Getting pumped and confused

Hey there, time traveller!
This article was published 21/05/2015 (3256 days ago), so information in it may no longer be current.

First, there was bloating, cramping, stomach pains and, like a form of withdrawal, lethargy. Next came depression, followed by anxiety and the racing heart of an addict on speed.

But this wasn’t from some illicit cocktail of narcotics. It was much more insidious: it was from workout supplements.

The American-made products all had fine print stating their products, or statements outlining their effects, had not been evaluated by the U.S. Food and Drug Administration and were intended for purchase and consumption in the U.S.

It started innocently enough: I’d been recovering from a concussion suffered playing hockey and set out to build my body back after close to three months of almost completely sedentary living. I’d packed on a good 10 pounds of fat, lost a lot of muscle definition and, now a lumpy mess, needed to regain my physique.

Because I’m older than 30, my metabolism would need a bit of help to get over that initial hump. So I did what countless people are doing today — I turned to workout supplements to give me a leg up.

The supplements industry has gone from fringe to mainstream and products normally reserved for gym rats who look like inflated balloons are now commonplace in stores.

But a look inside the realm of supplements produces a picture of confusion. Some are subject to regulation by this or that government agency, others not. And there are a raft of claims, mostly unsubstantiated, or carrying provisos and tell-tale asterisks, about their benefits.

Combining different supplements, particularly without medical supervision, can prove harmful. At least two deaths appear to have some link with their use and athletic exertion.

“The workout-supplement market in Canada does feel a bit like the Wild West, a buyer-beware situation,” said Semone Myrie, an assistant professor at the University of Manitoba’s Human Nutritional Sciences Department. While not a specialist on supplements, her expertise on nutrition and the developmental origins of diseases enables her to point to holes in a field where, instead of clinically educated experts, advice is offered by dietitians and nutritionists with private interests. “Should Health Canada take more of a stand in enforcing the regulations?” Myrie asked. “Absolutely.”

 

My experience

I’d tinkered with supplements throughout my sporting career, but now I’d decided to become a personal lab rat, head to my nearest supplement store and immerse my body full-on.

One of the most popular products I used was Creatine Freak, made by U.S. firm Pharmafreak Technologies Inc. and containing 1,500 mg of concentrated creatine hydrochloride.

Creatine has been the go-to ingredient for years for bodybuilders wanting to add muscle mass quickly. There was a recommended loading phase, a sustainment phase and a cycling-off phase.

Results were dramatic. Creatine Freak helped me gain substantial weight, all of it muscle. Within weeks, I’d turned my body from flab to a hard rock bursting with veins and definition. That provided even more incentive to increase my workouts, and ultimately, my dosage.

However, Creatine Freak came with side effects, though none was listed on the packaging; except instructions that I should consume two to four litres of water a day while using it, which made bathroom trips a nearly constant occurrence. Increased cramping, bloating and stomach pain were the main ills after I’d been on it for a few weeks, well past the loading phase. According to some studies, creatine is said to not only cause body cells to retain water, but also helps produce adenosine triphosphate — the power generator for the body’s muscles. However, beyond giving you a pumped-up look, its benefit is anecdotal at best, and the medical community has reached no consensus on its long-term effects as it hasn’t been on the market for very long.

When I cycled off the supplement, I was fatigued for a week. Lethargic, sloth-like, I assumed my body was adjusting to not having the recommended dose I’d been taking before every weightlifting session. I’d had enough. It felt like going through a cold without the cough and I didn’t want to put my body through that again.

After Creatine Freak, I started taking Pro Line Advanced Nutrition’s BCAA Stack. BCAA refers to branch-chained amino acids and they are probably the second most popular workout supplement behind creatine mixes.

Made in Port Moody, B.C., the product came with hefty claims such as “preventing catabolism,” helping “maintain muscle tissue through sustaining nitrogen balance” and supporting “cell-volumization by increasing nitric oxide levels in the blood.”

The guy who sold it to me, whose muscles were bulging, with veins that resembled garden hoses, spouted off a huge list of benefits. He was neither doctor, nutritionist nor dietitian, but appeared well-versed in how to use BCAAs to my advantage.

The ingredient list was incomprehensible. It included 6,000 mg of 100% Instantized BCAA in a 4:1:1 Ratio, 4,000 mg of Micronized L-Glutamine (USP Grade) and 2,000 mg of L-Citrulline Malate Vitamin Matrix. But the results were indisputable. I gained muscle while cutting weight and found new levels of energy every time I headed to the gym.

