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FDA warns websites selling unapproved Botox for cosmetic purposes

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FDA warns websites selling unapproved Botox for cosmetic purposes
News

News

FDA warns websites selling unapproved Botox for cosmetic purposes

2025-11-06 04:03 Last Updated At:04:10

Associated Press (AP) — U.S. health regulators on Wednesday sent warning letters to 18 websites selling counterfeit or unapproved versions of Botox and similar injectable drugs commonly used to smooth wrinkles.

The Food and Drug Administration said it was taking action after receiving reports of injuries in connection with the products, including toxic side effects.

Botox is a diluted, purified form of botulinum, one of the most toxic substances in the world. The ingredient works by temporarily blocking nerve signals and causing muscles to relax. While most famously approved for cosmetic use, Botox is also approved in the U.S. for a number of medical conditions, including muscle spasms, eye disorders and migraines.

The FDA warning letters mostly went to cosmetic websites. In each case, the FDA said the companies were offering unofficial or mislabeled versions of Botox-like drugs that haven't been approved by the agency. In addition to the original drug, introduced by Allergan in 1989, the FDA has approved several competing versions.

FDA-approved Botox drugs carry the agency's most serious warning, a boxed label alerting doctors and patients that the medications can cause serious or life-threatening side effects.

In rare cases, the toxin can spread beyond the injection site to other parts of the body, paralyzing or weakening muscles needed for breathing and swallowing. Signs of botulism include difficulty swallowing or breathing, slurred speech and muscle weakness. Those symptoms can occur several hours after an injection.

In a press release Wednesday, the FDA said patients should only receive the drugs from health professionals who are licensed and trained to administer them. Patients experiencing signs of botulism should “seek immediate medical care,” the agency noted.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

FILE - A patient receives a Botox injection at a clinic in Arlington, Va., on June 5, 2009. (AP Photo/Jacquelyn Martin, File)

FILE - A patient receives a Botox injection at a clinic in Arlington, Va., on June 5, 2009. (AP Photo/Jacquelyn Martin, File)

JERUSALEM (AP) — The White House says it is moving into the second phase of President Donald Trump’s Gaza ceasefire plan – breathing new life into a proposal that aims to rebuild the war-ravaged area and reshape the wider Middle East.

Trump’s Mideast envoy, Steve Witkoff, broke the news Wednesday in a post on X, saying the new phase will include the establishment of a transitional Palestinian governing committee and begin the complicated tasks of disarming Hamas and reconstruction.

But the announcement included few details about the new Palestinian committee or other key aspects of the plan, signaling just how much work lies ahead.

Trump's 20-point plan — which was approved by the U.N. Security Council — lays out an ambitious vision for ending Hamas’ rule in Gaza. If successful, it would see the rebuilding of a demilitarized Gaza under international supervision, the normalization of relations between Israel and the Arab world, and the creation of a possible pathway to Palestinian independence.

But if the deal stalls, Gaza could be trapped in an unstable limbo for years to come, with Hamas remaining in control of parts of the territory, Israel’s army enforcing an open-ended occupation, and its residents stuck homeless, unemployed, unable to travel abroad and dependent on international aid to stay alive.

“We’re going to do our best to try and see if we can work with the Palestinian people to try something new,” said a U.S. official, speaking on condition of anonymity to discuss the evolving plan. “It will be hard to do,” he acknowledged.

Here is a closer look at the next stages of the ceasefire and the potential pitfalls.

The ceasefire took effect on Oct. 10, halting two years of fighting between Israel and Hamas. It also included the release of all remaining hostages held in Gaza in exchange for hundreds of Palestinians held by Israel.

The ceasefire has largely held, though both sides accuse each other of ongoing violations. Israeli fire has killed more than 400 Palestinians, according to Gaza health officials. Israel says it has targeted militants or responded to violations of the ceasefire, but the Palestinians say scores of civilians have been shot.

Palestinian militants, meanwhile, continue to hold the remains of the last hostage — an Israeli police officer killed in the Hamas-led Oct. 7, 2023, attack that triggered the war. Israeli Prime Minister Benjamin Netanyahu has made clear he is in no rush to move forward until the remains are returned.

Netanyahu appeared to play down Witkoff’s announcement as symbolic, calling the creation of a new Palestinian committee a “ declarative move.”

The new committee will consist of independent Palestinian experts who are to run Gaza’s daily affairs under American supervision.

Wednesday’s announcement didn't say who will serve on the committee. But the other mediators of the ceasefire — Egypt, Turkey and Qatar — said it would be led by Ali Shaath, an engineer and former deputy minister in the Palestinian Authority in the West Bank.

The U.S. official who spoke on the condition of anonymity said other names are expected in the next two days, and the committee will focus on attracting investment and improving the quality of life.

