Connect with us

Supplements

Can Supplements Have Harmful Side Effects? – MedShadow

Published

on



An analysis of supplement adverse events found that less than 1% of them were serious in nature. The research, which was sponsored by an industry trade group, comes despite a 2015 study that found more than 20,000 emergency visits each year are due to supplement adverse events and indications the true number of events are under-reported.

Researchers examined 41,000 adverse event reports related to supplements made by two manufacturers. The study was conducted by Supplement Safety Solutions, a safety consulting firm to the supplement industry, and the Council for Responsible Nutrition. The latter is a trade association and lobbying group for supplement manufacturers.

Results, published in the Journal of Dietary Supplements, found 0.48% of the adverse events were considered serious. More than two-thirds of those serious adverse events were in supplements marketed for weight loss. About 20% were for products purporting to help with glycemic (sugar) control.

The most common symptoms associated with the serious adverse events were dehydration, dizziness, headache, nausea and vomiting.

A 2018 study analyzing adverse events from supplements reported to the <span data-cmtooltip="The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.” class=”glossaryLink “>FDA over a 10-year period found serious outcomes included deaths, hospitalizations, life-threatening conditions and birth defects. It also estimated that the dietary supplement adverse event reporting rate is only about 2%.

Average: 0
Jonathan Block
Jonathan Block

Jonathan Block is MedShadow’s content editor. He has previously worked for Psychiatry Advisor, Modern Healthcare, Health Reform Week and The Pink Sheet.

Let’s block ads! (Why?)



Source link

Supplements

"You're Just Peeing Out a Lot of Money." This Is the Real Way You're Flushing Your Retirement Savings Down the Drain – MONEY

Published

on

By


| Money

this link is to an external site that may or may not meet accessibility guidelines.

Let’s block ads! (Why?)



Source link

Continue Reading

Supplements

FDA Sends Warning Letters on Dietary Supplements – Wall Street Journal

Published

on

By


The FDA has sent warning letters to companies marketing dietary supplements.


Photo:

Jacquelyn Martin/Associated Press

The U.S. Food and Drug Administration said it sent warning letters to 11 companies for marketing dietary supplements that don’t meet its guidelines.

The agency issued warnings to three companies for marketing dietary supplements containing phenibut, which is sometimes sold as a sleep aid or to treat anxiety. It said that phenibut doesn’t meet the statutory definition of a dietary ingredient, which is generally a vitamin, herb or other natural substance used to supplement the diet. 

A Wall Street Journal article last week on the $40 billion supplement industry said that phenibut, developed as a drug in the former Soviet Union, was being marketed as a “nootropic,” or brain supplement, in the U.S. A spokeswoman for the FDA said that the agency was already investigating phenibut.

The FDA also issued warnings to eight companies for marketing dietary supplements containing DMHA, a stimulant sometimes found in exercise and weight-loss supplements. The companies have 15 business days to inform the FDA of steps they will take to bring their products into compliance. That could include a decision to recall, reformulate or discontinue sales.

Supplements aren’t tightly regulated by the FDA like prescription drugs. Dietary-supplement manufacturers don’t need approval from the FDA before introducing their products to the market. The FDA has oversight for taking action against any misbranded supplement after it reaches the market.

The FDA said it is launching a new online tool to help warn consumers of ingredients that appear to be unlawfully marketed in supplements. The agency said the Dietary Supplement Ingredient Advisory List will help get cautionary information to the public more quickly before it issues any final determination. It is on the FDA website, and consumers can also sign up to receive updates and changes to the list.

Write to Anne Marie Chaker at anne-marie.chaker@wsj.com

Let’s block ads! (Why?)



Source link

Continue Reading

Supplements

New Tool Alerts Public to Unlawfully Marketed Dietary Supplement Ingredients – The Cardiology Advisor

Published

on

By


In an effort to better alert the public of unlawful ingredients in dietary supplements, the Food and Drug Administration (FDA) has created the Dietary Supplement Ingredient Advisory List, a new reference tool for consumers and manufacturers.

Available on the FDA website, the list includes ingredients that may not lawfully be included in dietary supplements. Consumers may wish to avoid supplements that include these ingredients as they may not fit the definition of a dietary ingredient or may require pre-market notification that was not submitted; inclusion in this list does not necessarily mean the ingredient poses a safety concern.

“It is important to note that the List is not exhaustive; it will always be a work in progress,” said Frank Yiannas, the FDA’s Deputy Commissioner for Food Policy and Response. “We expect the List will evolve as new ingredients are identified and others are removed.” In addition, the FDA will continue to communicate with the public regarding any safety concerns identified with new dietary supplement ingredients.

In a press statement, Yiannas also noted that the agency recently sent out warning letters to 8 companies that were marketing dietary supplements containing DMHA and 3 companies marketing supplements with phenibut; neither one of these currently meets the FDA’s definition of a lawful dietary ingredient. “We take these violations very seriously and stand ready to take enforcement action without further notice if the companies do not immediately cease distribution of the products,” said Yiannas. In February 2019, the FDA went after 17 companies selling unapproved and/or misbranded products (most sold as dietary supplements) claiming to prevent, treat, or cure Alzheimer disease and other serious disease and health conditions.

Consumers who wish to receive alerts related to updates to the Dietary Supplement Ingredient Advisory List can sign up here.

For more information visit FDA.gov.

Related Articles

This article originally appeared on MPR

Let’s block ads! (Why?)



Source link

Continue Reading

Trending