More Evidence the FDA Works for Pfizer as FDA Asks Pfizer to Submit Cancer Drug for Expanded Approval with Zero New Trials

As the alternative media is distracted by the unfounded claim that Pfizer is using gain of function technology to develop new variants of COVID for future vaccines, Pfizer is quietly working together with the FDA to build their portfolio of drugs to make up for the loss of income due to decreasing numbers of people willing to continue getting injected with COVID shots. The evidence that Pfizer controls the FDA continues to mount. We previously reported how Pfizer virtually came out of nowhere to secure the first FDA authorization for experimental COVID shots in 2020, when the two drug companies that had received the most funding and attention to become the first ones to obtain the FDA nod for a new COVID "vaccine" had been Moderna, with their close links to Anthony Fauci and the NIH, and Astrazenca with its close links to Bill Gates. Pfizer's contract with Operation Warp Speed to receive funding for COVID-19 vaccines was different than the other pharmaceutical companies, because it was conditioned on them gaining FDA approval, and it did not include intellectual property rights for the U.S. government. It appears that this opened the door for them to grant an exclusive deal with Israel in exchange for data on how the experimental shots affected people in Israel, effectively making Israel and its citizens lab rats. And a year before Pfizer became a late entry in the contest to get the first FDA authorization for a COVID shot, Dr. Scott Gottlieb joined the Board of Directors for Pfizer in June of 2019, just two months after he finished his term as Commissioner of the FDA under President Trump. This week, Pfizer reported that they expect the sale of their COVID-19 shots and their antiviral Paxlovid to dramatically decrease here in 2023. But what surprised people in the pharmaceutical industry the most about Pfizer's forecast for 2023, was that in a "mysterious" FDA approval that was not reported in the media at the end of 2022, Pfizer received expanded use approval for their breast cancer drug Ibrance, and reportedly, the FDA is the one who approached them to expand the use of this drug! Is there any doubt anymore about who controls the FDA? Pfizer is the largest criminal organization in the world, and they would not be able to continue earning huge profits without their control of the FDA.

White House Extends COVID Public Health Emergency Status to Get More People Vaccinated with Deadly New Boosters

The tyrannical decree to declare COVID-19 as a "Public Health Emergency" that ushered in unprecedented measures to ignore the Constitution of the United States and to lock everyone down and eventually start injecting Americans with experimental shots that have now resulted in massive deaths and injuries, which was first declared by President Donald Trump almost 3 years ago on January 31, 2020, was just extended by the Biden Administration this week. For those who have eyes to see and ears to hear discerning the truth over the propaganda, it is obvious that this tyrannical decree was extended on behalf of Pfizer and Moderna, to continue justifying emergency use authorizations for experimental injections that otherwise would be illegal. This has always been the primary goal of the COVID-19 emergency measures started by Donald Trump in 2020 and his massive federal funding of Operation Warp Speed, which resulted in the addition of $TRILLIONS into the U.S. economy, bailing out Wall Street and the Central Bankers in the process. In order to justify this extension of the "Public Health Emergency," the State Department's medical authority talking heads had to lie to the American public, by stating that the current flavor of COVID-19 circulating around could only be stopped by the newly authorized COVID-19 "vaccines" produced by Moderna and Pfizer. White House COVID-19 Response Coordinator Ashish Jha, FDA Commissioner Robert Califf, and CDC Director Rochelle Walensky, are now complicit in criminal intent to commit mass murder in the United States. The FDA, CDC, and White House could not have authorized these new versions of the experimental COVID-19 shots without extending the "Public Health Emergency" status which overrides laws and Constitutional protections that prohibit drug companies from injecting experimental products into the bodies of American adults and children.

Pfizer Continues to Use Babies and Children as Lab Rats to Develop More COVID-19 Vaccines – Petitions FDA for New EUA Booster for 5 to 11 Year Olds

Pfizer and BioNTech announced today that they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a 10-µg booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age. They will also be making a submission to the European Medicines Agency (EMA) in the coming days. The Press Release today also reported that they have begun Phase 1/2/3 studies on babies and young children aged 6 months through 11 years of age to test "the safety, tolerability, and immunogenicity of different doses and dosing regimens of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 11 years of age." The Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine was already authorized for adults over the age of 18 on August 31, 2022 without any human testing, so Pfizer is using babies and children as lab rats to conduct the first human tests on this new COVID-19 vaccine.

