Tag: caffeine powder

06/1/18

Pure Caffeine Crackdown

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On April 13, 2018 the FDA announced new restrictions on the sale of so-called dietary supplements containing high amount of caffeine. The new guidelines restrict the sale of pure or highly concentrated caffeine products in powder or liquid form directly to consumers in bulk quantities. They were said to pose a significant public health threat because of the high risk they will be used in excessive, potentially dangerous doses. A single teaspoon of powdered caffeine contains approximately 3,200 mg of caffeine—the equivalent to about 20 to 28 cups of coffee—a potentially fatal dose of caffeine. The FDA said it was prepared to take immediate steps to begin removing illegal products from the market.

The recommended serving of highly concentrated or pure caffeine products is 200 mg, equal to 1/16 of a teaspoon of pure powder, or 2.5 teaspoons of liquid. The FDA press release said the risk of overuse and misuse is high when these products are sold in bulk quantities, given the expectation of the buyer making small, precise measurements per recommended serving. Despite the small serving sizes, “powdered forms of caffeine are sold in large bags and liquid forms are sold online in bottles that can contain a gallon or more.” Often consumers don’t have the right tools to correctly measure the small dosage amounts so they are at risk of ingesting too much concentrated or pure caffeine.

Another concern is these products can resemble safe, household items like water, distilled vinegar, flour or powdered sugar. “The consequences of a consumer mistakenly confusing one of these products could be toxic or even lethal.” The new guidance does not apply to products such as prescription or over-the-counter drugs containing caffeine or conventional caffeinated beverages. The FDA commissioner, Scott Gottlieb, was quoted as saying:

 Despite multiple actions against these products in the past, we’ve seen a continued trend of products containing highly concentrated or pure caffeine being marketed directly to consumers as dietary supplements and sold in bulk quantities, with up to thousands of recommended servings per container. We know these products are sometimes being used in potentially dangerous ways. For example, teenagers, for a perceived energy kick, sometimes mix dangerously high amounts of super-concentrated caffeine into workout cocktails. The amounts used can too easily become deceptively high because of the super-concentrated forms and bulk packaging in which the caffeine is being sold. . . . We’re making clear for industry that these highly concentrated forms of caffeine that are being sold in bulk packages are generally illegal under current law. We’ll act to remove these dangerous bulk products from the market.

Concern with the public health risk of products containing concentrated, high levels of caffeine is not new. In September of 2015 the FDA issued a warning that “Pure and highly concentrated caffeine products present a significant public health threat and have contributed to at least two deaths in the United States.” The FDA then issued warning letters to five distributors of pure powdered caffeine. In March of 2016 the FDA sent two additional warning letters to manufacturers. See the 2015 FDA announcement for links to the warning letters.

The FDA warnings about dietary supplements with high concentrations of caffeine reported knowledge of at least two confirmed deaths attributed to these products. This was apparently referring to a 2014 FDA article, “Tragic Deaths Highlight the Dangers of Powdered Pure Caffeine.”  The article described the unfortunate deaths of two men, an eighteen-year-old high school senior and a 24-year-old college graduate who died after using pure powdered caffeine products. These aren’t the only two deaths linked to these products. The Washington Post highlighted the case of a South Carolina teen who died in April of 2017 of a “caffeine-induced cardiac event” after drinking a latte and a Mountain Dew, then chugging an energy drink within the span of two hours.

In 2015 a group of US senators sent a letter to the FDA requesting the agency require clearer labeling on powdered caffeine products and a ban on the retail sale and marketing of such products to consumers. They renewed their call to the FDA to take action on the 2015 requested ban on April 26, 2016 as the FDA still had not taken any action. In the 2016 letter, the senators said:

It is disturbing that despite two unintended and untimely deaths associated with powdered caffeine, the FDA has done little to regulate these products or adequately enforce the standards in place to protect Americans from the substantial risk associated with ingesting powdered caffeine in any form. . . . Unfortunately, in the absence of strong regulatory action, companies are continuing to develop new delivery mechanisms and creative advertising ploys to attract new powdered caffeine users and are doing so without relaying the serious health consequences of improper use.

The senators also sent information to the FDA on data from the nonprofit organization, the Center for Science in the Public Interest (CSPI), supporting the requested ban on the retail distribution of pure and highly concentrated caffeine products. In their April 26, 2016 letter to the FDA, CPSI noted while the five dietary supplement companies who received warning letters by the FDA in 2015 voluntarily removed pure caffeine products from their retail sales, “pure caffeine in powdered (PPC), liquid (PLC) and now inhalable (IC) forms is still widely available for purchase online.” A basic internet search found at least fifteen online suppliers. Five of these were domestic suppliers and ten were international suppliers based in Canada, the United Kingdom, India and China.

This compelling evidence demonstrates why a ban is the only step that will protect consumers from the hazards of PPC. Moreover, a ban would prevent legal importation of this dangerous substance into the country from foreign suppliers.Given the evidence, and vocal support from experts, parents, and trade associations, CSPI reiterates the need for a complete ban on the retail distribution of highly concentrated caffeine marketed as a dietary supplement. This includes specifying limits on the form in which caffeine is sold, including its labeling, serving sizes, and potency, to minimize the risk of accidental overdose by all potential users, including young consumers.

Senators Sherrod Brown (D-OH), Richard Blumenthal (D-CT), and Dick Durbin (D-IL) voiced their support to the FDA ban they have been seeking for the past four years. Senator Brown said: The FDA’s decision to ban the direct sale of pure, lethal powdered caffeine will finally bring about the consumer protections we have been demanding for years.” Senator Blumenthal said: “The FDA has rightly heeded our call to take swift action to get highly concentrated bulk caffeine products off the market. Pure caffeine is simply unsafe and has long posed dangerous – even deadly – risks to unsuspecting consumers. Robust enforcement action will go a long way towards stopping senseless and tragic caffeine overdoses.” Senator Durbin concurred with these sentiments, saying he was glad to see the FDA heeded their call to action, adding that when sold in bulk, “it is nearly impossible for consumers to tell the difference between a safe dose of pure powdered caffeine and a lethal one.”

