Inspections, Compliance, Enforcement, and Criminal Investigations

Dual Health Body and Mind 5/29/18

 

  

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10903 New Hampshire Avenue
Silver Spring, MD 20993 

 

WARNING LETTER
 
 
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
 
May 29, 2018
 
Dual Health Body and Mind
188 5th Creek Road
Statesville, NC 28625
 
Re: 545453
 
Dear Ms. Walter:
 
This is to advise you that in January 2018, the U.S. Food and Drug Administration (FDA) reviewed the label for your 8 ounce Caffeine Anhydrous Powder product, which is labeled and offered for sale as a dietary supplement on your website, http://dualhealthsupplements.com.  We further reviewed your website in March 2018. Your product is offered in powdered form, and its labeling lists “100% pure Caffeine Powder” as the sole ingredient.
 
Based on our review, we have determined that your 8 ounce Caffeine Anhydrous 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.
 
Your 8 ounce Caffeine Anhydrous Powder product label states, “Recommended Dose: 1/16 teaspoon (200mg). Servings: Take 1-3 times daily.” 
 
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. Even if consumers were to have a 1/16 teaspoon measuring tool, as you suggest be used on your labeling, it would still not be adequate to accurately measure a 200 milligram serving because this tool can deliver a different amount depending on factors such as how tightly the powder is packed and whether a “heaping” scoop is used.  Furthermore, a simple mistake such as measuring a serving in grams or fractions of a tablespoon, rather than milligrams or fractions of a teaspoon, 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 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 Caffeine Anhydrous Powder product consists of a package containing 8 ounces of powdered caffeine, which is approximately 227 grams.  This is well over a thousand servings of your product, using your recommended serving size of 200 milligrams. (We also note that you sell your product in packages as large as 5.5 pounds, which is approximately 2,500 grams, and almost 12,500 servings of the product.) The conditions of use suggested by your labeling appear to imply that consumers have ready access to either a very precise scale or a 1/16 teaspoon measuring tool, and that a 1/16 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 is potentially lethal many times over; the fact that the packaging requires the consumer to use a precise scale to separate out a safe serving from this potentially lethal amount; and the fact that your product labeling could be read to incorrectly imply that this process of separating out a safe serving from a potentially lethal amount can be done with certain volume measuring tools; 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 3.5 ounces to 5.5 pounds. While we have not reviewed these products, if they are similar to your 8 ounce product they would present the same issues as that product, with the added risk that the products larger than your 8 ounce product contain even more 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.
 
 
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/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. We have used these numbers in this paragraph and the following paragraph rather than the 200 mg to a rounded 1/32 teaspoon conversion provided on the product label.

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