However, my mood sank and I became unusually depressed with no reasonable explanation. After some research, I found a few studies that suggested taking BCAAs decreases levels of serotonin — a secretion mainly found in the gastrointestinal tract and believed to contribute to a feeling of well-being.

But no one at the store where it was sold seemed to have a notion of what I was talking about. So I started supplementing BCAAs with 5-HTP and tyrosine, which some believe raise serotonin levels. The mix seemed to do the trick, but I was left shaken, knowing a supplement would leave me depressed and slowly tapered off the supplement.

Finally, I used Carnitine Burn, also made by Pro Line Advanced Nutrition. It was described as “a powerful insulin stabilizer and antioxidant,” that increased “hormone sensitive lipase which shrinks fat cells,” raised serotonin levels in the body and was “clinically shown to dramatically improve nutrient absorption in the body.”

The supplement did exactly what it was supposed to do — burned fat, melting it from my body every time I exercised. But it also left me jumpy, nervous, anxious and with an elevated heart rate. It was impossible to sit still or relax, meaning my motivation to go to the gym increased exponentially. The only way to help wind down was to have a beer or take an over-the-counter painkiller.

The store clerk offered another supplement to offset the Carnitine Burn, but I lacked faith in his medical knowledge to take the leap. So again, much like creatine and BCAAs, with no consensus from the medical community on the effects of this supplement, I was forced to tinker with my own body.

Meanwhile, Edmonton ophthalmologist Andrew Machuk was in a similar state. A relatively fit former college baseball and tennis player who had put workouts on the backburner, he decided in January it was time to shed some pounds. He opted for supplements, combined with a low-sugar and low-carbohydrate diet and a three-times-a-week exercise regime.

He started taking pre-workout N.O.-Xplode, multivitamins and BCAAs twice a day with meals.

N.O.-Xplode, manufactured by American workout supplements company BSN, is made up of a list of ingredients, some trademarked, that are inexplicable to nearly the entire population: Astragalus membranaceus Extract, Beta-Alanine HCl, Creatine Peptides, Hydrolyzed Whey Protein Isolate. He also began taking BSN’s Hyper Shred. The ingredients included Thermodynamic Interfusion, Caffeine Anhydrous, Bitter Orange Extract and Cyanocobalamin.

While the product labelling might as well have been written in hieroglyphics, the outcome was pretty straightforward.

“The results were dramatic,” said Machuk. “Over the course of the first six weeks I lost 10 pounds while maintaining or exceeding my previous weight maximums. Not only did I hit my weight loss goals successfully, but my energy and mood was up and food cravings decreased between meals.”

After six weeks, Machuk tapered off the supplements, and has since been able to maintain a lower, healthier weight with few side effects.

Though hardly a supplements expert, Machuk’s knowledge of the human body and the effect workout products can have on it enable him to safely experiment with various supplements. A layperson unable to distinguish between creatine and creatine monohydrate, or the inner workings of metabolic functions, is probably guessing, at best.

“Health Canada states that manufacturers are allowed to make claims providing they are supported by scientific evidence. However, who is checking the validity of these claims relative to the science?”
— Semone Myrie, University of Manitoba

All the products Machuk and I used had similar themes: the American-made products all had fine print stating their products, or statements outlining their effects, had not been evaluated by the U.S. Food and Drug Administration and were intended for purchase and consumption in the U.S.

The Canadian-made products contained neither a mention of Health Canada — our federal department responsible for public health — nor a Health Canada Natural Health Product number (an “NPN” on the product), nor an evaluation by the FDA despite being available for online purchase in the United States.

Each label was littered with asterisks, explaining the daily value of many of the ingredients had not been established, that a physician should be consulted before consuming, and, in the case of N.O.-Xplode, the product should not be taken if you’re “sensitive to Beta-Alanine, caffeine or niacine.” Potential users were told not to “consume caffeine from other sources” to avoid nervousness, irritability, sleeplessness, and occasionally rapid heartbeat.

 

Regulatory landscape

Like the ingredients, the regulatory landscape for workout supplements is confusing and perplexing. The increasingly intense spotlight placed on vitamins and minerals has yet to hit such proMducts with flashy names such as MuscleTech Hydroxycut Hardcore Elite, Arnold Schwarzenegger Series Iron Whey and Mutant Mass. But any workout nut holding a sports shaker bottle will give you a laundry list of the supplements he or she is ingesting daily, all purchased over the counter with ease.

