Is Pediatrics Creatine Study Sloppy Research on a Safe Supplement?

Creatine supplements are once again under scrutiny, as a new study published online Jan. 2 in the journal Pediatrics blasted supplement retailers for recommending creatine to teenage athletes and called for more intense regulation of the sale of the sports supplement to minors. However, the supplement industry responded by reiterating that creatine is one of the most well-researched supplements and has relatively few safety concerns when taken as directed.

“Creatine has a wonderful safety profile," said Dan Fabricant, Ph.D., executive director and CEO of the Natural Products Association (NPA), which represents most supplement retailers, including both independent and mainstream channels.

The Pediatrics article and its wide coverage in mainstream media (e.g CNN and NPR) is a shot across the bow for the creatine and sports nutrition industry.

The study was published by researchers from the Division of Developmental and Behavioral Pediatrics, Steven and Alexandra Cohen Children’s Medical Center of New York; and North Shore-Long Island Jewish Health System, Lake Success, New York.

Posing as 15-year-olds, adult research staff called 244 health food stores across the United States in August 2014 and asked for dietary supplement recommendations for increasing muscle strength. New Jersey retailers were excluded due to pending state legislation that aims to make the sale of creatine to minors illegal, but the study preceded a similar legislative effort in Massachusetts, so retailers there were included. Regardless, both bills failed to pass.

Around 67 percent of stores contacted recommended creatine without prompting. If a store initially did not recommend creatine or testosterone boosters, the caller asked specifically about those supplements. Nearly 28 percent of stores recommended creatine after being prompted, while nearly 10 percent recommended testosterone-boosting supplements.

The callers also asked if it was OK for a 15-year-old to purchase these supplements, and 74 percent said it was fine for them to purchase creatine; just over 41 percent said a testosterone-booster purchase was allowed.

The main takeaway for the study authors was that advice from health food stores contradicted common label statements that these supplements are not recommended for use by those under the age of 18.

“Given that many health food stores claim that their sales attendants are experts in health and wellness products and emphasize the ability of their staff to provide consumer education, it is likely these recommendations will be accepted," the authors wrote. “Thus, recommendations from sales staff that run counter to product labeling and expert medical opinion pose potentially significant health risks to young teenagers who use creatine and/or testosterone boosters."

However, Fabricant noted while some retail staff may need more training on handling such calls, the study failed to detail the full conversations with retailers, including any common dietary supplement advice given by the retailers—and the industry as a whole—such as advice to use supplements as directed and share supplement use information with one’s physician.

“This is just sloppy research," he said, saying the study lacked specificity. “What kind of creatine [was recommended]? Monohydrate? Hydrochloride?"

Staff Training or Regulation Changes?

The study authors urged these “profit conscious" health food stores to consider revising its staff policies for recommending products like creatine and testosterone-boosting supplements to minors. “Simple solutions could include improving the knowledge of their staff about supplements not recommended for youth, enabling their point-of-sale software to caution about use of these products by minors, and conducting audits to verify compliance with these policies," they said.

If the study publication had solely called out health food stores for being lax with its staff training on sales of certain supplements to minors, many in the industry would agree such retailers have a great responsibility and more training could be beneficial. 

“Retailers can be an important resource for consumers when it comes to making health decisions, and so we urge retailers to be part of the efforts to educate consumers on smart dietary supplement use, including encouraging consumers to open a dialogue with an on-staff pharmacist or registered dietitian, or their own doctor or other healthcare practitioners," said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), in a statement.

However, the study also questioned the regulation of dietary supplements. The authors called for creatine sales to be limited to those over the age of 18, noting the sale of cigarettes, alcohol and spray paint to minors is prohibited by state and federal laws. Such laws are needed, they said, because FDA’s regulation of dietary supplements is insufficient.

 “Under its current mandate, the FDA’s role with respect to dietary supplements is reactive, not proactive, thereby allowing for unprecedented growth in the development and marketing of these untested products," the authors wrote.

