The claim: FDA approval ‘means nothing’ because the agency approved cigarettes, alcohol and other unhealthy products
Cigarettes. Alcohol. Cheetos. Red Bull. Coronavirus vaccine?
After the U.S. Food and Drug Administration gave its official stamp of approval to the Pfizer-BioNTech COVID-19 shot, some social media users tried to dismiss it by pointing to other products the agency has purportedly approved.
“In honor of Pfizer’s rushed jabby-jab approval … let’s name all the other ways the FDA has legalized sickening and killing people,” Adam Ringham, a Facebook user with more than 19,000 followers, wrote in an Aug. 23 post.
The post includes a photo of two lists: one with “FDA approved” products and one with products that are “not FDA approved.” Among the products in the former column are cigarettes, alcohol and Red Bull, while the latter column includes “every and all vitamins,” shampoo and raw milk.
“FDA approval means nothing,” reads text at the top of the image, which accumulated more than 11,000 shares within two days.
Prior to the FDA’s full approval, anti-vaccine advocates falsely cited Pfizer’s emergency use authorization as evidence that its coronavirus vaccine was “experimental” or unsafe. Now, posts with tens of thousands of interactions on Facebook are making a misleading comparison between the vaccine and other products regulated by the FDA.
“It makes no sense,” Robert Field, a law professor and health care regulation expert at Drexel University, said of the Facebook post. “The approval process for drugs, including biologics … is completely different from that of foods, cosmetics, herbal supplements and most of the other items they mentioned here.”
FDA doesn’t ‘approve’ every product it regulates
The Facebook post misconstrues what it means for a product to be “FDA-approved.”
In response to USA TODAY’s request for evidence, Ringham sent a video on Rumble, a YouTube alternative that’s popular among conservatives. The clip shows an Idaho doctor who has previously made false and misleading claims about the safety of COVID-19 vaccines. The video does not back up the claims in the Facebook post.
The FDA is charged with ensuring food, drugs, medical devices, cosmetics and other products are safe for American consumers. As Ringham’s post references, part of that mandate includes regulating tobacco products.
To legally sell or distribute a new tobacco product, manufacturers must receive a written order from the FDA. But that order doesn’t mean the product is safe or “approved” – just that the manufacturer has complied with the law.
“There’s no such thing as a safe tobacco product, so FDA’s safe and effective standard for evaluating medical products is not appropriate for tobacco products,” the agency says on its website. “Instead, FDA regulates tobacco products based on a public health standard that considers the product’s risks to the population as a whole.”
Alcohol, meanwhile, is regulated by the Treasury Department’s Alcohol and Tobacco Tax and Trade Bureau. And other products listed in the Facebook post don’t go through the same approval process as vaccines.
Take foods like Red Bull and Twinkies, for example.
“The FDA rarely approves a food,” R. Alta Charo, a professor emerita of law and bioethics at the University of Wisconsin-Madison, told USA TODAY. “Foods go on the market without any prior screening by the FDA if they are generally recognized as safe.”
That includes dietary supplements and vitamins, which the FDA regulates as foods. As long as a manufacturer can, if challenged, cite evidence that its product is safe, the FDA only intervenes if there’s a problem.
“Basically, we have a risk-based regulatory approach in the U.S.,” said Charo, who previously served as a policy adviser at the FDA.
Exceptions include food and color additives, for which the FDA does have premarket approval. Still, the approval process for drugs, medical devices and biologics – which include vaccines – is more stringent than FDA regulations for any other product, experts told USA TODAY.
“Drugs and biologics go through a rigorous clinical testing process,” Field said. “That is not true for Twinkies, Cheetos or even cigarettes and alcohol.”
Pfizer vaccine is safe, effective
Clinical trials involving tens of thousands of participants, as well as data from the nationwide vaccine rollout, show Pfizer’s coronavirus vaccine is safe. The FDA’s full approval means the vaccine can be distributed even when there’s not a public health emergency.
In December, the FDA approved Pfizer’s coronavirus vaccine for emergency use, allowing Americans to get the shot because of the risk posed by the coronavirus pandemic. That decision was based on data from clinical trials, which included nearly 37,000 participants.