FDA Approves Killer COVID Drug for Babies

While we have focused more on the COVID-19 vaccines that have created more deaths and injuries than all other FDA-approved vaccines for the previous 30 years, the other killer COVID drug currently being administered to the public is Remdesivir, with the brandname of “VEKLURY.” This drug, which was originally developed for ebola but never approved because it was so dangerous, has a history of scandals and many thousands of deaths since it was given an EUA (emergency use authorization) by the FDA, and then in October of 2020 it was fully approved by the FDA as a treatment for adults with COVID-19. To get the original EUA by the FDA, they had to attack existing drugs in the market that were already being proven as safe and effective against COVID-19 symptoms, such Ivermectin and hydroxychloroquine. A reasonable estimate of deaths caused by this killer drug worldwide would number in the millions. In September of 2021, Attorney Thomas Renz released to the public statistics on Remdesivir that a whistleblower had given to him from the CMS (Centers for Medicare & Medicaid Services) database, and the statistics were truly horrifying in terms of how many people were dying after taking this drug, which was over 25% of the patients. And now, the FDA has just approved this killer drug to be used with children, and babies as young as 28 days old.

CDC/FDA Smoking Gun of Smoking Guns

Quiz: If an agency of the federal government revealed they had no basis for constructing a diagnostic test that was used on millions of people; but the test was the cornerstone of a national lockdown; and the lockdown drove the economy off a cliff; and destroyed millions of lives; however, NOW, that agency says, they DO have a basis for the test; would you buy what they’re selling? If your answer is yes, you’re in good company; the company I call Blind, Ignorant, Denialist, Hoaxing Journalists.

FDA Executive Officer: “Almost a Billion Dollars a Year Going into FDA’s Budget from the People we Regulate”

Project Veritas published Part Two of its series on the FDA on Wednesday night which featured FDA Executive Officer, Christopher Cole, speaking about the inner workings of the agency including the FDA’s conflicts of interest, overspending, and why it’s hard for those within the agency to speak out on such abuses. The incendiary footage, which features Cole talking about how the additional money the FDA brings in “gets banked” to be spent on “whatever you can, whether it’s right or wrong,’’ also features Cole discussing reasons why it’s difficult for anyone in government to speak out about practices he sees as “probably excessive.” “I don’t think there’s enough people saying they’re, like, ‘Look, that’s fine, but that’s not right.  So, we’re not going to charge that.’ You don’t want to be that person. You’re not going to have a long shelf life in the agency if you’re always that person,” Cole said. “There’s not an incentive to speak out in government, surprisingly. You would think there would be, but there’s not. It’s better just to just not say anything and just ignore it. The whistleblower, well, it’s high-profile whistleblower statutes and everything, that’s kind of ridiculous,” Cole said before adding “it’s better to just stay quiet and accept.”

Obama FDA Head that Allowed Opioid Crisis to Increase Confirmed to Lead the FDA Again as COVID Shots Set to Join Annual Flu Shots in Windfall for Big Pharma

Apparently Robert Califf did such a good job of helping Big Pharma shield themselves from any liabilities due to the opioid crisis that destroyed the lives of so many Americans while he was head of the FDA under President Obama, that he is being brought back to lead the FDA again to help Big Pharma continue growing in record profits and sales as they get ready to expand the market for the COVID-19 gene-altering shots by having Americans get vaccinated every year, along with the already profitable flu shots. While he was approved to lead the FDA by the Senate in an overwhelming vote of support with an 89-4 Senate vote on his confirmation in 2016, this time around he barely survived the confirmation vote which was 50-46, facing bi-partisan opposition to his confirmation. Yesterday, Project Veritas released a video recording with "FDA Executive Officer, Christopher Cole" who was caught on camera admitting that the FDA was planning making the COVID shots an annual requirement, in a financial windfall for the Pfizer and other COVID-19 vaccine manufacturers. He also confirmed that the FDA works for the pharmaceutical companies who pay the FDA "hundreds of millions of dollars a year to hire and keep the reviewers to approve their products."

Did Recent Court Rulings Force the FDA to Delay Approving Pfizer’s COVID Shots for Infants?