For more information on problems with energy drinks and other products with high caffeine concentrations, see:  “Overdosing On Energy Drinks” and “Killer Caffeine.”

03/30/15

Killer Caffeine

© : Santi Sinsawad | 123RF.com
© : Santi Sinsawad | 123RF.com

I knew of a woman who had a dual addiction to marijuana and caffeine. Yes, caffeine. She drank several pots of coffee throughout the day along with smoking marijuana. While a resident in a long-term rehab for women, she repeatedly denied that she had caffeinated coffee. But the staff “knew” she was somehow getting it and using it because of the coffee stains on the rug in her room. Several room searches were done to no avail. Finally she was busted. What the woman had done was smuggle a Melita filter and caffeinated coffee into the facility when she out for an appointment. In all the years I’ve worked with substance use/abuse disorders, this was the only time I’d ever seen such classic addictive behaviors with caffeine.

The last several years have seen the marketing of energy drinks with high caffeine content, and the use of products like 5-hour ENERGY “shots.” Many of the individuals I meet in early recovery are drawn to energy drinks, so I’ve been watching for news and research on them. I’ve heard of some concerns about their safety. And recently I heard about powdered caffeine. Just one teaspoon contains 3,200 mg of caffeine.

So let’s start with some basic information about caffeine before we get to the reported deaths from using caffeine powder. According to Wikipedia, caffeine is the world’s most widely consumed psychoactive drug. It is legal and unregulated in most countries worldwide. In North America, 90% of adults consume caffeine daily. I am one of them. A seven-ounce cup of coffee contains 80 to 175 mg of caffeine, depending upon how it is prepared (drip, percolation or espresso). Toxic doses of caffeine for an adult are over 10 grams—twenty times higher than the average consumption of 500 mg per day.

Caffeine’s positive effects have to do with reducing fatigue and preventing drowsiness. It can even stimulate faster and clearer thought flow, increased focus and better general body coordination. Consistent with this last effect, moderate doses of caffeine can improve athletic performance, but the improvements are not usually substantial. There can be some undesired effects, such as mild anxiety, insomnia, and jitteriness. Although there are caffeine-induced disorders in the DSM-5, caffeine use is usually not considered to be addictive.

Caffeinism can occur when 400 to 500 mg at one time, or 1,000 to 1,500 mg per day or more of caffeine is consumed. Winston et al. noted that the symptoms that occur (restlessness, agitation, excitement, rambling thought and speech, and insomnia) overlap with those of several psychiatric disorders. Extreme overdose can result in death. The estimated lethal dose in humans is estimated to be equivalent to 150 to 200 milligrams per kilogram of body mass; the caffeine in roughly 80 to 100 cups of coffee for an average adult. You can read further about caffeine in a 1981 article, “Caffeine: Psychological Effects, Use and Abuse.” As always with psychoactive substances, you can also see what Erowid has to say about caffeine.

Now, let’s look at caffeine powder. In May of 2014, 18-year-old Logan Stiner died after ingesting 23 times the amount of caffeine found in a typical cup of coffee. Given the above noted information, Logan would have consumed 1,850 to 4,025 mg of caffeine.  While the estimated lethal dose given above would seem to be higher than Logan’s intake of caffeine powder, he still clearly consumed roughly four to eight times the dose needed for caffeinism. Several reports have indicated that a teaspoon of caffeine powder, the equivalent of 25 cups of coffee, can be lethal. Logan’s use of caffeine powder did approach that level. Caffeine powder is a pure chemical. And as Mary Clare Jalonick reported:  “the difference between a safe amount and a lethal dose is very small.”

The FDA has warned against the use of powered pure caffeine. They are particularly concerned about Internet sales of bulk bags of it. “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.” Michael Landa, the Director of FDA’s Center for Food Safety and Applied Nutrition, reported having a December 2014 meeting with Logan’s parents and the parents of a 24-year-old who died after ingesting powdered caffeine. He said:

I cannot say strongly enough how important it is to avoid using powdered pure caffeine. The people most drawn to it are our children, teenagers, and young adults, especially students who want to work longer to study, athletes who want to improve their performance, and others who want to lose weight.

The FDA doesn’t have the legal authority to just pull these products off the shelf. Caffeine powder is sold as an unregulated dietary supplement—unlike caffeine added to soda and other drink products. This is a common way of getting around regulation with several other potentially harmful psychoactive substances (see Krypton Can Kill You; Kava is not a Magic Bullet).

Michael Taylor, the FDA’s deputy commissioner of foods, said it was inherently irresponsible to market such a potentially dangerous product. “I would hope that people would get the message that they just ought to stop selling it.” So far, they don’t seem to be getting that message.

David Templeton, of the Pittsburgh Post-Gazette, reported that six senators have sent a letter to the FDA urging them to ban the retail sale of caffeine powder. The letter stated that pure caffeine is unsafe. Overdosing is easy and virtually unavoidable. Powered caffeine sold in bulk was said to be markedly different than other caffeine products, on the market, such as energy drinks, energy shots and others. “Because of the risk powdered caffeine poses to consumers, these products merit swift and significant action by the FDA.” The Council of Responsible Nutrition, a trade association for the supplement industry, recently stated their support for an FDA ban against the retail sale of caffeine powder. NutraKey, a major online marketer of caffeine powder did not respond to requests for comment.