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Don’t Be Fooled: Here’s What ‘FDA Approved’ Really Means

Posted 19 February 2024

From The Conversation

If you’ve ever reached for a bottle of moisturizer labeled “patented” or “FDA approved,” you might want to think twice. In a recent study of hundreds of advertisements, I found that supplements and beauty products often misleadingly use these terms to suggest safety or efficacy.

As a law professor, I suspect this is confusing for consumers, maybe even dangerous. Having a patent means only that you can stop others from making, using, selling or importing your invention. It doesn’t mean the invention works or that it won’t blow up in your face.

“FDA approved,” meanwhile, means a product’s benefits have been found to outweigh its risks for a specific purpose – not that it’s of high quality or low risk in general.

Led astray by the label

I wanted to know whether companies exploit these sorts of misunderstandings, so I analyzed hundreds … Read the rest

FDA warns about tainted arthritis and pain products

Posted 10 Jan 2024

The FDA has identified 25 products promoted for arthritis and pain management that contain drug ingredients not listed on product labels, including some found in prescription drugs. The agency advises these products are only a small fraction of potentially dangerous products marketed online and in stores. Such products may cause serious side effects and may interact with medications or dietary supplements.

Tainted Arthritis | Pain Products

https://www.fda.gov/drugs/medication-health-fraud/tainted-arthritis-pain-products

FDA is notifying consumers of certain products promoted for arthritis and pain management that have been found to contain hidden ingredients and may pose a significant health risk. The public notifications listed below include those products FDA testing found to contain active drug ingredients not listed on the product labels, including some with ingredients found in prescription drugs. These products may cause potentially serious side effects and may interact with medications or dietary supplements a consumer is taking. Consumers … Read the rest

Paediatric melatonin poisonings increasing

Posted 12 June 2022

Melatonin, which is regulated by the U.S. Food and Drug Administration as a dietary supplement, is widely used as a sleep aid. According to an analysis of 260,435 reports of ingestion of melatonin by teenagers and preteens made to the American Association of Poison Control Centers’ National Poison Data System from 2012 to 2021:

  • 94.3% of the ingestions were unintentional
  • 83.8% were among children under age six
  • 17.2% involved symptoms, mostly of the gastrointestinal, cardiovascular, or central nervous systems
  • 99.0% occurred in the home
  • 88.3% were managed on-site
  • among 27,795 patients who received care at a health care facility, 19,892 (71.6%) were discharged, 4,097 (14.7%) were hospitalized, and 287 (1.0%) required intensive care
  • most of the hospitalized were teenagers with intentional ingestions
  • 4,555 (1.6%) resulted in more serious outcomes including five children who required mechanical ventilation and two died
  • pediatric ingestion reports increased from 8,337 in
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How to stay up-to-date on medical scams, quackery, deadly treatments

Posted on 25 February 2019

By Erin Blakemore February 23 2019

Washington Post

A “cure” that seems too good to be true. A doctor who profits from ineffective or dangerous “treatments.” A product that doesn’t do what it says. All three are health-care frauds – and they can cheat you out of more than money.

But how can you arm yourself against these hucksters and scams? The Food and Drug Administrations’s Health Fraud Scams website is a good start.

The site offers information on all sorts of medical scams, from unlawful sales of medication to new products and common consumer boondoggles. It collects news bites and news releases from the agency, including statements on the FDA’s newest product warning letters and updates on criminal investigations.

Conditions such as erectile dysfunction, cancer, Alzheimer’s disease and obesity are represented among the FDA’s warnings. A variety of videos can help you boost your Read the rest

You can’t use pills as a sunscreen

Posted 24 May 2018

From ScienceAlert

You Can’t Use Pills as a Sunscreen, And Apparently The FDA Needs to Remind Us of That

By Mike McRae 24 May 2018

Owners of companies marketing ‘sun-protection’ pills have been warned by the US Food and Drug Administration (FDA) to cease making spurious claims, or risk breaking the law.

