated that combating misinformation is a chief goal at the agency as it emerges from the Covid-19 pandemic, and commissioned the Reagan Udall Foundation to research the issues.
The report identifies how the FDA has actually spread confusion and has been alarmingly poor at public communication.
“It is important for the American public to trust the FDA, its regulatory process, and its decisions. If they do not, the public cannot be expected to take the appropriate steps based on the FDA’s work to protect and enhance their own health, the health of their families, and the health of the nation. Improving understanding of FDA-regulated products first requires trust.”
From Reagan Udall Foundation Strategies for Improving Public Understanding of FDA-Regulated Products
Watch what even the FDA is saying about the dangers of misinformation
Examples of FDA Misinformation on Dietary Supplements
FDA claims on CBD:
The FDA has consistently claimed there is no safe level of CBD for human consumption. As early as 2017, the WHO Expert Committee on Drug Dependence (ECDD) concluded that, in its pure state, cannabidiol does not appear to have abuse potential or cause harm. CBD is generally well tolerated with a good safety profile. Reported adverse effects may be as a result of drug-drug interactions between CBD and patients’ existing medications.
FDA claims on NAC:
In July 2020, the FDA issued a flurry of warning letters to several companies marketing NAC as a hangover remedy, stating that these companies were making unlawful claims and illegally selling a pharmaceutical ingredient mislabeled as a supplement.
The warning letters contained language stating that: “FDA has concluded that NAC products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(i) of the Act [21 U.S.C. § 321(ff)(3)(B)(i)]. Under this provision, if an article (such as NAC) has been approved as a new drug under section 505 of the Act [21 U.S.C. § 355], then products containing that article are outside the definition of a dietary supplement, unless before such approval that article was marketed as a dietary supplement or as a food. NAC was approved as a new drug under section 505 of the Act [21 U.S.C. § 355] on September 14, 1963. FDA is not aware of any evidence that NAC was marketed as a dietary supplement or as a food prior to that date.”
In other words, the agency reverted to a position that NAC is a pharmaceutical ingredient based on a 60-year-old approval for an inhaled drug that was discontinued long ago.
FDA claims on Ivermectin:
On Aug. 21, 2021, the FDA tweeted a link to its webpage about ivermectin and COVID-19 — which was titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19” — and included this message: “You are not a horse. You are not a cow. Seriously, y’all. Stop it." The FDA explained that using drugs that haven’t been approved to treat a particular disease “can cause serious harm.” The agency described some of the potential consequences of unauthorized ivermectin use, specifically warning about the highly concentrated versions of the drug made for horses.
When challenged in court, the FDA claimed the statements simply communicated FDA’s recommendations regarding the use of ivermectin to prevent or treat COVID-19 and did not actually ban anyone from taking Ivermectin.
FDA claims on kratom:
On August 31st 2016 the DEA submitted a notice of “temporary placement of Mitragynine and 7-Hydroxy mitragynine in Schedule I” into the Federal Register;
Based on the FDA’s official position “The use of Kratom and associated products, which contains the main active alkaloid mitragynine and 7-Hydroxymitragine pose an imminent hazard to public safety”
Seven years later
December 1st, 2023
The Department of Justice requested the FDA state under oath their position on the danger of kratom as part of a DOJ case. However the FDA refused to do so and told the DOJ attorney
“The reason [FDA] gave us was that they have not yet made a determination regarding whether kratom is dangerous.”