What are pre-workout supplements?
Pre-workouts have become the rage among gym-goers, athletes, bodybuilders, and trainers. There are a plethora of brands on the market with varying ingredients and dosing recommendations.
Pre-workouts are multi-ingredient dietary formulas meant to be taken 30 minutes before a workout and designed to boost energy and athletic performance.
Most pre-workout supplements are delivered in powder form found in a variety of flavors but are also available in pill form.
Most contain large doses of caffeine ranging from 100 mg to as much as 500 mg per scoop. In addition to the extremely high caffeine content, most pre-workouts contain additional stimulants listed in manufactures “proprietary blends.”
Manufacturers of pre-workout supplements like those that produce energy drinks, vitamins, fat burners and diet pills, are largely unregulated by the U.S. Food and Drug Administration (FDA). As such, they are not burdened by the rigorous research standards required of pharmaceutical drug manufacturers.
*It's important to note these products are not required to be tested for safety and efficacy.
What Are Proprietary Blends?
A proprietary blend is a collection of ingredients often unique to a particular product and sometimes given a special name on a product’s Supplement Facts panel. A proprietary blend might be listed as a “blend,” “complex,” “matrix” or “proprietary formulation.” The specific amount of each individual ingredient in a proprietary blend does not have to be listed; only the total combined amount in the blend must be given. Ingredients in a proprietary blend should, however, be listed in descending order by weight.
The lack of amount for each ingredient is especially important when a proprietary blend contains stimulant (or stimulant-like) ingredients.
Commonly found ingredients in pre-workouts.
Branched chain amino acids (BCAAs)
* dangerous ingredients are frequently being found in adulterated pre-workout supplements.
Read more about adulteration below
Pre-workout Side Effects
A few of the most common pre-workout side effects are:
Tingling/numbness in the face, lips, or extremities
Flushed and red skin
High blood pressure
Increased heart rate
There are serious health risks associated with pre-workout supplements, including:
Caffeine withdrawal symptoms, including headaches
Caffeine overdose, which can be life-threatening
Potential drug/supplement interactions
High blood pressure
Liver damage/ failure
Increases metabolic rate
Sudden cardiac arrest
Why are pre-workout supplements dangerous?
Adulteration and adverse events (AE's) are NOT uncommon in the dietary supplement industry. Energy, weight loss, fat burners, body building and pre-workout supplements are amongst the highest adulterated supplements on the market. Consumers need to be aware many of these products are not clean or safe.
Adulteration of dietary supplements typically involves economic adulteration, in which a less expensive ingredient is used in place of a more expensive ingredient listed on the label, or pharmaceutical adulteration, in which an active drug is included in a purportedly botanical supplement.
By law, dietary supplement manufacturers are responsible for ensuring that their supplement products are safe before they are marketed. Unlike drug products, both in the United States and the European Union there are no provisions in the law to"approve" dietary supplements for safety or effectiveness before they reach the consumer.
Once a product is marketed, the FDA must show that a dietary supplement is "unsafe" before it can take action to restrict a product's use or remove it from the marketplace. Evidence comes largely from reports of adverse events submitted by healthcare providers, consumers, and manufacturers (who must report any serious adverse event). The agency is also tasked with identifying and removing adulterated and hazardous supplements from the marketplace.
There are pharmaceutical-grade products being directly introduced into the supplement marketplace with absolutely no regulatory oversight. Currently, the FDA does not have an effective system to detect supplements that pose serious health risks. Instead, the FDA relies on consumers and physicians to voluntarily submit reports of harm from supplements.
Sadly healthcare providers are NOT required to report adverse events to the FDA. Few consumers or doctors contact the agency or even know the FDA regulates supplements. In recent surveys less than 20% of medical professionals knew how to report an adverse event or death related to dietary supplements. Consumers don't know how or that they should report to the FDA an adverse event or death they believe to be related to dietary supplement. If the FDA is not receiving these types of reports, they don't consider a product a to be a danger or problematic.
The US Government Accountability Office estimates that a small fraction of the estimated 50,000 adverse reactions each year from supplements are reported to the FDA.
