The United Natural Products Alliance (UNPA) has approved the adoption of a new, “no-sale” policy for liquid, high-dose caffeine products for retail sales.
The policy is effective immediately as a condition of membership for prospective and all current UNPA members and joins a 2015 no-sale policy for bulk-powdered caffeine products. UNPA recommends that high-dose caffeine products not be advertised, sold or marketed as a dietary supplement for retail sale or exhibited at trade shows.
The action follows a Food and Administration (FDA) guidance published in the Federal Register on April 16, 2018, alerting industry and consumers that it considers some dietary supplements consisting of “only or primarily pure or highly concentrated caffeine to be adulterated.” The guidance further notes that these products “are often sold in bulk containers with hundreds or thousands of servings in the container, and even a small dose can be toxic or deadly” and thus pose a significant or unreasonable risk of illness or injury.
UNPA commended this new action as a logical next step in FDA’s efforts to inform consumers about the health risks associated with the consumption of high-dose caffeine products.
“FDA’s April 2018 guidance brought to our attention its concern over liquid, high-dose caffeine products, and it’s only appropriate that UNPA now follows FDA’s lead by creating this no-sale policy for these products,” said Loren Israelsen, UNPA president. “The potential for harm is high enough that we felt it that this expanded policy is appropriate.”
In 2015 and 2016, FDA issued warning letters to seven distributors of pure powdered caffeine and reported at least two deaths and an unknown number of medical events attributable to consumption of bulk powdered caffeine sold through retail venues.
The new policy regarding liquid, high-dose caffeine joins the following “no-sale” trade policies enacted by UNPA:
- April 9, 2015: no β-methylphenethylamine (BMPEA) sales
- 24, 2015: no bulk-powdered caffeine for retail sale
- May 1, 2014: no sale, distribution or marketing of any products that contain kratom (Mitragyna speciosa) for human use or consumption
- May 1, 2013: no sale of 1,3-dimethylamylamine, methylhexanamine or geranium extract, commonly known as DMAA, or any chemically related substance
- May 1, 2005: no sale, distribution or marketing of any products containing ephedra or ma huang (Ephedra sinica) at any dose.
For more information, visit www.unpa.com.