Trial results indicated the vaccine was 95% effective at preventing symptomatic infection. Since then, more than 92 million Americans have received the Pfizer vaccine in full. Side effects are rare, and while breakthrough infections are possible, state data analyzed by the Kaiser Family Foundation indicate the majority of new COVID-19 cases are among unvaccinated people.
The application included additional safety and efficacy data confirming the results of Pfizer’s initial clinical trials. That data, derived from a study involving 44,000 participants followed over several months, indicated the vaccine was 91% effective in preventing COVID-19.
“The public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” Dr. Janet Woodcock, acting commissioner of the FDA, said in a statement.
Full FDA approval of the Pfizer vaccine means the shot’s benefits outweigh its risks even when there’s not a public health emergency, Charo said. It also allows companies to market the vaccine.
“This is as thoroughly vetted as any drug or biologic on the market,” Field said. “If you’re willing to take an antibiotic or a statin or a blood pressure drug, you should be willing to take the Pfizer vaccine.”
Our rating: Partly false
Based on our research, we rate PARTLY FALSE the claim that FDA approval “means nothing” because the agency approved cigarettes, alcohol and other unhealthy products. While the FDA regulates foods, cosmetics and tobacco products, the agency generally does not “approve” them before they’re sold on the market. The FDA does not regulate alcohol at all. Drugs, medical devices and biologics – including Pfizer’s coronavirus vaccine – undergo a rigorous clinical testing process, while most other products regulated by the FDA do not.
Our fact-check sources:
- U.S. Food and Drug Administration, accessed Aug. 24, Is It Really ‘FDA Approved?’
- Robert Field, Aug. 24, Phone interview with USA TODAY
- USA TODAY, Aug. 23, Pfizer-BioNTech COVID-19 vaccine becomes first to win FDA’s full approval, paving way for boosters, mandates
- USA TODAY, Aug. 5, Fact check: 6 of the most persistent misconceptions about COVID-19 vaccines
- R. Alta Charo, Aug. 24, Phone interview with USA TODAY
- U.S. Food and Drug Administration, accessed Aug. 24, What does FDA regulate?
- U.S. Alcohol and Tobacco Tax and Trade Bureau, accessed Aug. 24, Beverage Alcohol – TTB Regulated Industry
- Eater, March 24, 2017, USDA vs. FDA: What’s the Difference?
- U.S. Department of Agriculture, accessed Aug. 24, Mission Areas
- U.S. Food and Drug Administration, Aug. 24, Dietary Supplements
- U.S. Food and Drug Administration, Dec. 10, 202, FDA Briefing Document: Pfizer-BioNTech COVID-19 Vaccine
- U.S. Food and Drug Administration, accessed Aug. 25, Emergency Use Authorization for Vaccines Explained
- USA TODAY, March 27, Comparing the COVID-19 vaccines
- Centers for Disease Control and Prevention, accessed Aug. 25, COVID Data Tracker: COVID-19 Vaccinations in the United States
- Centers for Disease Control and Prevention, accessed Aug. 25, Pfizer-BioNTech COVID-19 Vaccine Overview and Safety
- Kaiser Family Foundation, accessed Aug. 25, COVID-19 Vaccine Breakthrough Cases: Data from the States
- USA TODAY, Aug. 24, Breakthrough COVID-19 cases worrying you about getting vaccine? Experts say it shouldn’t.
- U.S. Food and Drug Administration, accessed Aug. 25, Comirnaty and Pfizer-BioNTech COVID-19 Vaccine
- USA TODAY, May 7, Pfizer-BioNTech seeks full FDA approval for COVID-19 vaccine
- U.S. Food and Drug Administration, Aug. 23, FDA Approves First COVID-19 Vaccine
- CrowdTangle, accessed Aug. 25
- Factcheck.org, April 19, Idaho Doctor Makes Baseless Claims About Safety of COVID-19 Vaccines
- Adam Ringham, Aug. 25, Facebook exchange with USA TODAY
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