Kreativ Health Inc Dba Natural Food Supplements 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
Ronald L. Rudnuck, President
Kreativ Health Inc. dba Natural Food Supplements
8725 Remmet Ave., Unit B
Conoga Park, CA 91304
AUG 27 2015
Dear Mr. Rudnuck:
This is to advise you that in August 2015, the U.S. Food and Drug Administration (FDA) reviewed the label for your Sunshine Valley Caffeine Powder product, which is labeled and offered for sale as a dietary supplement on the website, www.aonevitamins.com. Your product is offered in powdered form, and its labeling lists the substance caffeine anhydrous as the sole ingredient.
Based on our review, we have determined that your Sunshine Valley 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 to 200 mg up to three times daily. Use a milligram scale for accurate measurement." Depending on the density of the powder, we estimate that a serving of 200 milligrams would be approximately 1/14th
of a teaspoon..
These amounts 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. A 50-milligram dose would of course be considerably smaller in volume.
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 Sunshine Valley Caffeine Powder product consists of a package containing 14.15 grams (approximately 1.7 tablespoons) of powdered caffeine, which is approximately 70-280 servings of the product. In light of the potential toxicity of your product; the fact that your product is packaged to contain an amount that would be potentially lethal to many consumers; 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.
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 Mabel Lee, 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 Ms. Lee 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 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.