Health

FDA: Safety Problems Prompted Review of Homeopathic Remedies

Published

10 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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Related Topics:Cold-Eeze fda homeopathic remedies Zicam

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Activism

LIVE! — TOWN HALL ON RACISM AND ITS IMPACT — THURS. 11.14.24 5PM PST

Join us for a LIVE Virtual Town Hall on the Impact of Racism hosted by Post News Group Journalist Carla Thomas and featuring Oakland, CA NAACP President Cynthia Adams & other Special Guests.
Thursday, November 14, 2024, 5 p.m. – 6:30 p.m. PST

Published

1 week ago

November 12, 2024

Oakland Post

Discussion Topics:
• Since the pandemic, what battles have the NAACP fought nationally, and how have they impacted us locally?
• What trends are you seeing concerning Racism? Is it more covert or overt?
• What are the top 5 issues resulting from racism in our communities?
• How do racial and other types of discrimination impact local communities?
• What are the most effective ways our community can combat racism and hate?

Your questions and comments will be shared LIVE with the moderators and viewers during the broadcast.

STREAMED LIVE!
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California Black Media

Gen. Election Update: Tracking Your Votes on Ballot Propositions — and What They Mean for Our Communities

In the Nov. 5 General Election, Californians cast their votes on ten propositions addressing issues from education and climate funding to prison labor and the minimum wage.

Published

2 weeks ago

November 6, 2024

Oakland Post

By Joe W. Bowers Jr., California Black Media

In the Nov. 5 General Election, Californians cast their votes on ten propositions addressing issues from education and climate funding to prison labor and the minimum wage.

Below is a breakdown of the propositions, their potential impact and an update on how we voted on them.

Likely to Pass:

Proposition 2: Bonds for Public School and College Facilities
With 56.7% support, Prop 2 is on track to pass. This measure would allocate $10 billion to repair and upgrade K-12 and community college facilities, especially in under-resourced schools. For students, this funding could lead to safer and more supportive learning environments.

Proposition 3: Constitutional Right to Marriage
Prop 3 currently has 61.4% support and is likely to pass. This measure aims to amend California’s constitution to affirm marriage rights for all. For LGBTQ+ individuals in our communities, this is a powerful affirmation of equality and inclusion.

Proposition 4: Bonds for Water, Wildfire, and Climate Risks
Currently passing with 57.8%, Prop 4 is on track to deliver $10 billion for projects that address water quality, wildfire prevention, and climate resilience. This could have a significant impact on communities that face the harshest effects of climate change.

Proposition 34: Restricts Spending of Prescription Revenues
Prop 34 is narrowly passing with 51.4% support, indicating that it may succeed. The measure would require specific healthcare providers to use 98% of revenue from federal drug discount programs on direct patient care. This could improve healthcare access for low-income residents.

Proposition 35: Provides Permanent Funding for Medi-Cal
With 66.8% of voters in favor, Prop 35 is on course to pass, securing permanent funding for Medi-Cal, California’s low-income healthcare program. For many in our communities who depend on Medi-Cal, this measure promises stability and continued access to essential healthcare services.

Proposition 36: Increased Sentencing for Certain Drug and Theft Crimes
With strong support at 70.5%, Prop 36 is poised to pass, increasing penalties for specific theft and drug offenses. This measure would partially roll back sentence reductions established by Prop 47, sparking concerns about potential increases in incarceration rates.

Likely to Fail:

Proposition 5: Bonds for Affordable Housing and Infrastructure
With 56.4% of voters opposed, Prop 5 is likely to fail. The measure aimed to reduce the voting threshold for local bonds from two-thirds to 55%, making it easier to fund affordable housing. Without it, local governments will continue to face higher approval requirements, potentially slowing progress on affordable housing solutions.

Proposition 6: Eliminates Forcing Inmates to Work
Currently failing with 54.9% opposed, Prop 6 is expected to be defeated. This measure would have ended involuntary labor for incarcerated individuals, a practice critics argue disproportionately affects Black inmates. It’s likely failure means the prison labor system will remain unchanged.

Proposition 32: Raises Minimum Wage
With 52.1% of voters opposing it, Prop 32 appears likely to fail. This measure would have raised the minimum wage to $18 an hour. While proponents argued it would provide greater financial stability for low-wage workers.

Proposition 33: Local Government Residential Rent Control
With 61.9% voting “no,” Prop 33 is expected to fail, meaning that local governments won’t gain expanded authority to enact rent control. Real estate groups argued that this measure could hinder housing development. Its failure means that current rent control laws will remain in place, leaving fewer protections for renters.

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California Black Media

Covered California Open Enrollment Began Nov. 1

Open enrollment for Covered California kicked off on Nov. 1, 2024, offering individuals, families, and businesses a chance to secure quality, affordable health insurance for the upcoming year. This annual enrollment period allows California residents to choose from a variety of health plans that meet their specific needs. Covered California offers comprehensive coverage, including preventive care and financial assistance to help eligible applicants lower their monthly premiums.

Published

2 weeks ago

November 6, 2024

Oakland Post

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By Bo Tefu, California Black Media

Covered California offers comprehensive coverage, including preventive care and financial assistance to help eligible applicants lower their monthly premiums. The program features insurance plans from leading providers, ensuring access to essential health services such as doctor visits, hospital care, and mental health services.

This year, notable updates include expanded financial assistance, which increases the support available for eligible households to help offset monthly costs. Additionally, consumers will find greater plan flexibility, allowing them to select options that fit their lifestyles and budgets. Access to no-cost preventive services — like vaccinations, screenings, and annual check-ups — remains a priority.

Key enrollment deadlines are set as follows:

The open enrollment period runs from Nov. 1, 2024, to Jan. 31, 2025.
Those who enroll by Dec. 15, 2024, will have their coverage start on Jan. 1, 2025.

To facilitate enrollment, applicants can fill out an inquiry form on the Covered California website, reach out to Certified Enrollment Counselors, or contact Covered California directly at (888) 234-5366 or via email at GetCovered@cbhn.info.

The California Black Health Network (CBHN) collaborates with Covered California to advocate for health equity, focusing on underserved communities, including unemployed and gig workers. CBHN’s certified enrollers engage in outreach and onsite signups to help individuals access affordable healthcare options.