Meanwhile the FDA also has a word of warning for the rest of us; a number of methods have been proven to reduce the risk of damage posed by the Sun’s UV radiation, and dietary supplements just aren’t one of them.

Four products have been specifically called out by the recent statement: Advanced Skin Brightening Formula by GliSODin Skin Nutrients, Sunsafe Rx by Napa Valley Bioscience, Solaricare by Pharmacy Direct, and Sunergized LLC’s Sunergetic.

It’s claimed that by taking these nutritional supplements, consumers can reduce the risks posed by UV radiation

For example, 

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Ondamed devices

Posted 26 April 2018

On the Ondamed website, the following claims are made:

ONDAMED; Focused Tissue Stimulation And Biofeedback
A Breakthrough Technology for you and your patients

After more than 20 years of research and clinical use in Europe, North America, Asia and Australia , these advanced Class II-a medical technologies are approved in many countries for use by medical healthcare professionals as:
Pulsed Electromagnetic Field Therapeutic Medical Devices for Tissue Stimulation with Intended Use for Pain Relief, Soft Tissue Injuries, and Wound Healing.

Does Ondamed devices work? Are they a scam?

I could not find a single study evaluating this device in PubMed (PubMed comprises more than 28 million citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites). So their claim, “more than 20 years of research and clinical use”Read the rest

FDA Pursues Unproven Cancer Claims

Posted 21 December 2017

December 19, 2017

FDA Pursues Unproven Cancer Claims

Rebecca Voelker, MSJ

JAMA.  2017;318(23):2288. doi:10.1001/jama.2017.19150

Four companies have received FDA warning letters for selling products online that agency officials said made unproven anticancer claims and contained a component of the marijuana plant.

The products reportedly contained cannabidiol (CBD), which isn’t FDA approved for any indication. Such products are marketed in a variety of forms including oil drops, capsules, syrup, tea, and topical lotion or cream. Selling unapproved products with unsubstantiated therapeutic claims violates the federal Food, Drug, and Cosmetic Act and could harm patients, according to FDA officials.

Claims made on web pages, online stores, and social media touted the products’ abilities to combat tumor and cancer cells, make cancer cells “commit suicide” without killing other cells, and inhibit cell division and growth in certain types of cancer. Some of the products also were marketed as alternative Read the rest

Products Claiming to “Cure” Cancer Are a Cruel Deception

Posted 27 April 2017

Products Claiming to “Cure” Cancer Are a Cruel Deception

Food and Drug Administration

Beware of products claiming to cure cancer on websites or social media platforms, such as Facebook and Instagram. According to Nicole Kornspan, M.P.H., a consumer safety officer at the U.S. Food and Drug Administration (FDA), they’re rampant these days.

“Anyone who suffers from cancer, or knows someone who does, understands the fear and desperation that can set in,” says Kornspan. “There can be a great temptation to jump at anything that appears to offer a chance for a cure.”

Read the rest

FDA cracks down on companies pushing fraudulent cancer claims

Posted 26 April 2017

FDA cracks down on companies pushing fraudulent cancer claims

By Laurie McGinley April 25 at 4:55 PM

Washington Post

The Food and Drug Administration ordered 14 companies to stop making bogus claims about cancer cures – including asparagus extract, exotic teas and topical creams for pets – or face possible product seizures and criminal prosecution.

The letters covered more than five-dozen unapproved products that the companies touted as preventing, treating or curing cancer, a violation of federal law, the agency said. The items included pills, ointments, oils, drops, teas and diagnostic devices.

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FDA – Illegally Sold Cancer Treatments

Posted 26 April 2017

The FDA has issued 14 warning letters and four online advisory letters to companies illegally selling more than 65 products that claim to prevent, diagnose, treat, mitigate or cure cancer. The products are marketed and sold without FDA approval, most commonly on websites or social media platforms. They have not been reviewed by FDA for safety and efficacy, and can be dangerous to both people and pets.

Continue reading at https://www.fda.gov/ForConsumers/ProtectYourself/HealthFraud/ucm533465.htm

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