The United Natural Products Alliance instituted a “no sale” policy for members regarding bulk caffeine. Similarly, the American Herbal Products Alliance announced a “trade requirement” that prohibits the sale of the ingredient for AHPA members. The Council for Responsible Nutrition contacted NutraIngredients-USA to say that it will announce a policy on the ingredient on Thursday.
Significant overdose risk
Bulk caffeine powder has been for sale on websites for some time such as bulksupplements.com. The sale page for the ingredient on that site contains a prominent warning, citing the toxicity risk with too much caffeine, and recommends that consumers not use more than 200 mg at a time or more than 600 mg in a day. But such warnings don’t address the primary safety issue with the ingredient. The powders are pure caffeine, a highly potent substance, and the suggested serving size is so tiny in a physical sense that it would be difficult for the average consumer to mete out a safe dose with typical home kitchen measuring equipment. According the Center for Science in the Public Interest, which has called on FDA to ban the sale of the ingredient, one teaspoon of the caffeine powder mixed into a beverage would equate to drinking about 25 cups of coffee. That couples with the target audience for these products—teenagers or highly amped workout devotees—a demographic not known for restraint, to create what advocates say is a clear and present health risk to consumers. (The two reported deaths involved two young men, ages 18 and 24.)
In late December last year the agency did issue an advisory on the ingredient. Six US Senators supported CSPI's call for a ban in a letter sent to FDA in January.
Putting all that together, it was high time that trade organizations stepped up to the plate, said Frank Lampe, vice president of communications and industry relations for UNPA.
“The big issue is that based on the cases we are familiar with, including the death and injury reports, the recommended dosage is something like one-sixteenth of a teaspoon. They don’t make measuring spoons like that. It leaves consumers exposed to overdosing on what is already a very powerful stimulant,” Lampe said.
“As part of a responsible industry we don’t think this ingredient should be offered to consumers in this form. People like caffeine, and there are plenty of ways for consumers to get caffeine in a safe form,” he said.
Besides the obvious routes of naturally caffeinated drinks such as tea and coffee, many products such as energy drinks and even some energy bars offer added caffeine. And for consumers who want to caffeinate their favorite non caffeinated beverage or food product, the supplement company Fein offers a form of buffered, de-bittered powdered caffeine in stick packs that contain a single, safe dose.
FDA has authority to act
Lampe said that UNPA believes FDA has ample authority to act in the case. The agency has used this authority before, under DSHEA’s "significant or unreasonable risk of illness or injury" provision, which was exercised by the agency in 2004 to remove ephedra from the market.
Lampe admitted that UNPA’s announcement of the policy was an easy win, as none of its members currently sell the ingredient. But it’s important to demonstrate to the wider industry and to the public in general is leading on the issue, he said.
“This is similar to the action that we took to institute a ‘no sale’ policy on kratom as a condition of membership. We are trying to get out in front of what we see as a potentially significant problem. We are trying to reduce the opportunity for any more of these incidents to occur,” Lampe said.