If you take a walk around Winnipeg, the evidence is impossible to ignore. Gorilla Jack, Keebo Sports Supplements, Popeye’s and a host of other stores that sell countless variations of Creatine, BCAAs, l-carnitine, whey protein, testosterone boosters, nitric oxide and other supplements that are both unproven and unregulated when it comes to a clinical efficacy or safety. The products might well be safe, but the matter is open to question.

Each store’s website has its own set of fine print. Gorilla Jack’s says statements in its guide have not been evaluated by the FDA or Health Canada and use of the information “is at the sole risk of the reader.”

This is troublesome, said the U of M’s Myrie.

“Regarding health and performance claims on these products, Health Canada states that manufacturers are allowed to make claims providing they are supported by scientific evidence,” she said. “However, who is checking the validity of these claims relative to the science? What is the quality of the supporting evidence provided regarding specific claims, such as large randomized double-blinded, placebo-controlled scientific studies versus testimonials?”

I headed to the nearest workout supplement store in downtown Vancouver and asked for their top sellers, making sure each product had at least one ingredient listed on Health Canada’s workout supplement monograph.

Popeye’s, one of Canada’s most popular stores, calls itself a “sports nutrition retailer” and boasts 100 outlets. Popeye’s explicitly says on its website that it has not evaluated the products it sells and that Health Canada has not approved them to “diagnose, treat, cure or prevent disease.” It refers consumers to doctors for further information.

Popeye’s, which did not respond to multiple interview requests, has a top-ranked page in which consumers can handpick products with the highest star ratings. I picked five : All American EFX Kre-Alkalyn EFX, Fusion PURPLE•K, Dymatize BCAA Complex 5050, MuscleTech Platinum Creatine and Pharma Freak Test Freak.

• All American EFX Kre-Alkalyn had an NPN number. In total, three All American EFX, Inc. products have NPN numbers, though six are available online through Popeye’s.
• Fusion PURPLE•K has an NPN, and five such products are listed through Health Canada’s NPN database from the U.S.-based Fusion Nutrition Inc. Popeye’s website offers 13 different products.
• Dymatize BCAA Complex 5050 does have a NPN, and appears that the American company Dymatize Nutrition, which sells in Canada through Peak Performance Products Inc., has an NPN for all of its products.
• While Iovate Health Sciences International Inc., an American company that makes Muscletech products in Canada, has more than 200 products with an NPN, MuscleTech Platinum Creatine does not appear to have a number. There is Muscletech Platinum 100% Beef Protein, Muscletech Essential Series Platinum Gainer and Muscletech Essential Series Platinum 100% Whey, but no Platinum Creatine in Health Canada’s registered database.
• Pharma Freak Test Freak has an NPN through PharmaFreak Technologies Inc. in the U.S., which has 23 products licensed through Health Canada. Thirteen PharmaFreak products are available from Popeye’s. A few appear to have no NPN.

 

What this all boils down to is that picking a workout supplement with a Health Canada NPN is a bit like walking into an unlit store. You might get one that has met Health Canada’s apparently strict workout supplement guidelines, or you might get a product that has fallen through the cracks willingly, or simply by virtue of the fact that hundreds of thousands of workout supplement products are being sold in Canada and the U.S.

Eric Morissette, a senior media relations advisor at Health Canada, said, based on the information provided, the five products I had hand-picked “would appear to meet the definition of a natural health product.”

Health Canada was reviewing the information provided and would contact me if further action was needed, Morissette said. “Should it be determined that the products you have referenced are non-compliant, Health Canada will take appropriate action based on the risk posed to the general public. Please note that Health Canada is committed to following up on complaints regarding health products.”

It is easy to find products sold through websites like Popeye’s that make interesting claims, but have no NPN. But there could be more interesting findings in some products that have secured an NPN.

Take BrainPharma’s Happy Pills, part of Peak Performance Products Inc. and marketed, literally, to make you “happy”, — a weighty claim given the prevalence of mental health issues and depression in today’s culture.

While these “happy pills” in a “non-prescription feel good formula” have a NPN, they come with an extensive “cautions and warnings” note on Health Canada’s website that outlines requirements for consumers, though no doctor’s prescription is required.

These include avoiding excessive exposure to UV radiation and a warning to those suffering from scleroderma, which is the hardening and tightening of skin and connective tissues. Consumers are told to consult a doctor if they suffer sleep disturbances or use contraceptives, immunosuppressants, anticoagulant, anti-depressants, migraine therapies or anti-epilepsy drugs. Other conditions requiring a doctor’s opinion include high blood pressure, glaucoma, those taking lithium, anti-cancer medications, blood thinners, anti-HIV agents or cardiovascular medication.

