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WARNING LETTER

March 10, 2021

Re: 612586

Dear Mr. Azhar:

This is to advise you that in January 2021, the U.S. Food and Drug Administration (FDA) reviewed the label for your 16-ounce Super Caffeine (Anhydrous) product, which is labeled and offered for sale as a dietary supplement on your website http://www.wholesalecentral.com/trippo/store.cfm. Your product appears to be offered in powdered form, and its labeling lists “caffeine anhydrous” as the sole ingredient.

Based on our review, we have determined that your 16-ounce Super Caffeine (Anhydrous) 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.

Your 16-ounce Super Caffeine (Anhydrous) product label states, “Serving Size: 200 milligrams Total Servings Per Container 2267.” The directions on your product label further state, “Recommended use 200mg up to 2 times daily. Allow 3 to 4 hours between servings. Do not exceed more than 400 mg for 2 doses per day.”

A serving size of 200 milligrams cannot be accurately measured using common household measuring tools. Many consumers do not have a scale that is sufficiently precise to accurately measure such a small amount. Furthermore, a simple mistake such as measuring a serving in grams, rather than milligrams, could result in a dangerous or even toxic dose.

Caffeine is a powerful stimulant. A single teaspoon of pure powdered caffeine is roughly equivalent to the amount in 28 cups of coffee¹ (approximately 2.7 grams²). Consuming as little as one teaspoon of caffeine has been associated with symptoms including nausea, vomiting, anxiety, and heart palpitations. Consuming as little as one tablespoon (equivalent to 3 teaspoons or approximately 8.1 grams) of caffeine has been associated with symptoms including chest pain, hypokalemia, elevated blood glucose, tachycardia, bigeminy, agitation, respiratory alkalosis, irregular heartbeat, and in some cases, even death.

Your 16-ounce Super Caffeine (Anhydrous) product consists of a package containing 16 ounces of powdered caffeine, which is approximately 454 grams. This is over 2,000 servings of your product, using your recommended serving size of 200 milligrams. The conditions of use suggested by your labeling appear to imply that consumers have ready access to a very precise scale, when in fact that is not the case. In light of the potential toxicity of your product; the fact that your product is packaged to contain an amount that is potentially lethal many times over; and the fact that the packaging requires the consumer to use a precise scale to separate out a safe serving from this potentially lethal amount; 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 similar-appearing products in package sizes ranging from 1 ounce to amounts less than 16 ounces. Based on the information we have reviewed for these products they appear to be similar to your 16-ounce product and would thus present the same issues. Even your 1-ounce product appears to contain well over 100 servings, a potentially lethal amount.

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written reply should be directed to [email protected].

Sincerely,
/S/

William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration

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1 The USDA nutrition database reports that one cup (8 oz) of ground coffee contains 95 mg of caffeine: http://ndb.nal.usda.gov/ndb/foods/show/4287.

2 Due to the nature of producing a powdered crystalline substance, there may be differences in the density of different powdered caffeine products even when the products are the same chemical substance. Our reported values for a teaspoon and tablespoon of powdered caffeine are based on peer reviewed literature, which indicates that the poured bulk density of powdered caffeine is 0.55 g/mL and therefore one standard teaspoon is 2.7 g and one standard tablespoon is 8.1 g.