Hard Eight Nutrition LLC 8/27/15
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||College Park, MD 20740|
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
Hard Eight Nutrition, LLC
7511 Eastgate Road
Henderson, NV 89011
AUG 27 2015
Dear Mr. Baronowsky:
This is to advise you that in August 2015, the U.S. Food and Drug Administration (FDA) reviewed the label for your Caffeine Powder product, which is labeled and offered for sale as a dietary supplement on your website, www.bulksupplements.com. Your product is offered in powdered form in package sizes ranging from 100 grams to 25 kilograms. We have reviewed the product labeling for your 100 gram package, which lists the substance caffeine anhydrous as the sole ingredient.
Based on our review, we have determined that your Caffeine Powder 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, "As a dietary supplement, take 50 mg to 200 mg (1/16 tsp) up to three times daily." Your label also includes a chart entitled, “U.S. Standard Measuring Spoons” that reads as follows:
Spoon Size (level)
It is unclear why your product label provides information regarding an eighth of a teaspoon and a quarter of a teaspoon, since both of these measurements are well in excess of the maximum serving size that your label recommends. Although your directions say to take 50 milligrams to 200 milligrams of the product at a time, it is possible that a consumer would understand your label as a whole as suggesting a serving size of one-eighth of a teaspoon or one-quarter of a teaspoon.
Furthermore, to the extent that your label suggests a serving size of 50 milligrams to 200 milligrams (1/16 tsp), and the information regarding various fractions of a teaspoon is meant to help the consumer accurately administer a serving in this range, these suggested conditions of use present a significant or unreasonable risk of illness or injury. Your product label appears to suggest that consumers may use a one-sixteenth teaspoon (and perhaps a 1/8 teaspoon or a 1/4 teaspoon) to measure a serving of 50 milligrams to 200 milligrams.
Consumers are unlikely to have a one-sixteenth teaspoon measuring tool, as this tool is not generally available in standard consumer measuring spoon sets. Even if such a tool were available, it would be difficult to use it to measure a 50 milligram serving of your product, as 50 milligrams is approximately one-quarter of a one-sixteenth teaspoon measuring tool based on the numbers on the chart you provided. Consumers are much more likely to have a one-quarter or a one-eighth teaspoon measuring tool. However, based on the numbers you provide, a 50 milligram serving of your product would be 6.6% of a one-quarter teaspoon and 13.2% of a one-eighth teaspoon. A 200 milligram serving would be 26.5% and 53% of the teaspoons, respectively. These amounts cannot be accurately measured using these tools.
Caffeine is a powerful stimulant. A single teaspoon of pure powdered caffeine is roughly equivalent to the amount in 28 cups of coffee
(approximately 2.7 grams
). 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 product consists of a package containing 100 grams (approximately 12 tablespoons) of powdered caffeine, which is 500-2000 recommended servings of the product. (We furthermore note that this is the smallest size in which you package your product; your 25 kilogram product size contains 125,000-500,000 recommended servings of the product.) The conditions of use suggested by your labeling appear to imply that certain common household measuring tools can be used to accurately measure the recommended serving size of your product, when in fact those tools cannot be used to accurately measure the recommended serving size. In light of the potential toxicity of your product; the fact that your product is packaged to contain an amount that would be lethal to many consumers; the fact that the packaging requires the consumer to separate out a safe serving from this potentially lethal amount; and the fact that the product labeling incorrectly implies that this process of separating out a safe serving from a potentially lethal amount can be done with certain common household measuring tools, when in fact it would require a precise scale; 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.
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, 5100 Paint Branch Parkway, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions, please contact Mr. Goldman at PowderedCaffeine-CFSAN@fda.hhs.gov
William A. Correll
Office of Compliance
Center for Food Safety
and Applied Nutrition
 Due to the nature of producing a powdered crystalline substance, there may be differences in the density of different caffeine powders 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. We have used these numbers in this paragraph and the following paragraph rather than the chart provided on the product label.