The idea behind Health Canada is not only enforcement, but ensuring that products don’t slip through that shouldn’t, and that products don’t receive rubber stamps when they claim to do things like cure depression as Happy Pills suggest.

Morrissette said Health Canada’s enforcement system, the Canada Vigilance Program, is based on a consumer-reporting model. Consumers, he said, can report an adverse reaction to the program or to manufacturers.

“While reporting is voluntary for the general population, manufacturers are mandated to report back to Health Canada adverse reactions received for their products as required by Canada’s Food and Drug Regulations,” he said.

This could leave little incentive for a workout supplements manufacturer to comply with Natural Health Product Regulations when the overseeing body is largely an opt-in process, placing the onus on private businesses to meet standards only enforced if they apply for regulation.

“Does the NHP registration fall to the manufacturer?” asks U of M’s Semone Myrie. “That seems to be the message as per the information on Health Canada website.”

The page Myrie is referring to says natural health products must have a product licence and licences for their sites. Companies, it says, must provide “proper safety and efficacy evidence.”

Not all manufacturers and retailers participate in the wild west of workout supplements. Bridget Ridley, one of the managers of Winnipeg’s Muscles by Meyers, said the company prides itself on carrying and selling strictly products with Health Canada NPN numbers.

“Every single product that we sell has an NPN number,” she said. “Most reputable retailers should follow by that standard where they only sell products in Canada with NPN numbers. I have heard of some locations where different stores will sell stuff kind of under the table, kind of on the down-low.”

Ridley, however, agreed that Muscles by Meyers might be an anomaly among retailers.

“In Canada, it is much better than the States,” she said. “We like it because it gives us more substance to what we’re saying, we can show these people that there are NPNs and there is research behind the ingredients.”

 

“At the end of the day, nothing beats a healthy diet and regular exercise.”
— former supplements user Andrew Machuk

The unknowns and other dangers

Professor David Bishop is the Sport Research Leader at the Institute of Sport, Exercise and Active Living at Victoria University in Australia, where the workout supplements landscape is much like it is in Canada and the United States.

Supplements sold in a pill or powder form in Australia fall under the Therapeutic Goods Administration, not subject to heavy regulation. Sports foods, including bars and drinks, fall under the control of Food Standards Australia New Zealand. This body is tighter on claims allowed on product packaging, but once again, enforcement is low.

Bishop has published extensively in the area of human movement and sport science and in a recent paper monitored athletes’ performances while on supplements such as BCAAs, creatine and B-Alanine. Though the results were inconclusive at best, meaning supplements did little to improve athlete’s performance, Bishop noted the adverse effects of exceeding the recommended dosage.

“One is that for a lot of the supplements, we don’t have a lot of information on long-term health effects even when these supplements are taken in the recommended doses,” he added. “This problem becomes compounded when athletes start to take much higher doses than what is recommended, with the common thinking being that more is better.”

Bishop said too little is known about what happens when workout supplements such as creatine, BCAAs and l-carnitine are mixed together in one product, much like BSN recommends you do with its products.

“A second problem is that even though we have some information on the safety of individual supplements, there is virtually no information on what happens when you start to mix these supplements,” he said. “I would definitely recommend that anyone who’s considering using supplements consults a nutritionist or a dietitian and doesn’t simply buy them off the shelf.”

In March, the British Journal of Cancer published a study on links between supplement use and increased risk of testicular germ cell cancer in men. The study, observing men from Connecticut and Massachusetts, showed a “significantly elevated” risk of testicular germ cell cancer in men taking popular workout supplements with creatine, protein, and androstenedione. Right now, Health Canada has 132 NPNs that have creatine listed as an ingredient. While the study does not prove a link to muscle-building products, it exposes a glaring point about workout supplements in general, that evidence is starting to pour in, and it does not look good at all.

On June 1st, 2011, U.S. Army private Michael Lee Sparling, 22, took the recommended dose for Jack3d, a popular pre-workout supplement. He then headed out for a run in formation with his unit at Fort Bliss, Texas, collapsed, went into cardiac arrest and died later that day.

A year later, 30-year-old fitness fanatic and long-distance runner, Claire Squires, collapsed and died a few kilometres from the finish of the London Marathon. An inquest found she ingested the recommended dosage of Jack3d before the race.

