By Jana Bounds
You’ve probably heard of third-party testing regarding supplements, but have you ever wondered if it matters? The short answer: it absolutely does.
Third-party testing serves as the bridge between antiquated and flawed legislation that limits Food and Drug Administration (FDA) regulatory power and a lucrative supplement industry swimming with dangerous products.
Few Americans can forget the Ephedra scandal of the early 2000’s. The diet pills that were available over the counter were linked to heart attacks, strokes, and 155 deaths.
Baltimore Orioles pitcher Steve Bechler’s Ephedra-linked collapse and death at spring training brought the issue into the spotlight and led to an FDA ban on Ephedra.
But the story of dangerous supplements doesn’t end there. In fact, it doesn’t end at all.
After Ephedra was removed from the market, a synthetic substitute surfaced. Called DMAA, lab testing revealed its effect on the human body is at par with cocaine and methamphetamines, increasing the risk of heart attack and a number of other health issues. Although the FDA declared DMAA illegal for supplement use in 2013, a 2018 press release noted the administration “continues working on getting DMAA products off the market when it identifies them.” This hints that DMAA continues to taint products sold in America.
Despite the Ephedra mortalities taking place over 20 years ago and a host of supplement-caused hospital visits and hospitalizations since, dangerous substances remain very much a part of the global dietary supplement industry, projected to be worth $350 Billion by 2032.
The alarm bell has been sounding for years: by individual physicians who have seen their patients hospitalized by tainted supplements, by research institutes, the American Medical Association (AMA), and by some Senators who recently started pushing for legislative reform for greater regulation.
Eighty thousand new dietary supplement products have been introduced in the United States since 1994.
This data is representative of a steady cadence of new products and ingredients entering the market and bodies of American citizens—and with little oversight.
The fast pace with which new dietary supplements are introduced, and the fact that FDA approval is not required before products enter the market, make third-party testing essential.
The Health Crisis Caused by Supplements
Ask anyone taking dietary supplements why they’re taking them, and the answer will almost always be for health. Many never suspect that the very product labeled as healthy could be killing them or causing permanent damage to their bodies.
It is a problem exacerbated by the complex global supply chain, the internet, and newly unearthed ingredients with undetermined safety, according to the AMA.
Not only is FDA power limited by legislation like the 1994 Dietary Supplement Health and Education Act (more on this below), but it also has difficulty keeping up with the volume of products that enter the market—and so many don’t comply with FDA criteria before being sold. The FDA has only received acceptable safety data for fewer than 250 new ingredients since 1994, according to the AMA.
As a result, contaminated or subpar dietary supplements often reach consumers.
A California Department of Public Health study identified over 750 supplement brands that have been found to be tainted with hidden (and harmful) prescription drug ingredients in the last decade. Only half of those have been recalled by the FDA—and the ones that remain have the potential to cause serious health problems.
The numbers speak to the exceptional safety risks to most of the U.S. population: 77% of Americans take dietary supplements; meanwhile, a 2015 study discovered that dietary supplements are tied to 23,000 emergency room visits and 2,000 hospitalizations in the U.S. annually.
What Prompted the Supplement Safety Issue?
“It’s a Sherlock Holmes situation,” Dr. Pieter Cohen told Science.org of when he begins tracking a dangerous substance in a supplement. “There’s a crime scene, there’s hints of struggle, people are dying after taking supplements... What is actually going on?”
Everything about the US dietary supplement industry changed in 1994, with the adoption of The Dietary Supplement Health and Education Act (DSHEA), which reshaped the industry in many ways:
Where the act expanded consumer choice and increased options, it also laid the framework for trouble, including lack of safety regulations, inadequate post-market monitoring, greater potential for misleading health claims, inconsistent quality control, and limited FDA authority to regulate supplements similarly to pharmaceutical drugs.
Critics of the legislation believe the FDA should harbor more power to enforce safety standards, conduct inspections, and efficiently remove dangerous or non-compliant products from the market.
A Crusade Determined to Save Lives
If the FDA is fumbling in the dark regarding the vitamin and dietary supplement industry, then how is the public even learning about the bad supplements on store shelves?
Well, it’s a sort of global grassroots effort; a consortium of experts including Dr. Cohen, whom a Science.org article refers to as a combination of Indiana Jones and Sherlock Holmes for the supplement world.
“With chemist colleagues in the United States, Brazil, and Europe, he hunts for drugs illegally buried in supplements. Then he goes public,” according to the article.
Cohen worked with Brazilian immigrant patients who came down with mysterious symptoms like kidney failure and heart palpitations, sweating, and anxiety with simultaneous exhaustion. The common denominator between all ill patients? Rainbow diet pills from Brazil. He sent some of the supplements off for testing and the results were appalling.
Tests showed that the pills contained amphetamines, thyroid hormones, numerous diuretics, benzodiazepines, and antidepressants. Wanting to get the word out, Cohen called NPR.
After his interview, he was contacted by a number of industry experts warning him about similarly hazardous supplements being sold in the United States.
Amy Eichner of the U.S. Anti-Doping Agency in Colorado Springs, Colorado and Patricia Deuster at the Uniformed Services University of the Health Sciences in Bethesda, Maryland, concerned about contaminated dietary supplement use by professional athletes and soldiers, teamed up to systematically review commonly used performance supplements.