Shockingly surveys show less than 1% of these cases ever get reported. The lack of reporting, along with the poor quality of information received in these few reports make it nearly impossible for the FDA to find and remove these dangerous supplements.
In the video below Dr. Pieter Cohen who is a supplement specialist as well as professor at Harvard Medical School and internist at Cambridge Health Alliance talks about the hundreds of adulterated supplements discovered in his testing and points out the ineffective reporting system to detect supplements that pose serious health risks.
Daniel Fabricant who ran the FDA's division of dietary supplement from 2011-2014 states the adverse events reporting system is the same for supplements as it is for pharmaceuticals. All though that may be true, surveys clearly show less than 20% of healthcare professionals know how to report adverse events/deaths related to dietary supplements and less than 1% actually file a adverse event report.
Most consumers trust and believe the product they purchase from large well known retailers must be safe or they wouldn't be on the market. This is simply not true!
Dietary and other nutritional supplements are largely exempt from FDA oversight. Until the Dietary Supplement Health and Education Act of 1994 otherwise known as DSHEA which was written by US Senator Orrin Hatch and Tom Harkin, the FDA held dietary supplements to the standard of pharmaceutical drugs.
Essentially, the law declared vitamins, minerals, and even herbal "remedies" to be dietary supplements. The effect of the law was to remove the pesky FDA from ensuring that the products are safe. Regulations ensure that herbal supplements meet manufacturing standards but don't guarantee that they're safe or effective.
DSHEA also included one very significant grandfather clause stating that any ingredient on the market at the time of the bill's passage would be legal and not subject to FDA review.
The FDA usually takes action if it learns of health and safety problems with products after the fact.
Because the law requires the FDA to prove that products are unsafe and the lack of adverse event reporting, it can take decades to compile sufficient evidence.
In the 1990's, dietary supplements containing ephedra (derived from the Chinese herb ma huang) were widely marketed for boosting energy and weight loss. When combined with caffeine, ephedra does promote modest, short-term weight loss. But it contains chemicals that can constrict blood vessels, and studies linked ephedra use to high blood pressure, palpitations, heart attacks and deaths.
However, because the law required the FDA to prove that ephedra-containing products were unsafe, it took a decade to compile sufficient evidence. During that time, the agency logged 16,000 reports of injuries, 62,000 consumer complaints, and at least 155 deaths related to ephedra-containing products. A national team of researchers revealed that the rate of liver failure from supplements has increased 185% over the past decade.
Although ephedra has been banned and removed from the market, it's still being found in adulterated supplements. Dozens more deadly products containing chemicals and designer stimulants that have never before been tested, have popped up on the market claiming to be legal botanicals such as dimethylamylamine (DMAA). DMAA which is almost molecularly identical to methamphetamine.
DMAA also known by at least 39 other names has killed many people and caused liver failure. After the death of three US soldiers, Private Michael Sparling, Private David Artis and Sargent Dakekia Cola, the US Department of Defense removed all products from the shelves, meanwhile it took the FDA years to remove DMAA and others like it.
Consumers can no longer trust ingredients listed on their supplement labels are safe or factual. Supplements are continuously being found to be adulterated with prescription pharmaceuticals, steroids, stimulants and various other dangerous ingredients. Manufacturers are frequently and purposely submitting FALSE certificates of analysis (COA) and FALSE labeling to the FDA.
In 2017, the US Department of Defense in partnership with the US Anti Doping Agency (USADA) tested over 200 products easily available in the market place.
60.9% tested positive for stimulants not stated on the facts panel label.
49.2% tested positive for steroids.
29.2% tested positive for both steroids & stimulants.
The bottom line is these product can be very dangerous!
There's no way to know what is truly in the the supplements you've purchased unless you pay to have them independently lab tested, which can be quite costly. Time and time again many of these product have proven to be adulterated and have shown to have no real health benefits. Most people would not risk their lives by playing Russian Roulette with a gun, why play it with your supplements?
"Awareness is the first step to action. They have to know something is going on to know to do something about it."
- Derick Virgil