Operation Warp Speed has hit its first bump in the road. The U.S. Food and Drug Administration (FDA) announced yesterday that it was delaying approval of Pfizer's COVID-19 vaccines for young children between the ages of 6 months and 4 years old. Since up until this point the FDA has illegally approved all other Pfizer COVID-19 "vaccines" by simply rubber-stamping Pfizer's own data which is hidden from the public, the question that begs to be answered is, why? Pfizer has worked hard to hide the clinical data from their trials from the public, but recent court rulings have not exactly gone their way. The FDA had originally asked the court to delay releasing their clinical data for 75 years, but then agreed to provide 500 pages per month. In late January, Attorney Aaron Siri reported that a federal judge shot down the FDA’s requested rate of 500 pages per month and instead ordered the FDA to produce at the rate of 55,000 pages per month starting on March 1. Siri also reported that Pfizer was joining the FDA in the case. And why not, since the FDA basically works for Pfizer? Last week, the judge in this case, U.S. District Judge Mark Pittman, denied Pfizer's request (for now) to join the case. The next day, Pfizer redlined changes in their 4th quarter earnings release from 2021, adding language warnings that 'Unfavorable Pre-Clinical, Clinical Or Safety Data' may impact business in 2022. It's too bad for Pfizer that Donald Trump is no longer president, because he could have intervened to help Pfizer get their shots out to those 18 million children by strong-arming the FDA, like he originally did back in December 2020 when he threatened the FDA head, Dr. Stephen Hahn, to approve the COVID-19 shots or be fired.

Attorney Siri: The CDC is Hiding COVID-19 Vaccine Safety Data

Three prior posts explained how the FDA seeks to delay for 75+ years full production of Pfizer’s pre-licensure safety data.  While we have that fight, we submitted a request to the CDC, on behalf of ICAN, for the deidentified post-licensure safety data for the Covid-19 vaccines in the CDC’s v-safe system.  Even though this data is available in deidentified form (meaning, it includes no personal health information), the CDC refused to produce this data claiming it is not deidentified.  So, on behalf of ICAN, we filed a federal lawsuit against the CDC and its parent entity, the U.S. Department of Health and Human Services (HHS), to force the CDC to produce this data to the public.  The CDC should have no issue doing so because it has already made this data available to a private company – Oracle – in deidentified form.  It is telling that Larry Ellison’s company can see the data American taxpayers paid the CDC to collect but the average American and independent scientists cannot?! 

CDC Admits COVID-19 Shots Causing Heart Disease but Won’t Stop the Injections – Does Pfizer Now Control the CDC and FDA?

The United States CDC updated their "Adverse Events" page on COVID-19 shots today where they admit that there are now 1,908 reported cases of myocarditis and pericarditis following COVID-19 shots among young people below the age of 30. This compares to, on the same page, 57 cases of "Thrombosis with thrombocytopenia syndrome (TTS)" and 278 cases of "Guillain-Barré Syndrome (GBS)" for all age groups, not just those under the age of 30. As we have reported in the past, the CDC typically uses "selective bias" when reporting these "adverse events" to make the numbers look much lower than they actually are. But with the cases of heart disease now skyrocketing, even with their selective bias it can be clearly seen that we are dealing with a very high number of these injuries showing that their assertion that these side effects of heart disease are "rare" is completely absurd. When we include all the other cases of myocarditis and pericarditis in their own data within VAERS for young people under the age of 30, the number is actually 3,262 cases. When we remove the age limit of 30 years old, the cases of carditis skyrocket up to 12,855 cases. For another comparison, and again using THEIR DATA from VAERS, if we look at cases of heart disease following all non-COVID vaccines, which include the flu shots, all the childhood vaccines in the CDC schedule, and every other non-COVID vaccine currently being distributed in the U.S. for the same time period (since last December when the COVID-19 shots were given emergency use authorization), we find 125 cases. 12,855 cases of heart disease following COVID-19 experimental shots for the past year, compared to 125 cases of heart disease following all FDA-approved vaccines for the past year. And the CDC calls this "rare"? This is the government data from the CDC and FDA, and it is under-reported, according to experts, by a factor of between 20X to 41X or more. Why are these shots still on the market killing and crippling people with heart disease? There can only be one explanation. Pfizer now controls the FDA and CDC, and I would go so far as to say they control the United States, including deciding who gets elected to approve their products.