Fabricant, a former director of the dietary supplements program at FDA, pointed out nine new dietary ingredient notifications (NDINs) for creatine have been submitted to FDA over the years, giving FDA at least that many chances to take issue with the safety of the ingredient. “FDA has been silent," he said, “because there is no [safety] issue."

At press time, FDA had not yet responded to INSIDER’s request for a statement on whether the agency has had any concerns about the use of creatine, especially by minors. However, FDA informed INSIDER that clinical reviewers at FDA’s Center for Food Safety and Applied Nutrition (CFSAN) monitor dietary supplement adverse event reports (AERs) to identify safety concerns—dietary supplement companies are required by law to submit serious AERs to FDA. Potential safety concerns identified from a CFSAN review of AERs are investigated before any action is taken.

“The product may not have been the cause of the adverse event, or the results of the investigation may be inconclusive," FDA noted. “In many cases, the person experiencing the event has used more than one FDA-regulated product (such as a dietary supplement and a prescribed drug) or has a pre-existing condition."

Mister reiterated there is no known safety issue that would prevent healthy people from using creatine. “Out of an overabundance of caution, some companies that manufacture creatine have noted on the product labels that it is not recommended for people under the age of 18," he said, noting this recommendation is to encourage responsible use by its consumers; this does not suggest any safety concerns.

Fabricant said retailers should be allowed to recommend scientifically studied supplements, and creatine is a one of the few supplements that actually has been studied in people under the age of 18. “Conducting such studies in this age population is not an easy task," he reminded.

Creatine Research: Fact vs. Perception

Creatine is found naturally in foods such as meat and fish. Most creatine in the body is stored in the muscles as creatine phosphate and is used to quickly restore energy—helping to restore the “energy molecule" adenosine triphosphate (ATP). Athletes supplement with creatine to increase muscle levels and generate a bit more energy to go longer during rigorous but short bursts of exercise, such as in weightlifting or sprinting.

The American Academy of Pediatrics (AAP), publisher of Pediatrics, has taken the position creatine supplementation is not recommended for minors, citing safety concerns and a lack of studies in pediatric populations.

The supplement industry has countered creatine is well-studied and safe, even in pediatric age groups.

Anthony Almada, founder and CEO of Vitargo Global Sciences, said numerous studies have been conducted on creatine use in adolescents and even infants. He was formerly co-founder of EAS, which was the first company to bring creatine monohydrate supplements to market in 1993.

In conjunction with University of Memphis exercise and sports nutrition scientist Richard Kreider, Ph.D., who is now with Texas A&M University, a team of researchers found no adverse side effects (e.g., gastrointestinal distress, medical problems or negative symptoms) in adolescent athletes taking EAS Phosphagen™ creatine monohydrate supplement (Int J Sport Nutr. 1997 Dec;7(4):330-46).

In 2007, the International Society for Sports Nutrition (ISSN) published a position stand in the Journal of ISSN (JISSN) that, in part, addressed misconceptions about the use of creatine in teens.

In this paper, Kreider and other ISSN fellows stated no study has shown creatine monohydrate to have adverse effects in children. “In fact, long-term creatine monohydrate supplementation (4 to 8 g/d for up to three years) has been used as an adjunctive therapy for a number of creatine synthesis deficiencies and neuromuscular disorders in children," they noted.

Almada said starting in 1994, researchers studying infants with creatine deficiencies found creatine supplementation in this population was safe up to double the typical adult dose (200 mg/kg bodyweight, for first five to seven days only). “Every single day, these infants are getting 400 to 800 mg/kg bodyweight, for life," he said, referring to research (Semin Neurol. 2014 Jul;34(3):350-6) by Sylvia Stockler-Ipsiroglu, M.D., Ph.D., Department of Pediatrics, University of British Columbia, Canada, a pioneer of creatine pediatric study. “These are not 15-year-olds, but 15-month-olds."

Almada said the only side effect ever reported in such research was the appearance of creatine crystal in urine, but no kidney damage.

Further, Almada pointed out several studies investigating creatine in various adolescent populations were funded by the National Institutes of Health (NIH), including the work of Perry Renshaw, M.D., Ph.D., University of Utah.

