34748 Pecan Ave
Yucaipa, CA 92399
- Issuing Office:
- Center for Food Safety and Applied Nutrition
| || |
10903 New Hampshire Avenue
Silver Spring, MD 20993
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
May 29, 2018
Dear Mr. Feenstra:
This is to advise you that in January 2018, the U.S. Food and Drug Administration (FDA) purchased your Liquid Caffeine product and reviewed its label. Also, in March 2018, FDA reviewed your website, www.liquidcaffeine.com
, where your Liquid Caffeine product is labeled and offered for sale as a dietary supplement.
Based on our review, we have determined that your Liquid Caffeine product is adulterated within the meaning of section 402(f)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(f)(1)(A)(i)] because it is a dietary supplement that presents a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling. You can find the Act and FDA regulations through links in FDA’s home page at http://www.fda.gov
The directions on your product’s label state that one pump equals 83 mg of caffeine, or one tsp; that two pumps equals 166 mg of caffeine, or two tsp; and that three pumps equals 250 mg of caffeine, or three tsp. In addition to this labeling, you have provided a measuring cup for your product. This measuring cup is labeled as being one fl. oz.
One fluid ounce of liquid is approximately two tablespoons or six teaspoons. Based on the amounts listed on your label this would be approximately 500 mg of caffeine. There is a significant danger that consumers may consider this cup to be one serving of your product, since it is included as a measuring device and they may not be able to determine the conversion between the milligram and teaspoon serving sizes listed on your label and the fluid ounce measurement provided on your measuring cup. The directions for use stating to use “pumps” does not cure this problem of customers potentially assuming that the measuring cup is a single serving, because you do not include a pump with your product. While a pump is available as a separate purchase on your website, not all consumers will purchase this additional product while using your product. Therefore, those customers would be unable to follow your directions regarding “pumps” on your product label, and might instead use the measuring cup you provide under the assumption that it holds a single serving, when in fact it contains 6 “one-pump” servings.
Caffeine is a powerful stimulant. Due to the saturable metabolism of caffeine, its consumption in servings that are in excess of 500 mg could increase its half-life, potentially causing an individual to feel its effects quickly and for an extended period of time. The toxic effects of caffeine – including chest pain, hypokalemia, elevated blood glucose, tachycardia, bigeminy, agitation, respiratory alkalosis, and irregular heartbeat – occur beginning at approximately 1.2 grams of caffeine, or slightly more than two servings using the measuring cup you provide with your product. A life-threatening dose of caffeine is typically estimated at between 10 and 14 grams, though a smaller amount can be life-threatening in children and sensitive populations.
The entire package of your product is sold as containing 16 ounces (though this total packaged amount is not stated on the product label), which means that this package contains approximately eight grams of caffeine. Therefore, your 16 ounce product contains multiple toxic doses, and as a whole it represents an amount of caffeine that could be potentially lethal to certain populations. In light of the potential toxicity of your product; the fact that your product is packaged to contain an amount that would be toxic several times over, and potentially lethal to certain consumers; the fact that the packaging requires the consumer to separate out a safe serving from this potentially toxic amount; the fact that the product labeling incorrectly implies that this process of separating out a safe serving from a potentially toxic amount can be done with a pump, which is not in fact sold with the product; and the fact that the product is instead co-packaged with a measuring device that holds 6 “one-pump” servings of your product, but is labeled with a different unit of measurement from the directions, such that consumers might not understand how many servings it contains and assume that it contains one serving; we have determined that your product presents a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling.
Moreover, a review of your website also shows that you sell a similar-appearing product containing two gallons of liquid caffeine. While we have not reviewed the labeling for this product, if it is similarly labeled, this product would present the same issues as your 16 ounce product, with the added risk that a two gallon container contains approximately 128 grams of caffeine, which is many potentially lethal doses.
The above violations are not intended to be an all-inclusive list of violations that exist in connection with your products. You are responsible for ensuring that all of your products are in compliance with the Act and all applicable FDA regulations. You should take prompt action to correct the violations cited above and to prevent their reoccurrence. Failure to do so may result in legal action without further notice, including seizure and/or injunction.
Please respond in writing within fifteen (15) working days of receipt of this letter. Your response should outline the specific steps you have taken to correct these violations, including any steps taken with respect to product currently in the marketplace. Your response should also include an explanation of steps you have taken to ensure that similar violations do not recur, as well as documentation to support your response. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Your written reply should be directed to Shawn Goldman, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions, please contact Mr. Goldman at Shawn.Goldman@fda.hhs.gov
William A. Correll
Office of Compliance
Center for Food Safety
and Applied Nutrition