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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

Most direct-to-consumer medical tests advertised online found not useful

Posted 30 January 2024

Australian researchers have found most direct-to-consumer (DTC) diagnostic, screening and risk-monitoring tests sold online are unlikely to benefit the average consumer.

Reference: Shih P, and others. Direct-to-consumer tests advertised online in Australia and their implications for medical overuse: Systematic online review and a typology of clinical utility. BMJ Open, 13(12):e074205, 2023

Two of the researchers independently conducted systematic searches using Google and Google Shopping in October 2020 and identified 177 home self-tests, 65 self-collected direct-access pathology tests (DAPTs), and 242 lab-collected DAPTs. Out of all 484 tests, researchers found:

  • 7% had potential clinical utility
  • 6% had limited clinical utility
  • 9% were non-evidence-based commercial ‘health checks’
  • 7% had methods and/or target conditions not recognized by the general medical community

The last category included these methods lacking clinical validity for conditions they’re intended to test for:

  • (a) hair metal and mineral analysis, and mycotoxin test for environmental
Read the rest

The Benefits and Side Effects of Ginseng

Posted 29 January 2024

What do more than 100 clinical trials on red ginseng, white ginseng, and American ginseng show?
An investigation by Dr Michael Greger M.D. FACLM
Read the rest

Researchers warn of hazards of inadequately regulated dietary supplements

Posted 15 Jan 2024

After a review of several databases, researchers with Touro College of Pharmacy and Nova Southeastern University’s College of Pharmacy have identified a total of 79,071 reported adverse events related to the use of dietary supplements. The events were reported to U.S. Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN) between 2004 and 2021. Their searches for adverse-event reports included the use of vitamin E (vitamin derivative), beta-sitosterol (plant sterol) yohimbine, kava kava, kratom, garcinia cambogia, herbal products, and OxyElite Pro (marketed for weight loss).

Key points made in their paper include:

  • Vitamin E supplementation has documented interaction with several routine medications.
  • Over a thousand adverse events regarding the use of a prostate support supplement called Super Beta Prostate containing beta-sitosterol were reported to CFSAN in the past two decades. Most of the reports involved finding blood in the urine.
  • Poison centers
Read the rest

FDA warns about complications of unapproved fat-dissolving injections.

Posted 14 Jan 2024

The U.S. Food and Drug Administration (FDA) has received reports of adverse reactions to fat-dissolving injections that are not FDA-approved. The reactions have included permanent scars, serious infections, skin deformities, cysts, and deep, painful muscle knots. In addition, improper or unsafe injection practices by unlicensed personnel can increase the risk of scarring and skin infections. The safe and effective uses of these products depend on the correct number and location of injections, proper needle placement, and proper administration technique. Some consumers received the injections at clinics or medical spas by personnel who might not have been properly licensed to give the injections.

Some consumers who reported complications purchased the drugs online and injected it themselves. Consumers should not purchase ingredients for unapproved fat-dissolving injections or inject the drugs themselves.

Unapproved fat-dissolving injections are being marketed online under brand names such as Aqualyx, Lipodissolve, Lipo Lab, Kabelline, … 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

Posted 10 Jan 2024

A small, but well-conducted, study of the effect of CBD oil on bad toothaches neither proves nor disproves whether the drug works. However, some intriguing data could be confirmed in a larger clinical trial. Let’s call this mildly encouraging. At best.

I’m always skeptical of claims concerning therapeutic uses of CBD oil (cannabidiol) and also the results of clinical trials that contain a small number of participants. So when I came across a 2023 paper in the Journal of Dental Research (peer-reviewed) about a clinical trial with 61 participants that examined whether CBD could be used to treat toothache pain, I was tempted to ignore it. But the trial by the Rutgers School of Dental Medicine should not be ignored; it was a double-blinded placebo-controlled randomized clinical trial (RCT) with two different doses

Read the rest

Australian TGA seizes hundreds of potentially dangerous sport supplements from Sydney retail store

Posted 10 Jan 2024

The Therapeutic Goods Administration (TGA) with the assistance of NSW Police have seized 478 sport supplements containing potentially dangerous substances from a Sydney retail store.

It is alleged that the supplements were intended for supply to consumers. Some of the supplements are alleged to contain substances which are banned from sale and supply in Australia due to their high risk to consumer health.

The seizures were made after the TGA and NSW Police executed search warrants at the Sydney retail store on 19 December 2023 as part of ongoing investigations into the alleged importation, manufacture, supply, and advertising of unapproved therapeutic goods.

In Australia, medicines and chemicals are classified into schedules in the Poisons Standard according to the level of regulatory control required to protect public health and safety. Schedule 4 lists substances regulated as prescription-only medicines and schedule 10 lists substances of such danger to … Read the rest

Do testosterone boosters work?

Posted 20 December 2020

And can they help men improve their mental and physical health?

From Skeptical Inquirer 5 Dec 2023

Extract:

There are hundreds, if not thousands, of commercial products aimed at increasing testosterone; they represent a drop in an ocean that is swelling with some 30,000 dietary supplements. The ones offered for boosting testosterone range from relatively benign multivitamins to anabolic/androgenic steroids and everything in between, all thriving in an industry lacking effective regulation or validation of claims.

When evaluated, the evidence is found wanting. Of fifty commercial products claiming to boost testosterone, improve libido, or help men feel stronger, only around 25 percent were supported by any evidence. Around 62 percent of supplements had no literature whatsoever, which is a surprise given the 109 unique compounds found among the supplements (an average of 8.3 ingredients per product). With such a litany of ingredients, one would expect … Read the rest

Natural remedies might not be better – so why do we still prefer them?

Posted 28 Nov 2023

People are more likely to reach for what’s ‘natural’ when treating a psychological condition, a study found – because they don’t want to affect their ‘true self’

The Guardian

Shayla Love Mon 13 Nov 2023 17.00 GMT

Let’s say that one day, you wake up incredibly itchy. A doctor recommends two drugs – one natural and one synthetic – to help with the scratching. Or, you start having intense mood swings, and you go to your doctor, who presents you with the option of taking a natural or a synthetic drug.

Which do you pick in each situation, and does the answer change if you’re treating your body as opposed to your mind?

We are bombarded with the word “natural” anytime we buy groceries, supplements, beauty products, household items, wine or cigarettes. People believe that “natural” products, foods and medicines are safer, healthier – and just … Read the rest