Their findings, shared with Science.org, confirmed the need for concern: many of the products they tested for bodybuilding, weight loss, and athletic performance contained either Schedule III substances (categorized with things like anabolic steroids and ketamine) on the Controlled Substances Act or were already declared illegal by the FDA.
What Can Be Done?
Where medical professionals are turning to journals and journalists to help get the word out regarding unsafe dietary supplements, some lawmakers are equally alarmed and attempting to change the status quo.
2022 Bipartisan legislation sponsored by U.S. Senate Majority Whip Dick Durbin (D-IL) and Senator Mike Braun (R-IN) to amend The Dietary Supplement Health and Education Act (DSHEA) highlights mounting attention to the issue, even though the bill died in committee.
“Many people assume that if a product is sold in the United States of America, somebody has inspected it and it must be safe. Unfortunately, that’s not always true,” Durbin stated in an April 2022 press release. “Our bill will give the FDA the information it needs to protect Americans from dangerous products being sold as health supplements. Our bill will give them the information and the power.”
He urged his colleagues to pass it, citing the bill as a commonsense, bipartisan compromise that would protect consumer health and save lives.
However, some industry experts argued that the bill was akin to requiring premarket approval by the FDA, and critics became many and varied. Critics particularly included manufacturers and consumers of products which include ingredients that are currently not regarded by the FDA as legal dietary ingredients, although the industry believes differently. These include products like hemp cannabidiol (CBD) and N-acetyl-L-cysteine (NAC), which are both stuck in “legal and regulatory quagmire.”
How Consumers Can Keep Themselves Safe
While the efforts of trailblazing physicians, researchers, and lawmakers are notable, the onus remains squarely on the shoulders of consumers to ensure the products they are ingesting are safe.
And the best way to do that is by making sure your dietary supplements are third-party (3rd-party) tested.
How Third-Party Testing Works and Why it Matters
Third-party testing refers to the independent evaluation of dietary supplements by an external laboratory or testing facility to assess their quality, purity, and safety. It matters with dietary supplements because it provides unbiased verification of product claims, ensures adherence to quality standards, and helps consumers make informed decisions about the supplements they choose to use.
Most companies that have gone the extra mile for consumer safety and trust will proudly display a “third-party tested” or “3rd-party tested” stamp on their product labels. Look for it, and if you don’t see it then do a google search to seek confirmation, or even contact the company directly. You have a right to know what you’re taking is safe and contains the ingredients companies claim.
How does Current Good Manufacturing Practice (cGMP) Fit into Supplement Safety?
cGMP refers to a set of regulations and guidelines established by the FDA. The FDA requires that all dietary supplements be manufactured in compliance with standards that cover various aspects of manufacturing, including personnel, facilities, equipment, documentation, production, quality control, and more. Ideally, this would protect consumers by ensuring quality, safety, and proper labeling.
However, manufacturers may not adhere to cGMP regulations for several reasons despite the requirement, which could include oversight, non-compliance, or intentional disregard of regulations.
Again, the FDA's woeful lack of resources for inspections and enforcement are highlighted: substandard and unsafe products can be sold in stores long before those manufacturers are inspected or audited for cGMP compliance.
This is where 3rd Party Verification of cGMP compliance becomes worth its weight in gold (well, safety).
Many in the supplements and vitamins industry recognize the FDA lacks the resources to ensure the safety and quality of vitamin and supplement manufacturing.
Some companies elect to go the extra mile and decide to get third-party verification of cGMP compliance. Third-party verifications of cGMP compliance refer to assessments conducted by independent organizations or agencies to confirm that a manufacturer or facility meets the required standards and regulations.
Third-party verification of cGMP is done voluntarily and to provide additional confidence to consumers and stakeholders about a manufacturer's commitment to quality, safety, and regulatory compliance.
Here are a few examples of third-party verifications commonly used to validate cGMP compliance:
NSF International Dietary Supplement Certification: NSF International is an independent organization that offers certification services for dietary supplements. Their certification program verifies compliance with cGMP requirements, including facility audits, product testing, and ongoing monitoring. Manufacturers that receive this certification have demonstrated their commitment to quality and regulatory compliance.
UL (Underwriters Laboratories) Certification: UL is a global safety science company that provides various certifications, including cGMP verification for dietary supplements. UL conducts audits and assessments to ensure compliance with cGMP regulations and helps manufacturers meet quality and safety standards.
USP Verified Mark: The United States Pharmacopeia (USP) is a nonprofit organization that establishes quality standards for medicines, dietary supplements, and related products. USP offers a verification program where manufacturers can voluntarily submit their products for testing and assessment against USP's standards, including cGMP compliance. Products that meet the requirements receive the USP Verified Mark.
ISO 9001 Certification: Although not specific to cGMP compliance, ISO 9001 certification signifies adherence to quality management principles. ISO 9001 certification involves an independent assessment of a manufacturer's quality management systems, which can include compliance with cGMP requirements.
Learn More About Third Party Testing of Supplements
Visit Health By Principle to find GMP-compliant nutritional supplements produced in an NSF registered laboratory. Health By Principle supplements are independently verified.
When considering dietary supplements, consumers can look for products that carry these verifications or certifications as an indication of the manufacturer's efforts to provide quality, safe vitamins and supplements.