Month: April 2019

Study: Risky Stimulants Still in Many Supplements

Post author By admin
Post date April 10, 2019
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By Alan Mozes

HealthDay Reporter

MONDAY, Oct. 22, 2018 (HealthDay News) — The U.S. Drug and Food Administration has repeatedly warned manufacturers that many dietary supplements contain dangerous, experimental stimulants. But according to a new report, 75 percent of supplements tested still contain the compounds.

“Consumers turn to supplements for safe, natural ways to increase energy, improve workouts or lose weight,” said study author Dr. Pieter Cohen, an associate professor with Harvard Medical School. “[But] what most consumers don’t know is that supplements can be sold as if they give you energy, help you lose weight or just about anything, as long as the supplement does not claim to cure or treat disease.”

His team’s findings centered on four unapproved stimulants: DMAA, DMBA, BMPEA and oxilofrine.

The four have become replacements for the stimulant ephedra, which the FDA banned from supplements in 2004 following reports that it raised the risk for heart attack, stroke and death.

Between 2013 and 2016, the FDA found that 12 different supplement brands contained one or more of the four unapproved stimulants. But despite public notice warnings from the agency, three-quarters of the supplements still contained at least one prohibited stimulant in 2017. And half contained two or more.

The finding raises fresh concerns about supplement safety, and comes on the heels of another troubling analysis published just last week by the California Department of Public Health’s Food and Drug Branch.

That investigation revealed that the FDA had issued more than 700 warnings over the last decade about potentially hazardous ingredients found in supplements promoted as sexual, weight-loss and muscle growth aids.

But because the FDA classifies dietary supplements as a food — rather than as drugs — supplement manufacturers do not have to prove a supplement is safe or effective before selling it to the public.

If, however, the FDA ultimately determines that a supplement already on the market is potentially hazardous, it can recall the product or issue a “public notice” concerning problematic ingredients.

In a letter published online Oct. 22 in the journal JAMA Internal Medicine, Cohen and his colleagues point to an earlier study that suggests that FDA recalls, for one, are largely ineffective.

Continued

The latest investigation focused on the effectiveness of public notice warnings, and found equally poor results.

“The FDA seems to imagine that if they simply request that firms remove an experimental stimulant from commerce, the stimulant will be removed,” Cohen said. “Clearly this is wishful thinking on the part of the FDA.”

Cohen noted that he and his associates conducted two analyses of 12 supplements previously issued public notices for unapproved ingredients.

The first analysis took place in 2014. At that time, all 12 supplements contained at least one of the four prohibited stimulants.

The second analysis took place in 2017. At that point, nine of the 12 brands contained at least one prohibited supplement and six contained two.

The team also pointed out that although DMBA had not been found in any of the 12 supplements in 2014, it was found in a third of the supplements in 2017, two years after the FDA issued a public notice raising concern about the ingredient.

“Until the law is reformed and the FDA aggressively enforces the law, these potentially dangerous ingredients will likely remain in supplements,” said Cohen.

Dr. Mitchell Katz is president and CEO of NYC Health and Hospitals in New York City, and author of an accompanying editorial. He suggested that the upshot is that the FDA is hamstrung in what it can do.

“The FDA is not allowed by federal law to investigate a product before it is marketed,” Katz noted. “Therefore, all that the FDA can do under current law is respond to complaints and issue guidelines of what can and cannot be in supplements.”

The bottom line, said Katz, is that “people should know that the supplements they are taking are not tested [and] may contain substances that are not on the label.”

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Weight Loss Products

Uncertainty over Garcinia’s weight-loss claims

Post author By admin
Post date April 9, 2019
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DOES IT WORK?Further studies needed to determine effects, writes DÓNAL O’MATHÚNA

GARCINIA SPECIES are widely used in Thai and Indian cuisine. The fruit, especially from Garcinia cambogia, has developed a reputation among those seeking to lose weight and build muscle.

Extracts of the fruit contain up to 50 per cent hydroxycitric acid, which is believed to be the active ingredient.

Earlier this year, the Food Safety Authority of Ireland (FSAI) issued a product alert, calling on consumers to discontinue using all “Hydroxycut’’ products.

The product name comes from hydroxycitric acid, which is added to some of the products in the form of Garcinia cambogia. The FSAI called on retailers not to sell these products, but they can still be found on Irish websites and remain available elsewhere.

The FSAI alert is based on recent case reports suggesting a link between Hydroxycut products and liver damage. The Canadian manufacturer voluntarily withdrew its products from the US market after the Food and Drug Administration (FDA) issued a consumer warning.

The weight-loss properties of hydroxycitric acid have been studied since the 1960s. Laboratory tests have shown that it inhibits an enzyme involved in producing body fat from other foods. Research also suggested that hydroxycitric acid may suppress appetite and reduce food intake in animals.

These results led to a series of small human studies in the early 1990s which produced contradictory results. One of the largest randomised controlled trials of hydroxycitric acid to date was published in 1998.

More than 130 overweight men and women took either 1.5g hydroxycitric acid (3g Garcinia cambogia) daily or placebo while also eating a high-fibre, low-calorie diet. Both groups lost weight during the study, but the two groups did not differ in the amount of weight lost or their body fat. Some have claimed that the diet may have interfered with the effects of the Garcinia.

At this point, close to a dozen randomised controlled trials have been conducted with Garcinia, although some of them have used it in combination with other herbs. Some of the studies have produced positive effects, although the quality of the research was sometimes poor.

The safety of hydroxycitric acid has been evaluated in recent studies, in addition to the long traditional use of Garcinia. In general, the herb and food supplements have not produced adverse effects and are generally regarded as safe at recommended doses.

Then several case reports were published in the medical literature of liver damage following consumption of Hydroxycut products. In 2009, the FDA reported that it had received 23 cases of serious health effects from these products.

The damage ranged from jaundice to liver failure requiring transplantation and one death. Although the number of cases is low, their seriousness led to the consumer alerts mentioned above and subsequent product withdrawals.

Determining the precise cause of the liver damage is difficult. Hydroxycut contains a number of herbs and other agents, with different mixtures used in different products. Some formulations do not contain any Garcinia cambogia.

The case reports have not been able to identify which ingredient, or combination of ingredients, may have led to the liver damage.

Further research is needed to understand the precise source of these problems.

Hydroxycitric acid from Garcinia cambogia shows some potential as a weight-loss product. However, the available studies are variable in their quality and the types of products tested. More studies are needed to demonstrate whether or not the products are effective and safe.

The reports of potential liver damage associated with Hydroxycut products point to the need for careful evaluation and monitoring of all herbal remedies.

When products contain several herbs, the precise source of positive or negative effects is difficult to determine. Given this uncertainty, and the complexity of weight loss, people should rely on the standard, proven methods of weight loss: reduce calorie intake, increase physical activity and find others to support your efforts.

While some supplements may be helpful, Hydroxycut should be avoided.

Dónal O’Mathúna has a PhD in pharmacy, researching herbal remedies, and an MA in bioethics, and is a senior lecturer in the School of Nursing, Dublin City University. He is author of Alternative Medicine: The Christian Handbook, Updated and Expanded Edition, Zondervan, 2007

Tags Garcinia cambogia

Weight Loss Products

Dr. Oz dietary supplements under investigation

Post author By admin
Post date April 9, 2019
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