Health

FDA: Safety Problems Prompted Review of Homeopathic Remedies

Published

11 years ago

April 22, 2015

This June 16, 2009 file photo shows Zicam Cold Remedy nasal gel in Boston. A top federal drug regulator says that increased safety problems with homeopathic remedies contributed to the governments decision to revisit its oversight of the products at a public hearing this week. The Food and Drug Administration on Tuesday, April 21, 2015, wrapped up a two-day meeting to hear from supporters and critics of products like Zicam Allergy Relief and Cold-Eeze, alternative remedies that are protected by federal law, but not accepted by mainstream medicine. (AP Photo/Eric Shelton)

MATTHEW PERRONE, AP Health Writer

WASHINGTON (AP) — A top federal drug regulator says increased safety problems with homeopathic remedies contributed to the government’s decision to revisit its oversight of the products this week.

The Food and Drug Administration on Tuesday wrapped up a two-day meeting to hear from supporters and critics of products like Zicam Allergy Relief and Cold-Eeze, alternative remedies that are protected by federal law, but not accepted by mainstream medicine.

Similar to dietary supplements, the FDA does not review the safety or effectiveness of homeopathic remedies before they are sold. But unlike supplements, homeopathic medicines can state that they are intended for specific medical symptoms and conditions.

The FDA’s Cynthia Schnedar, a director of drug compliance, said the agency has issued 40 warning letters to homeopathic product makers since 2009 amid increasing U.S. sales.

In perhaps the most serious case, in 2009 the FDA ordered the maker of Zicam to stop marketing three products that contained zinc gluconate. The agency linked those products to 130 reports from consumers who said they lost their sense of smell.

In 2010, the FDA warned about reports of toxicity in children taking Hyland Homeopathic’s teething tablets, which contained a berry-derived toxin called belladonna that can be poisonous in larger doses.

And last month the agency warned U.S. patients with asthma not to rely on homeopathic products claiming to treat the respiratory condition, which can cause fatal complications if not properly managed.

Despite such problems Schnedar stressed that this week’s FDA meeting was a “listening session,” and that the agency has not reached any decision about whether to alter its regulations.

“We’re gathering information to allow us to consider whether to adjust the current enforcement policies we have in place,” Schnedar said in an interview.

The FDA hasn’t revisited its oversight of homeopathic products since 1988, when it essentially exempted the industry from basic production standards that are mandatory for traditional drugs, like listing ingredients and dosibizng levels on product labels.

Zicam and hundreds of other homeopathic remedies are often sold alongside over-the-counter drugs like Tylenol and aspirin at pharmacies across the U.S. But homeopathic medicine is based on a 200-year old theory unsupported by modern science: that ingredients which create certain symptoms in healthy people are effective in treating the disease that causes the same symptoms.

A key principle of traditional homeopathy holds that the more diluted a remedy is, the better it works. Today, many remedies marketed as homeopathic contain heavily diluted drugs, vitamins and minerals. For instance, Zicam contains a heavily diluted dose of zinc as its “active ingredient.”

On Monday, industry executives and lobbyists argued that the current FDA framework works well for homeopathy. Representatives from the Consumer HealthCare Products Association, which represents homeopathic manufacturers, emphasized that consumers like having easy access to alternative treatments.

But industry critics argued that many consumers do not understand how homeopathic products differ from conventional medicines.

“Stocking homeopathic remedies labeled for specific symptoms or conditions alongside conventional over-the-counter drugs on the pharmacy or supermarket shelves is innately misleading,” said Dr. Adriane Fugh-Berman, an associate professor at Georgetown University Medical Center.

She and others want the FDA to require homeopathic remedies to undergo the same safety and effectiveness reviews as conventional drugs. But failing that, Fugh-Berman said that the products should carry a disclaimer warning that they have not been shown to treat or prevent any disease or condition.

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Rep. Kamlager-Dove Introduces Bill to Protect Women in Custody After Reports Detailing Miscarriages and Neglect

The Pregnant Women in Custody Act would expand safeguards beyond the federal prison system to include women detained by U.S. Immigration and Customs Enforcement, U.S. Customs and Border Protection and the Office of Refugee Resettlement. The proposal follows reports of pregnant women being shackled, denied medical care and suffering miscarriages while in immigration detention.

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9 hours ago

May 17, 2026

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By Bo Tefu, California Black Media

Congresswoman Sydney Kamlager-Dove (D-CA-37) on May 7, reintroduced updated legislation aimed at strengthening protections and healthcare standards for pregnant and postpartum women held in federal custody, including in immigration detention facilities.

The Pregnant Women in Custody Act would expand safeguards beyond the federal prison system to include women detained by U.S. Immigration and Customs Enforcement, U.S. Customs and Border Protection and the Office of Refugee Resettlement. The proposal follows reports of pregnant women being shackled, denied medical care and suffering miscarriages while in immigration detention.

The legislation builds on a bipartisan version previously passed by the House during the 117th Congress. The updated bill includes new standards for healthcare access, mental health and substance use treatment, high-risk pregnancy care, family unity protections and increased federal oversight.

“Proper pregnancy care is a human right, regardless of your immigration or incarceration status,” Kamlager-Dove said in a statement. “It’s unacceptable that there are virtually no legal safeguards for pregnant women in federal custody.”

The bill would also limit the use of restraints and restrictive housing for pregnant women, improve data collection on maternal health in custody and require additional staff training and enforcement measures.