One Year Anniversary of President Trump Forcing the FDA to give Emergency Use Authorization to the Pfizer COVID-19 Shot

I am writing this on the eve of the 1 year anniversary, December 11, 2020, of former President Donald Trump pressuring the FDA to give emergency use authorization (EUA) to the Pfizer COVID-19 shots. Moderna's shot was also given an EUA a few days later. Happy Anniversary President Trump! We have created a video to commemorate this most historical day, perhaps the most significant day ever in the history of the United States.

2,809 Dead Babies in VAERS Following COVID Shots as New Documents Prove Pfizer, the FDA, and the CDC Knew the Shots Were Not Safe for Pregnant Women

The latest data dump into the U.S. Government’s Vaccine Adverse Events Reporting System (VAERS) happened yesterday (12/3/21) and covers data through 11/26/2021. There are now 927,740 cases reported to VAERS following COVID-19 shots for the past 11 months, out of the total of 1,782,453 cases in the entire VAERS database filed for the past 30+ years. In addition, we found 2,809 fetal deaths following COVID-19 shots injected into pregnant and child-bearing women for the past 11 months. By way of contrast, using the exact same search parameters in VAERS, but excluding the COVID-19 shots, we found 2,168 fetal deaths following all FDA-approved vaccines for the past 30+ years. That’s an average of 72 fetal deaths per year following all FDA-approved vaccines for the past 30+ years, compared to what is on pace to be 3064 fetal deaths in 1 year following COVID-19 shots. That is an 80% increase in fetal deaths recorded in VAERS following the COVID-19 shots. And yet, the CDC and FDA continue to recommend these EUA shots for pregnant women and nursing mothers. Not only do they recommend these shots for pregnant women, we now have ample evidence that they have known since earlier this year that these shots are dangerous to pregnant women, and causing fetal deaths. This article will link to publicly available data that shows the CDC, FDA, and Pfizer have known from early on that these shots cause fetal deaths. With all the links to the publicly available data supplied in this article, there is more than enough information to immediately issue arrest warrants for Rochelle Walensky, the director of the CDC, Janet Woodcock, the FDA director, and Albert Bourla, the CEO of Pfizer, for mass murder and crimes against humanity.

Vaccine Injury Attorney Suing the FDA: FDA Asks Federal Judge to Grant it Until the Year 2076 to Fully Release Pfizer’s COVID-19 Vaccine Data

Attorney Aaron Siri is a Vaccine Injury attorney, one of just a handful of such attorneys in the U.S. Since the passage of the 1986 National Vaccine Injury Compensation law, one cannot sue pharmaceutical companies for vaccine injuries and deaths. A special U.S. Vaccine Court handles all cases with select judges chosen by the U.S. Government, and there only about 100 lawyers in the United States that are even trained to litigate in this special "court." The irony with COVID-19 vaccine injuries and deaths, is that even this very highly specialized and controlled government court will not try vaccine injury cases related to the COVID-19 experimental shots, mainly because they are still under Emergency Use Authorization and not fully approved by the FDA yet. So Aaron Siri's firm is suing the FDA, since there is no avenue in place within the U.S. Judicial system to sue the drug companies, or anyone else for that matter, for damages caused by the experimental COVID-19 "vaccines." We have previously covered Aaron Siri's lawsuit, which represents brave doctors who have chosen to put their careers on the line to dare to expose vaccine deaths and injuries caused by the experimental shots, and these physicians are the plaintiffs. Today, Attorney Siri published an update on his case against the FDA, where he wrote: "The FDA has asked a federal judge to make the public wait until the year 2076 to disclose all of the data and information it relied upon to license Pfizer’s COVID-19 vaccine.  That is not a typo.  It wants 55 years to produce this information to the public. So, let’s get this straight. The federal government shields Pfizer from liability. Gives it billions of dollars. Makes Americans take its product. But won’t let you see the data supporting its product’s safety and efficacy.  Who does the government work for?"

BOMBSHELL: FDA Allows Whistleblower Testimony that COVID-19 Vaccines Are Killing and Harming People!

