Recently FDA issued warning letters to several marketers of pure powdered caffeine declaring that the bulk sale of this substance to consumers violates the Food, Drug & Cosmetic Act because, when sold in bulk, pure powdered caffeine presents a serious risk of illness or injury despite the suggested serving level on the labeling. At issue is whether consumers can appropriately dose themselves when the ingredient is sold in its purified form in large quantities.
Pure powdered caffeine is a white powder that is essentially 100 percent synthetic caffeine without any of the binders and fillers that might be added to finished products to “cut” its potency. In that form, anywhere from 1/32 to 1/14 of a teaspoon can provide about 200 milligrams of caffeine—the same amount as one would expect to find in two cups of coffee. It is being sold in bulk bags of anywhere from 25 grams (about 125 servings) to 25 kilograms (about 125,000 servings!).
The problem is not the ingredient as much as it is the concentration of pure powdered caffeine and the fact that so little carries so much of a punch. Even if the bulk bags provide directions that 1/16 of a teaspoon equals a serving, can average consumers use the product according to those directions? And will they? Can a consumer population accustomed to measuring sports nutrition products with 1/8 cup scoops appreciate the risks of exceeding 1/16 teaspoon? Even if consumers have a 1/16 measuring device (often called a “pinch” measuring spoon) or a milligram scale in their kitchen, it’s too easy to make a mistake. Add a little too much salt or pepper to your pot roast and you change the taste; but add a little too much of pure powdered caffeine in your post-workout smoothie and you might never be able to taste—or do anything else—again.
FDA has already documented two cases in which young, otherwise healthy men overdosed themselves (apparently unintentionally) with pure powdered caffeine and died.
Which brings us back to the industry’s moment of decision: Will supplement manufacturers and marketers support FDA’s action and join the call to remove pure powdered caffeine from the consumer marketplace, or will they dig in and defend a few companies’ ability to sell a potentially dangerous product under the banner of DSHEA?
We decided to support FDA’s call for the removal of this product
At CRN, that decision was easy. We decided to support FDA’s call for the removal of this product from the consumer marketplace. Do consumers really need to buy five kilogram bags? The safety risks of mismeasuring or overdosing outweigh the benefits. Moreover, hunkering down to protect a hypothetical “right” to sell a dietary ingredient in bulk would put the industry on the wrong side of consumer safety and cultivate the impression that we are defending the right of a few marketers to peddle a dangerous substance.
So CRN amended its existing Recommended Guidelines Caffeine-Containing Dietary Supplements to include a recommendation against selling pure powdered caffeine in bulk to consumers (legitimate business-to-business transactions are permitted). Further, CRN has supported FDA’s action by calling for non-CRN members to stop selling this product as well as urging FDA to act swiftly, using the full extent of the enforcement tools the law provides to remove it from the market.
FDA has already persuaded industry action with regard to over-the-counter (OTC) pediatric cough/cold medicines. Despite dosage instructions on packaging, the agency raised legitimate concerns that many consumers couldn’t determine the appropriate dose for children of various ages and weights and that the measuring devices provided with many of those products only contributed to the confusion. So OTC manufacturers collaborated with FDA to develop clearer instructions, new measuring devices that accompany the products, and consumer education to teach parents how to appropriately medicate their children. That’s what a responsible industry does. Similarly, marketers of pure powdered caffeine could develop packaging for their purified caffeine in single serve dosages if they want to sell it directly to consumers. That would certainly make the “conditions of use” described in their labeling more feasible and realistic.
Some have suggested that to acquiesce to FDA and to remove, or even repackage, these products would lead to the metaphoric slippery slope, and before we know it, FDA would be alleging vitamin C isn’t safe. Sometimes the “slippery slope” is no slope at all, and a clear demarcation exists. Is pure powdered caffeine an ingredient for which we want to fall on our proverbial swords? Does the industry think that any dietary ingredient potent enough that a teaspoon of it could kill someone should be available to consumers in bulk form—whether it’s ephedrine or caffeine or the purified form of an herbal extract? Consumers don’t need access to purified ingredients that are sold in a manner that turns a blind eye to, if not invites, accidental and intentional misuse.
CRN has taken the right path here. We are protecting our consumers from a safe ingredient that becomes dangerous when sold in a bulk pure powdered form directly to consumers. CRN has chosen to put public safety first and we urge other companies to demonstrate that ours is a responsible, mature industry that self-polices as well as knows when to work with our regulators. It’s time to wake up and smell the coffee.