If there’s one thing that unites all countries and cultures, it’s our love of caffeine. Whether it’s coffee, tea or other foods, caffeine is the most widely consumed drug in the world — more than alcohol, and more than tobacco: 90% of adults worldwide consume caffeine daily. At doses found in food and beverages, the effects are predictable and the side effects are slight. But natural or not, caffeine is a drug; isolate the pure substance, and the risks change. It would be difficult for most people to drink 16 cups of coffee in a row, but that’s the equivalent of just one teaspoon of caffeine powder. If that doesn’t hospitalize you, a tablespoon of the powder will probably kill you. Yet despite the risks, there are no restrictions on the sale of caffeine powder. You can buy a 1kg bag for $35, which provides the caffeine of about 5,000 cups of coffee. Caffeine powder is freely available to buy because regulators treat it differently – not because of its inherent properties, but because it’s “natural” and sold as a dietary supplement rather than a drug. This is a regulatory double-standard that harms consumers. It’s leaving a body count. And it needs to change:
A year ago, Logan Stiner of LaGrange, Ohio, was an honors student and prom king looking forward to his high school graduation. “He was burning the candle at both ends, because he had a couple of projects that he had to finish for finals,” said his mother, Kate Stiner. On May 27, his brother found him unresponsive on their living room floor. In an effort to increase his energy, Mr. Stiner had used caffeine powder a friend had purchased on Amazon, but miscalculated the dosage, overdosed and died. The medical examiner said the cause of death was “cardiac arrhythmia and seizure, due to acute caffeine toxicity due to excessive caffeine ingestion.”
A few weeks later, 24-year-old James Wade Sweatt, a newly married, recent college graduate living in Georgia, blended a drink with powdered caffeine, also purchased online. Health conscious, he reasoned that pure caffeine and water would be a healthier way to get a lift than the Diet Mountain Dew that he usually drank. He overdosed, fell into a coma and died.
Caffeine is a natural substance produced by over 60 plants. Chemically, caffeine is 1,3,7-trimethylxanthine. Why so many plants produce this chemical is not well understood, as it’s not essential for a plant’s survival. Whether caffeine is a pesticide (repelling invaders) or a herbicide (fallen leaves inhibiting plant growth) isn’t clear. When consumed, caffeine is a central nervous system stimulant, increasing your heart rate and respiration. It also relaxes smooth muscle (producing another known effect) and is a mild diuretic. When used at modest (food-like) doses, caffeine is considered safe to consume. At usual daily doses of 100-200mg per day, caffeine reduces feelings of fatigue and raises perceptions of alertness. As a drug, caffeine has some medicinal uses. Caffeine is chemically very similar to theophylline, an old drug used to treat asthma and other lung diseases. It is combined with some painkillers for headaches and migraine. There’s some evidence it can improve athletic performance. Then there’s a long list of unproven but promising attributes, such as reducing the risk of type 2 diabetes or Parkinson’s disease. I’ve written before about how it is used for conditions like ADHD without good evidence it actually works.
Given its frequency of use, caffeine overdoses are rare, because the amount in foods and drinks are modest enough to make overdose difficult. Abuse can occur, and at high doses (the equivalent of 80+ cups of coffee), caffeine can be fatal. When abused, caffeine can produce feeling of euphoria. In an overdose situation, caffeine causes delusions, hallucinations, and heart conduction abnormalities, leading to death.
Despite its roots as a natural product, powdered caffeine is similar to the caffeine in soda in that it is synthetic, and not actually derived from natural sources at all. Apparently Americans are importing 17 million pounds of it, with much of it going to soda. Recently it has started to appear in other products, like gum, marshmallows, gummi bears and even sunflower seeds.
A lack of meaningful regulation
Caffeine that’s packaged as a dietary supplement is sold virtually unregulated in the United States, not because of a loophole in regulations but because of the explicit intent to remove regulatory barriers and limit any action from the FDA. The Dietary Supplement Health and Education Act of 1994 (DSHEA) is an amendment to the U.S. Federal Food, Drug and Cosmetic Act that establishes a regulatory framework for dietary supplements. It effectively excludes manufacturers of these products from virtually all regulations that are in place for prescription and over-the-counter drugs. The FDA notes:
Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading. FDA’s post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.
The FDA recognizes the problem with powdered caffeine, but in its warning to consumers, it is clear that the agency is powerless to do anything meaningful about it:
The FDA is warning about powdered pure caffeine being marketed directly to consumers, and recommends avoiding these products. In particular, FDA is concerned about powdered pure caffeine sold in bulk bags over the internet. The FDA is aware of at least two deaths of young men who used these products. These products are essentially 100 percent caffeine. A single teaspoon of pure caffeine is roughly equivalent to the amount in 25 cups of coffee. Pure caffeine is a powerful stimulant and very small amounts may cause accidental overdose. Parents should be aware that these products may be attractive to young people.
No recalls, or “stop sales” orders. Just a warning to consumers. The FDA notes that manufacturers can add caffeine to foods as long as they include it on the ingredient list. When it approved adding caffeine to cola back in the 1950s it could not have contemplated how many foods and products like energy drinks would be supplemented with caffeine today. The only recent action was in 2010 to prohibit caffeinated alcoholic beverages – for obvious reasons.
While some supplement industry groups are supportive of restrictions on the sale of bulk powder, others disagree. The Natural Products Association does not support regulation. After all, salt and water can kill you, just like caffeine:
Take water [or] salt for example — if you use too much, it creates problems. I think that’s really the issue here. People safely use caffeine every day.
But this argument ignores fundamental facts. It’s true that the dose makes the poison, but the recommended dose of caffeine is tiny. You can’t accurately measure or weigh 200mg of caffeine powder using home measures and scales. And no-one is likely to seek an energy boost from consuming sodium or water.
Short of any federal regulation (the FDA remains noncommittal beyond a warning), other legislation is pending. Some senators have asked the FDA to act. While caffeine sales bans have been proposed at the state level, it’s not likely to have any meaningful effect when you can buy this product over the internet. There’s also the litigation approach:
Amazon.com and caffeine powder distributors didn’t provide proper warnings about the supplement’s dangers, resulting in the death of an Ohio high school student last year, the teen’s father said in a lawsuit filed Friday.
Eighteen-year-old Logan Stiner was just days from graduating high school in northeast Ohio when, on May 27, his brother found him unresponsive in the family’s home in LaGrange, southwest of Cleveland. A coroner ruled that Stiner died of cardiac arrhythmia and seizure due to acute caffeine toxicity. The amount of caffeine in his system was about 23 times greater than the level in a typical soda or coffee drinker. Stiner was a popular student who was voted prom king, wrestled and planned to study chemical engineering at the University of Toledo.
The lawsuit names as defendants a classmate who gave Stiner the caffeine powder; Amazon, which shipped it to the woman last March; and six Arizona-based companies that the father’s attorney said packaged and sold the pharmaceutical-grade powder under the name Hard Rhino. The lawyer, Brian Balser, said Friday that the Arizona companies appear to be related.
As long as we maintain a regulatory double-standard for supplements and “natural” products, there is not likely to be much change, and we can probably expect more people to die from caffeine powder overdoses.
“It’s natural, therefore it’s safe” is an appealing yet baseless health myth. Yet this is the primary argument that has been used to give supplements and natural health products completely different regulatory structures than what exist for drug products. Weaker regulation of supplements and natural health products has been a boon to manufacturers, but the same can’t be said for consumer safety. Natural or not, we need to assess the risk and benefits of products on their own merits, not simply because some chemicals happen to be produced by plants. We need meaningful regulation that acknowledges this.