Renshaw and his colleague, University of Utah child psychiatrist and brain researcher Doug Kondo, have focused on high-dose creatine supplementation in adolescent females.  “I am not aware of significant [adverse effects] that have come up in the course of these studies," he told INSIDER.

Almada said such studies on creatine supplementation in adolescents are suspiciously missing from the Pediatrics article. “If NIH and the University of Utah had concerns about creatine ingestion, do you think they would’ve approved these studies?," he reasoned. “Absolutely not."

Among the studies cited in the Pediatrics article as evidence of potential adverse effects of creatine use on liver and kidney health, as well as possible dehydration and cramping, included research on rats (J Sports Sci Med. 2009 Dec 1;8(4):672-81) that found one to two months of creatine supplementation may affect kidney and renal function in sedentary but not exercised rats. However, on the subject of hydration and cramping, the paper cited a systematic review that found no such side effects from creatine use in athletes (J Athl Train. 2009 Mar-Apr; 44(2):215-223). “No substantial evidence currently exists showing that creatine supplementation hinders the body's ability to dissipate heat or body fluid balance when appropriate doses are consumed," the reviewers wrote.

“We have published studies for up to three years in athletes competing in Division One baseball and football," Almada said, noting the studies looked at indices of safety and were conducted in the hot and humid environment of Memphis. “There was no greater incidence of adverse events in those taking creatine compared to those taking a carbohydrate placebo."

Déjà Vu?

The debate on creatine’s use by teenage athletes is not new. It isn’t even a new topic for Pediatrics. Back in 2001, the journal published results of a survey of 1,103 young athletes between the ages of 10 and 18 (108, 2:421-5). The survey found creatine use at every age level, from grade 6 and up. Just under 75 percent of the young athletes said they took creatine for performance enhancement. The authors concluded, until the safety of creatine can be established, its use in minors should be discouraged.

Mister stated dietary supplements, including creatine, can play a valuable role in supporting healthy lifestyles for people of all ages, and it is especially important for younger populations—such as adolescents and teenagers—to discuss their dietary supplement use with their parents, coaches, doctors or other healthcare practitioners. “As with any supplement, creatine is intended to supplement a healthy diet in combination with other healthy habits," he said. “Creatine—or any sport supplement—is not a shortcut or a substitute for the hard work and training that is required to excel in athletics."

The question is, how can minors purchase and use creatine safely?

In its position stand, ISSN listed several recommendations:

“If these conditions are met, then it would seem reasonable that high school athletes should be able to take a creatine supplement," the ISSN stated. “Doing so may actually provide a safe nutritional alternative to illegal anabolic steroids or other potentially harmful drugs."

Almada, Mister and other supplement industry experts said prohibiting the sale of creatine to minors may not solve any of the concerns expressed in the Pediatrics article.

“Extreme measures, such as putting something behind a counter, will only make a product more enticing for that specific population looking to be protected—and unnecessarily limit access and availability for all consumers," Mister said, in a statement.

Almada honed in on the article’s mention of cigarettes and alcohol. “Adolescents still get cigarettes and alcohol," he said. “They will find another way. A ban on the sale of creatine will not stop its use." Instead, he reasoned if safety is a concern, it is important to first demonstrate the actual risk, not a judgment with bias, but by hard scientific evidence. He suggested the creatine industry, including manufacturers and suppliers, could collectively invest in research on creatine supplementation in both male and female adolescents over a period of eight months or more, and compare any adverse effects to carbohydrate placebo. He added such an effort could include input from AAP and other creatine critics.

Until then, he recommended teens seek advice from true experts in sports nutrition and creatine, which often excludes most doctors and even retailers. “In my 25 years of working in academic research, I’ve come across maybe two physicians who were even semi-conversant on creatine, let alone any other dietary supplement and athletes," he lamented. “Physicians don’t know jack." He added dietitians also don’t tend to have expertise on supplements and sports. “Many healthcare experts dismiss the safety and efficacy of creatine because they are ignorant and have no interest in it."