Supporters of the measure said the legislation is intended to address long-standing concerns about maternal healthcare and safety in detention settings, particularly for Black women and low-income women who are disproportionately impacted by incarceration and health disparities.

“Pregnant women in custody should never be subjected to dangerous and inhumane treatment that threatens their health, dignity, or the well-being of their babies,” said Patrice Willoughby, chief of policy and legislative affairs for the NAACP and a longtime public policy and government affairs strategist, in a statement.

A 2021 report estimated there are about 58,000 admissions of pregnant women into U.S. jails and prisons each year. Kamlager’s statement also cited a recent investigation by NBC News and Bloomberg Law that identified allegations of severe mistreatment or medical neglect involving at least 54 pregnant women or families in county jails between 2017 and 2024.

Federal policy under the Department of Homeland Security restricts the detention of pregnant, postpartum and nursing immigrants except in extreme cases. However, the agency reported that ICE deported 363 pregnant, postpartum or nursing women between January 2025 and February 2026, including 16 recorded miscarriages during that period.

The bill is cosponsored by several House Democrats and backed by organizations including the NAACP and the Vera Institute of Justice.

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How Is AI Affecting California? The State Wants You to Share Your Story

The program marks the first time the state has opened the platform to all Californians. State officials said the effort is designed to give residents a direct role in discussions about how AI should be regulated and used as the technology rapidly expands across industries.

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10 hours ago

May 17, 2026

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By Bo Tefu, California Black Media

Gov. Gavin Newsom announced May 7 that California is expanding its Engaged California digital democracy initiative statewide, inviting residents to help shape future state policies on artificial intelligence (AI) and its impact on jobs and the economy.

“We’ve got to be clear-eyed about this moment: AI is moving fast, bringing enormous opportunity, but also real risks,” Newsom said in a statement. “Californians deserve a seat at the table as we shape what’s to come.”

The initiative will roll out in two phases. Beginning immediately, Californians can sign up online to share how AI is affecting their work and communities and provide ideas for possible government action. Later this summer, a smaller group reflecting the state’s workforce demographics will participate in live discussions focused on developing policy recommendations.

State officials said the goal is to identify areas of agreement among Californians and provide policymakers with public feedback as the state develops future AI regulations and workforce strategies.

Engaged California is modeled after digital democracy programs used in Taiwan and is intended to encourage structured public discussion rather than social media-style debate. Officials described the effort as a form of “deliberative democracy” aimed at helping residents engage directly in state decision-making.

“The more Californians are engaged in the democratic process, the better able we’ll be to confront the challenges we face together,” said Nick Maduros, California Secretary of Government Operations, in a statement.

The statewide launch builds on two earlier pilot programs. One pilot gathered public input following the Los Angeles firestorms to help guide recovery efforts, while another collected ideas from state employees about improving government operations.

California has positioned itself as a national leader in AI policy and development. Since 2023, the Newsom administration has introduced initiatives focused on responsible AI use in government, cybersecurity protections, workforce training and regulations targeting risks such as deepfakes and AI-generated robocalls.

The state has also partnered with companies in Silicon Valley — including NVIDIA, Google, Adobe, IBM and Microsoft — to expand AI education and workforce training programs across California schools and universities.

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California Launches Free Diaper Program for Newborns Statewide

The initiative, called Golden State Start, will provide 400 free diapers to every newborn delivered at participating California hospitals beginning this summer. The state is partnering with Baby2Baby, a California-based nonprofit that distributes essential items to children in need nationwide.

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10 hours ago

May 17, 2026

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By Bo Tefu, California Black Media

Gov. Gavin Newsom announced Friday that California will launch a first-in-the-nation program providing free diapers to families with newborns, part of a broader effort to lower costs for parents and improve infant health outcomes.

The initiative, called Golden State Start, will provide 400 free diapers to every newborn delivered at participating California hospitals beginning this summer. The state is partnering with Baby2Baby, a California-based nonprofit that distributes essential items to children in need nationwide.

State officials said hospitals participating in the program will give families the diapers when they are discharged after birth, helping parents leave with an immediate supply of newborn essentials.

“Every baby born in California deserves a healthy start in life,” Newsom said in a statement. He said the program is part of California’s broader affordability efforts, which also include free school meals, universal preschool for four-year-olds and expanded after-school programs.

The announcement comes ahead of Mother’s Day and is tied to the administration’s broader CalRx initiative, which aims to reduce costs for essential products and medications. State officials said California is also exploring ways to lower diaper prices by challenging high costs from major brands.

The first year of the program will prioritize hospitals serving large numbers of Medi-Cal patients, with plans to expand to additional hospitals and birthing centers over time. Officials said the effort is intended to reduce financial pressure on low-income families and improve infant and maternal health by ensuring parents have access to clean diapers.

“California families deserve to feel supported during one of life’s more exciting, yet vulnerable transitions,” First Partner Jennifer Siebel Newsom said in a statement. She said the program would allow parents to focus on caring for their newborns instead of worrying about basic supplies.

According to Baby2Baby, one in two families in the United States struggles to afford diapers. The organization has distributed more than half a billion items to children over the past 15 years through partnerships with shelters, hospitals, foster care programs and schools.

State officials said Baby2Baby will oversee diaper purchasing, warehousing and distribution through its existing hospital and community partnerships across California.