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Scooped by Seth Bilazarian, MD

How Can We Know if Supplements Are Safe if We Do Not Know What Is in Them?

How Can We Know if Supplements Are Safe if We Do Not Know What Is in Them? | Heart and Vascular Health | Scoop.it

Americans spend over $20 billion annually on dietary supplements.1 Although supplements are regulated by the US Food and Drug Administration (FDA) under the Dietary Supplement Health and Education Act, there is no requirement for supplement manufacturers to demonstrate efficacy or safety of their products prior to marketing them. However, companies may not include unapproved ingredients. It turns out that even this minimal requirement is not fulfilled. Harel et al identified 237 dietary supplements that were recalled by the FDA owing to inclusion of unapproved drug ingredients. Given the limited regulation of these products, it is likely that the number of recalls grossly underestimates the number of products on sale with unapproved ingredients. Dietary supplements should be treated with the same rigor as pharmaceutical drugs and with the same goal: to protect consumer health.

Seth Bilazarian, MD's insight:

Over 50% of Americans use supplements.  The purity and potency of these supplements is nto closely regulate so the safety of this common practice amongst Americans is questionable at best.  The full NIH report is here http://goo.gl/bUwpy  ;

Steve S Ryan, PhD's curator insight, June 15, 2013 11:01 PM

Steve S Ryan, PhD's insight:        

This is the author's summary from a medical journal article by Mitchell H. Katz, MD.JAMA Intern Med. 2013;173(10):928. doi:10.1001/jamainternmed.2013.415.

The full article is not yet available from Pub/Med.gov. Check this page: http://www.ncbi.nlm.nih.gov/pubmed/23588233


Want to know about about mineral deficiencies in A-Fib patients? Read by article: ‘Natural’ Supplements for a Healthy Heart, at http://a-fib.com/treatments-for-atrial-fibrillation/mineral-deficiencies/supplements-for-healthy-heart/


For my recommended products by brand, see


Dorothy Hale's curator insight, June 16, 2013 8:52 PM

Could supplement makers be unethical by not demonstrating efficacy or saftey prior to hitting retail stores?

Scooped by Seth Bilazarian, MD

Pradaxa (dabigatran) Safety Review of Serious Bleeding Events by FDA

UPDATED 11/02/2012. Results of FDAs Mini-Sentinel assessment indicate that bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin.
My comment -= I hope this review by the FDA reassures patients that the use of Pradaxa is safe as an alternative to warfarin,. This adds to the randomized trial RE-L. Patients are being unnecessarily frightened by TV ads by malpractice attorneys and decisions about options fro treatment are being complicated without reason.,
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Scooped by Seth Bilazarian, MD

FDA Confirms Reports of 13 Deaths Possibly Related to Energy Drink

FDA Confirms Reports of 13 Deaths Possibly Related to Energy Drink | Heart and Vascular Health | Scoop.it

FDA said it has received reports of 13 deaths since 2008 possibly related to the use of 5-hour Energy shots, a disclosure that could heighten scrutiny of drinks and dietary supplements that promise to deliver an energy..

5-hour Energy, sold in 1.93-ounce plastic bottles, increasingly has become a fixture at check-out counters of convenience stores and drug stores. Its label promises to deliver a boost of energy "in minutes."

In a statement Wednesday, Living Essentials said 5-hour is intended for "busy adults" and that its product is an effective dietary supplement, containing about as much caffeine as a cup of coffee.

It recommends on product labels that consumers don't drink more than two bottles a day, spaced several hours apart, and that consumers sensitive to caffeine should consult with a physician.

"It is important to note that submitting a serious adverse event report to the FDA, according to the agency itself, is not construed by FDA as an admission that the dietary supplement was involved, caused or contributed to the adverse event being reported, or that any person included in the report caused or contributed to the event," the company added in its statement Wednesday.

Living Essentials had about $600 million in sales last year.

Supplements's curator insight, November 6, 2013 12:12 AM

God has not made everyone equal, some of them has been gifted with a decent physique but some are not. All those unfortunate ones struggle hard to increase their body weight and at times feel discouraged. As per physicians there can be two key reasons for it, first not feeling hungry and second fat metabolism for more details: http://www.dietkart.com/health-and-nutrition/weight-management/weight-gain