The FDA held a Vaccine Advisory Committee meeting yesterday (September 17, 2021) to discuss authorizing a third Pfizer COVID-19 "booster shot." There were signs heading into the meeting this week that there could be some fireworks at this hearing, as two top vaccine research scientists at the FDA, Dr. Marion Gruber and Dr. Phillip Kause, the Director and Deputy Director of the Office of Vaccines Research, recently resigned. This followed a report published in The Lancet from 18 officials at the FDA opposing the Biden Administration's plan to start distributing Pfizer "booster shots" later this month (September, 2021) before the FDA had even approved them. To say that there were fireworks at the Vaccine Advisory Committee meeting yesterday might be a gross understatement. The 18 member committee voted 16 to 2 AGAINST approving the booster shots, although later they did give their endorsement on approving them for people 65 and older. During the "open session" part of the meeting, dissenting doctors questioning the Pfizer shots were given a chance to address the public with their concerns, and they presented to the public REAL data about the shots that up until now has been heavily censored.

After 1,517,211 Injuries and 9,027 Recorded Vaccine Deaths in the U.S. FDA Gives Full Approval to Pfizer COVID-19 Vaccine

After 1,517,211 injuries and 9,027 deaths following the Pfizer COVID-19 vaccines recorded in the U.S. Government's Vaccine Adverse Event Reporting System (VAERS), the FDA today gave full approval to the Pfizer COVID-19 injections for people over the age of 16. Besides the U.S. VAERS, the British Yellow Card reporting system for injuries and deaths following COVID-19 vaccines reports 501 deaths and 293,779 injuries following Pfizer COVID-19 injections. EudraVigilance, the European Union database of suspected drug reaction reports for COVID-19 vaccines, reports 10,616 deaths and 833,498 injuries following Pfizer COVID-19 vaccines. Today is a historic day in the United States, because no pharmaceutical product linked to so many deaths and injuries during its trial period has ever before been approved by the FDA. Just from Europe and the U.S., official government reporting systems list a total of 20,144 deaths and 2,644,488 adverse reactions following Pfizer's injections. We know that these reported numbers, directly from official government health organizations, are severely under-reported, as doctors and other medical personnel are pressured to NOT link these deaths and injuries to the COVID-19 shots. We also know that the same thing is happening in many other countries around the world, as we reported last week that official media sources in Brazil admit that over 32,000 people have died following COVID-19 shots, and one of the approved shots in Brazil is the Pfizer/BioNTech shot. So do you still believe that a worldwide eugenics program in place to reduce the world's population is a "conspiracy theory"?

FDA Wants to Ban Another Natural Supplement with Success in Treating Symptoms of COVID-19

N-acetyl-L-cysteine (NAC) has been on the market as a supplement for decades—why is the FDA attacking it now? It seems obvious that the FDA is clearing the market of affordable NAC supplements in an effort to eliminate competition for NAC drugs that could be coming to market in the next few years. For starters, a drug company is investigating NAC as a treatment for a rare genetic disorder that damages the myelin sheath, which insulates nerve cells in the brain. But that’s just the beginning. A search through the government’s clinical trials database shows considerable interest from the pharmaceutical industry in NAC. There are 17 trials looking at NAC, in both drug and supplement form, in the treatment of COVID.

After 300 Million Injections and as Demand Wanes FDA Finally Issues Warning on mRNA COVID-19 Shots for Heart Failure

After injecting Americans with over 300 million doses of one of the mRNA COVID-19 bioweapon shots since December 13, 2020, the FDA has finally agreed to force Moderna and Pfizer to put warning labels on their shots over a "likely association" between the injections and heart problems, which they claim is "rare." The warning comes as the vast majority of Americans who wanted one of the mRNA injections have already been injected, as demand for the shots has decreased to levels seen back in December, just after the shots were given emergency use authorization and were beginning to be rolled out. According to the CDC's latest report published yesterday, June 23, 2021, "318 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through June 21, 2021," with only 12 million of those doses being the "J&J/Janssen COVID-19 Vaccine." As we have been reporting throughout the rollout of these non-FDA approved injections, hundreds of cases of people suffering heart problems, including DEATH, have been reported to VAERS, the Government database that tracts adverse reactions to "vaccines."