Sparling and Squires are among the few known deaths now associated with DMAA (dimethylamylamine), which used to be in products like Jack3d and OxyElite Pro as well. Since the subsequent investigations and pressure from the families of Sparling and another soldier who died in similar fashion, the FDA put out a warning for DMAA. It received nearly 100 reports of adverse effects from people taking the supplement. Pressure was applied to companies which made products containing DMAA to remove them from shelves, but it appears the FDA cannot simply ban the substance or classify it as illegal as it is required by law to follow certain lengthy steps before it can ban supplements containing DMAA.

Health Canada described DMAA as a drug ingredient that has “not been approved for sale as an ingredient in drug products in Canada.”

I was able, nonetheless, to find a handful of American sites on the Internet still selling both Jack3d and OxyElite and the products could be shipped to Canada at additional cost.

Though there have only been a handful of incidents involving people who ingested, mostly in large quantities, workout supplements they thought were safe, natural ingredients and died shortly thereafter. But it was only after the deaths did government regulators and product manufacturers take action.

Machuk, now off supplements with no plans to resume, has choice words for those caught up in the current craze. Supplements, he said, often come with claims of improved performance, but without clinically proven studies relative to their use.

“Often these supplements, when taken in low doses, do not cause side effects, however the potential for harm is still apparent,” he said. “At the end of the day, nothing beats a healthy diet and regular exercise.”

One is left to wonder what’s in store for the rest of us without medical degrees chugging and mixing shakes with God only knows what in it. And in the wild west of workout supplements, how many other potentially deadly ingredients are slipping through the cracks? Given the landscape of government oversight and the product manufacturing sector, it might be wise to think twice the next time you’re inundated with outrageous health claims, fine print and multiple asterisks.

 

Patrick Blennerhassett is a freelance writer/editor based in Vancouver. He is a Jack Webster Fellowship Award winner and has published two novels.

Land of confusion

Health Canada has the Natural and Non-prescription Health Products Directorate. Its website cites a 2010 Ipsos-Reid survey that shows 73 per cent of Canadians regularly take natural health products such as vitamins and minerals, herbal products, and homeopathic medicines. Workout supplements, however, are relatively new products, straddling regulatory lines and hopping international borders with ease.

Under Health Canada’s Natural Products Regulations, in effect since 2004, workout supplements fall under a monograph page that groups ingredients into six categories: proteins, amino acids, carbohydrates, ergogenic agents, vitamins and minerals and complementary ingredients. Anything containing one of these listed products, and there are well over 100 of them, could also fall under the Canadian Food Inspection Agency (CFIA) if it is a sports supplements, such as a sport drink, protein powder, energy bar, or meal replacement product or beverage. Confusion may arise over who has regulatory oversight.

Example 1:

Take BioSteel’s High Performance Sports Drink, a licensed Natural Health Product, because it contain ingredients such as L-Glutamine and various forms of amino acids. But if BioSteel were to fall under the CFIA, and be classified as a Sports Nutrition Product, as it contains many of the agency’s requirements, it also appears it would be in violation of two clauses set down on the CFIA’s website, in which you cannot makes claims surrounding the diagnosis, treatment, mitigation or prevention of a disease in human beings or animals.

BioSteel’s website makes multiple claims along those lines, including “providing sustained energy, mental clarity and quicker recovery when you need it most.” Available at more than 1,300 locations across Canada, the product, according to its website, will “support and increase the rate of metabolism; Maintain healthy skin and muscle tone; Enhance immune and nervous system function.”

Example 2:

CytoSport’s CytoGainer, an American-made powder that contains 56 grams of protein, established at 108 per cent of daily intake for that nutrient, and 80 grams of carbohydrates, equalling 27 per cent of the recommended daily intake, could easily be classified as a “meal replacement” and fall under CFIA’s jurisdiction. It also contains ingredients on Health Canada’s workout supplement monograph, including 1.5 grams of creatine per two scoops, all three BCAAs, and amino acids.

CytoSport said its products are “in compliance” with the Certified for Sport program of NSF International, also known as the Public Health and Safety Organization, a U.S.-based body which “establishes international standards for third-party certification.” There is, however, no reference to any partnership with the FDA, Health Canada, or any other standardization body. The products have no Health Canada NPN.

The Natural Health Product registry is supposed to be the answer to regulating workout supplements. Yet it appears that when it comes to regulatory oversight, it’s buyer beware.