“This really will be a technocratic committee,” he said. “They seem to be a group that wants to have peace.”

The committee will report to the Board of Peace, a group of world leaders supervising the ceasefire and led by Trump. If the Palestinian committee is seen as just a façade, it risks not gaining public support.

Also, its exact powers remain unclear. Hamas has said it will dissolve its government once the committee takes office, but it has shown no signs that it will dismantle its military wing or security forces.

The board will oversee the ceasefire, reconstruction and an open-ended reform process by the Palestinian Authority, with the goal of one day allowing the internationally recognized authority to return to Gaza to govern.

The U.S. official said invitations for the board have been extended, but he declined to name any of the people expected to join. “It’s going to be a great list,” he said.

The key challenge will be forming a board that can work with Israel, Hamas, the mediators and international aid agencies.

One key appointment appears to have been made. Nickolay Mladenov, a former Bulgarian politician and U.N. Mideast envoy, is expected to serve as the board’s on-the-ground representative. He already has met with Netanyahu and Palestinian leaders in the occupied West Bank.

Trump's plan calls for the formation of an International Stabilization Force to maintain security and train Palestinian police to one day to take over. That force hasn't been formed yet, and a deployment date hasn't been announced.

The U.S. official insisted there is “great excitement” over the force and said there would be important announcements in the coming weeks.

But the force’s command structure and authorities remain unknown.

Hamas said it will oppose any attempts by the force to disarm it, and contributing nations may not to want to risk clashes with the militant group. Israel, meanwhile, is hesitant to trust an international body with its security needs.

Trump’s plan calls for an economic development outline to “rebuild and energize Gaza,” which suffered widespread destruction during the war and where most of the territory’s 2 million people are displaced and unemployed.

Still, no such plan has been announced, and it remains unclear who will pay for a process the U.N. estimates will cost $70 billion.

The ceasefire deal calls for Hamas to surrender its weapons under the supervision of international monitors. Militants who disarm will be granted amnesty and the option to leave Gaza.

However, Hamas, whose ideology is based on armed resistance against Israel, has said it won't disarm until Israel ends its occupation of Palestinian territories.

Bassem Naim, a senior Hamas official, told The Associated Press last month that the group is open to “ freezing or storing” its weapons while a political process takes place, perhaps over many years. It is unclear whether that would be sufficient for Israel.

Failure to disarm Hamas could lead to renewed fighting with Israel and clashes with international troops, and could block progress on the rest of the peace plan.

Under the ceasefire, Israel is to withdraw from all of Gaza, with the exception of a small buffer zone along the border. At the moment, Israel retains control of just over half of Gaza.

The plan says further withdrawals will be based upon “standards, milestones and timeframes linked to demilitarization” to be negotiated by Israel, the U.S., the international force and other “guarantors.”

There are no firm timelines for further withdrawals, and Israel may refuse to pull back further.

The plan calls for an overhaul of the Palestinian Authority, which runs the West Bank, and the creation of conditions for a “credible pathway” to Palestinian statehood.

Palestinian officials say they have begun making reforms in key areas such as corruption, the education system and payments to families of prisoners convicted in attacks on Israelis.

Israel rejects the creation of a Palestinian state and opposes any role for the authority in postwar Gaza. Without a pathway to statehood, any Palestinian support for the new system could crumble. The plan also offers no clear benchmarks or timelines for the reform process.

US Special Envoy Steve Witkoff delivers a speech upon the signing of the declaration on deploying post-ceasefire force in Ukraine during the 'Coalition of the Willing' summit on security guarantees for Ukraine, at the Elysee Palace in Paris Tuesday, Jan 6, 2026. (Ludovic Marin, Pool photo via AP)

US Special Envoy Steve Witkoff delivers a speech upon the signing of the declaration on deploying post-ceasefire force in Ukraine during the 'Coalition of the Willing' summit on security guarantees for Ukraine, at the Elysee Palace in Paris Tuesday, Jan 6, 2026. (Ludovic Marin, Pool photo via AP)

Palestinians walk amid buildings destroyed by Israeli air and ground operations in Gaza City Thursday, Jan. 15, 2026. (AP Photo/Jehad Alshrafi)

Palestinians walk amid buildings destroyed by Israeli air and ground operations in Gaza City Thursday, Jan. 15, 2026. (AP Photo/Jehad Alshrafi)

Makeshift tents shelter displaced Palestinians stand among buildings destroyed by Israeli air and ground operations in Gaza City Thursday, Jan. 15, 2026. (AP Photo/Jehad Alshrafi)

Makeshift tents shelter displaced Palestinians stand among buildings destroyed by Israeli air and ground operations in Gaza City Thursday, Jan. 15, 2026. (AP Photo/Jehad Alshrafi)

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