Criminal FDA Authorizes Emergency Use for Pfizer’s mRNA Injections on 12-15 Year-olds – Up to State Governors to Save the Nation’s Children

As expected, the FDA granted emergency use authorization to Pfizer's experimental COVID mRNA shots to be injected into children between the ages of 12 and 15 today. The FDA is a criminal organization comprised of medical professionals with ties to Big Pharma who are serving the pharmaceutical industry, and not the public. None of the COVID-19 injections given emergency use authorization were done so legally. Many scientists and doctors have protested, and even filed official complaints against the FDA, because there are already effective treatments for COVID-19, making an emergency use authorization unnecessary. In addition, the current injections for COVID-19 do not meet the legal definition of a "vaccine," but are an entirely new class of injections that inject an operating system into your body and works directly with your DNA. Many young people aged 16 to their early 20s have already died and been seriously injured following the Pfizer injections, and we have covered their stories here on Health Impact News. There is a eugenic agenda here to reduce the world's population, and for those young girls in the 12 to 15 year age range whose parents allow them to get this experimental injection, most if not all of them will probably become infertile and never be able to bear children, if they survive the shots. Governors can stop this at the State level, and refuse to adopt the FDA Guidelines.

FDA Whistleblower Claims the FDA is Not Properly Inspecting Plants where Vaccines are Manufactured, Mainly Merck Who Will Begin Producing COVID Experimental Vaccines

After it was recently announced that Merck & Co. would take over producing some of the experimental COVID "vaccines" for Johnson and Johnson, an FDA whistleblower has now stepped forward to reveal that the FDA is not properly examining production facilities where these experimental COVID shots are being produced. This is just another routine incident that highlights the incestuous relationship between Big Pharma and government health regulatory agencies like the FDA and the CDC, which primarily work for the pharmaceutical industry to maximize their profits, and are not very concerned about public health at all. Most of the people appointed to these government agencies come out of the pharmaceutical industry, and then return there once they are finished working for agencies like the FDA and the CDC. Merck is now set to join the ranks of pharmaceutical companies producing experimental COVID injections that have a long history of criminal activity. We have previously reported how Pfizer is notorious for previously having the largest criminal settlement with the Department of Justice, and Johnson and Johnson also has a very long criminal rap sheet ranging from their baby powder causing cancer, to flawed hip replacements and multiple product recalls that have harmed millions. So now faced with manufacturing problems in producing enough of the experimental COVID injections, they are turning to another criminal organization to help them, Merck. Merck's vaccines historically have probably killed and maimed more people than any other vaccine manufacturer, and they are still embroiled in lawsuits to this day over some of their vaccines, mainly the measles, mumps, and rubella (MMR) vaccine, and their HPV vaccine, Gardasil. And now they are slated to use a plant to help produce the Johnson and Johnson experimental COVID shots, where employees are deliberately soiling their clothes with blood, urine and feces because they don't want to take the time to use the restrooms and go through the entire sterilization process again, and the FDA is overlooking this. And yet the vast majority of the public remains religiously pro-vaccine and are rushing out to get experimental injections produced by criminal pharmaceutical companies and regulated by criminal government regulatory agencies that are supposed to be overseeing them. The reduction of the world's population is in full swing now, and the pro-vaccine masses are the first ones to be culled.

Unlike UK, U.S. FDA Allows Pregnant and Nursing Women to Receive Experimental Pfizer COVID Vaccine

The U.S. FDA has given emergency use authorization (EUA) to the experimental Pfizer COVID mRNA vaccine, a type of vaccine that has never before been authorized for use in humans. The FDA's EUA for the Pfizer COVID vaccine follows an emergency use authorization in the U.K. about 10 days ago. Both governments have issued guidelines for the new vaccines, one set of guidelines for doctors and healthcare providers who will administer the vaccine, and a shorter set of guidelines for "recipients" who plan on taking the vaccine. Even though these guidelines cover the same vaccine from the same company (Pfizer), there are notable differences. The UK guidelines, issued by the UK Department of Health and Social Care and the Medicines & Healthcare products Regulatory Agency, give strict warnings to doctors NOT to give the vaccine to women who are pregnant or nursing, or to women planning on becoming pregnant, with a warning about potential infertility issues. However, the U.S. FDA's guidelines contain no such warning.