Inspections, Compliance, Enforcement, and Criminal Investigations

Smartpowders 8/27/15

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 College Park, MD 20740

 

WARNING LETTER
 
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
 
 
Michael McCandless
SPN, LLC dba Smartpowders
1130 Cherry Lane
Graham, NC 27253
 
AUG 27 2015
 
Re: 470577
 
Dear Mr. McCandless:
 
This is to advise you that in August 2015, the U.S. Food and Drug Administration (FDA) reviewed the label for your Caffeine Anhydrous 400 Grams product, which is labeled and offered for sale as a dietary supplement on your website, www.smartpowders.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 Caffeine Anhydrous 400 Grams 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 label states:
“Serving Size: 200mg
Servings per container: 2000
¼ Teaspoon: 574mg”
 
It is unclear why your product label provides the information that one-quarter teaspoon of your product is 574 milligrams, since this amount is well in excess of the serving size that your label recommends.  Although your product’s serving size is listed as 200 milligrams, it is possible that a consumer would understand your label as a whole as suggesting a serving size of one-quarter teaspoon.
 
Furthermore, to the extent that your label suggests a serving size of 200 milligrams and the information regarding a one-quarter teaspoon is meant to help the consumer accurately administer a serving of 200 milligrams, these suggested conditions of use present a significant or unreasonable risk of illness or injury. Your product label appears to suggest that consumers can use a one-quarter teaspoon to measure a serving of 200 milligrams.  While consumers are likely to have a one-quarter teaspoon measuring tool, a 200-milligram dose would be 34.8% of a one-quarter teaspoon, based on the information on your label.  This amount cannot be accurately measured using a one-quarter teaspoon measuring tool.
 
Caffeine is a powerful stimulant.  A single teaspoon of pure powdered caffeine is roughly equivalent to the amount in 28 cups of coffee[1] (approximately 2.7 grams[2]).  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 400 grams (approximately 49 tablespoons) of powdered caffeine, which is 2000 recommended servings of the product. The conditions of use suggested by your labeling appear to imply that a one-quarter teaspoon measuring tool can be used to accurately measure the recommended serving size of your product, 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 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 a common household measuring tool (a one-quarter teaspoon), 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 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.
 
 
Sincerely,
/s/                                                                       
William A. Correll
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
 


[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/4277 
 
[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. We have used these numbers in this paragraph and the following paragraph rather than the 573 mg to a 1/4 teaspoon conversion provided on the product label.

 

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