By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Health Works CollectiveHealth Works CollectiveHealth Works Collective
  • Health
    • Mental Health
    Health
    Healthcare organizations are operating on slimmer profit margins than ever. One report in August showed that they are even lower than the beginning of the…
    Show More
    Top News
    stress management for healthcare workers
    3 Tips For Healthcare Professionals: How To Stay Beautiful, Healthy, and Happy
    November 2, 2021
    importance of relaxing on the weekend for your health
    Importance of Relaxing During the Weekend for Optimal Health
    March 25, 2022
    LASIK Eye Surgery
    What Is LASIK Eye Surgery?
    May 16, 2022
    Latest News
    6 Easy Healthcare Ways to Sit Less and Move More Every Day
    September 10, 2025
    7 Most Common Healthcare Accreditation Programs: Which Should You Use?
    August 20, 2025
    Hospital Pest Control and the Fight Against Superbugs
    August 20, 2025
    Hygiene Beyond The Clinic: Attention To Overlooked Non-Clinical Spaces
    August 13, 2025
  • Policy and Law
    • Global Healthcare
    • Medical Ethics
    Policy and Law
    Get the latest updates about Insurance policies and Laws in the Healthcare industry for different geographical locations.
    Show More
    Top News
    Heroism in Harm’s Way
    February 21, 2015
    5 Things Every Trainee GP Should Know
    August 27, 2019
    Top 5 Facts About CPPA Accreditation
    April 9, 2015
    Latest News
    Healthcare at a Crossroads: Why Leadership Matters More Than Ever
    September 9, 2025
    How Social Security Disability Shapes Access to Care and Everyday Health
    August 22, 2025
    How a DUI Lawyer Can Help When Your Future Health Feels Uncertain
    August 22, 2025
    How One Fall Can Lead to a Long Road of Medical Complications
    August 22, 2025
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: Is Generally Regarded as Safe (GRAS) safe enough?
Share
Notification Show More
Font ResizerAa
Health Works CollectiveHealth Works Collective
Font ResizerAa
Search
Follow US
  • About
  • Contact
  • Privacy
© 2023 HealthWorks Collective. All Rights Reserved.
Health Works Collective > Wellness > Is Generally Regarded as Safe (GRAS) safe enough?
Wellness

Is Generally Regarded as Safe (GRAS) safe enough?

DavidEWilliams
DavidEWilliams
Share
5 Min Read
SHARE
ID-10072764

What did I eat?

ID-10072764

What did I eat?

Unlike most people exposed to the Frontline investigation of supplements and vitamins, I really didn’t find it shocking that a lot of supplements are dangerous and that the bottles don’t contain what they say they do. I feel sorry for people who take these products and are not helped –and are even harmed– but frankly the customers should know better.

The story got me thinking about a related topic: the safety (or lack thereof) of food additives. An NPR story from last year (Why the FDA has never looked at some of the additives in our food) sums it up well:

Companies have added thousands of ingredients to foods with little to no government oversight. That’s thanks to a loophole in a decades-old law that allows them to deem an additive to be “generally recognized as safe” — or GRAS — without the U.S. Food and Drug Administration’s blessing, or even its knowledge.

The loophole was originally intended to allow manufacturers of common ingredients like vinegar and table salt — when added to processed foods — to bypass the FDA’s lengthy safety-review process. But over time, companies have found that it’s far more efficient to take advantage of the exemption to get their products on shelves quickly. Some of these products contain additives that the FDA has found to pose dangers. And even ingredients the agency has agreed are GRAS are now drawing scrutiny from scientists and consumer groups that dispute their safety.

Basically companies have been declaring their own products as GRAS. Sometimes they let the FDA know and sometimes not. Since the GRAS concept was introduced during the Eisenhower administration the number of additives in food has gone from around 800 to over 10,000. Chances are you eat GRAS substances every day.

The FDA review process for food is cumbersome, which is a deterrent to undertaking it. But some safety testing is becoming radically less expensive and more reliable. One area I know about is cardiac safety, thanks to my role on the iCardiac Technologies board. Until recently, drugs in development were assessed for cardiac safety by a highly manual and expensive process of measuring QT prolongation. Now iCardiac’s Early Precision QT approach can provide definitive results with a much smaller and more affordable study and it is becoming the standard that is endorsed by FDA and international bodies.

So with the new approach, maybe it’s time to reconsider the cost/benefit of cardiac safety testing at least for certain food additives.

FDA’s “threshold of concern” is reached when a drug extends the QT interval by 10 milliseconds (ms). As it turns out, some food ingredients can reach or exceed this level. For example:

  • An American Heart Association study found that energy drinks could boost QT by 10 ms.
  • Licorice (also used as a sweetener in some products) can lead to long QT when “abused”
  • Ginseng can increase QT by 15 ms.

Some of the more responsible companies like Cargill are undertaking safety studies for new products. Cargill has been evaluating a new sweetener (3000x as sweet as fructose!) derived from root bark. After some initial concerns were unearthed, the company conducted a QT study to determine the ingredient’s safety. As it turned out, this ingredient was found to cause a 20+ ms prolongation of the QT interval, which will certainly give Cargill pause before continuing development. Results of the study (Detection of ECG effects of (2R,4R)-monatin, a sweet flavored isomer of a component first identified in the root bark of the Sclerochitin ilicifolius plant) have been published in Food and Chemical Toxicology.

With new techniques, you don’t have to be Cargill to be able to afford to test food ingredients for safety. As consumers become more discerning it will become a good business decision to test more thorougly.

Image courtesy of David Castillo Dominici at FreeDigitalPhotos.ne

—

By healthcare business consultant David E. Williams, president of Health Business Group.

 

TAGGED:cardiac safetyFDAfoodGRAS
Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

a woman walking on the hallway
6 Easy Healthcare Ways to Sit Less and Move More Every Day
Health
September 9, 2025
Clinical Expertise
Healthcare at a Crossroads: Why Leadership Matters More Than Ever
Global Healthcare
September 9, 2025
travel nurse in north carolina
Balancing Speed and Scope: Choosing the Nursing Degree That Fits Your Goals
Nursing
September 1, 2025
intimacy
How to Keep Intimacy Comfortable as You Age
Relationship and Lifestyle Senior Care
September 1, 2025

You Might also Like

cardio and muscle building are both important
Wellness

4 Effective Cardio Workouts to Help You Shed Extra Weight

October 24, 2022
SpecialtiesWellness

4 Tips For Conquering Insomnia During Addiction Recovery

March 9, 2019
pharmaphorum
Medical EducationSocial MediaWellness

Pharma Is from Mars, Patients Are from Venus

April 2, 2015

DC Conference: FDA At A Crossroads

November 8, 2011
Subscribe
Subscribe to our newsletter to get our newest articles instantly!
Follow US
© 2008-2025 HealthWorks Collective. All Rights Reserved.
  • About
  • Contact
  • Privacy
Welcome Back!

Sign in to your account

Username or Email Address
Password

Lost your password?