Inspections, Compliance, Enforcement, and Criminal Investigations

PureBulk 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
 
Timothy McNulty
Purebulk, Inc.
1640 Austin Road
Roseburg, OR 97471
 
AUG 27 2015
 
Re: 470586
 
Dear Mr. McNulty:
 
This is to advise you that in August 2015, the U.S. Food and Drug Administration (FDA) reviewed the label for your Caffeine Powder (Synthetic) product, which is labeled and offered for sale as a dietary supplement on your website, www.purebulk.com.  Your product is offered in powdered form in package sizes ranging from 25 grams to 25 kilograms.  The 25 gram product is currently out of stock as of our most recent review of your website. We have reviewed the product labeling for your 25 gram product, which lists the substance caffeine anhydrous as the sole ingredient.
 
Based on our review, we have determined that your Caffeine Powder (Synthetic) 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 25 gram Caffeine Powder (Synthetic) product label states, “Serving Size: 200 milligrams Servings Per Container: about 125.”  The directions also describe 200 mg as a “rounded 1/32 tsp” and state that an “[a]ccurate measurement of caffeine powder…may be performed with a digital gram weight scale precise to 0.01 grams (10mg) or better.”
 
It is unclear why your product label provides information regarding a “rounded” 1/32 teaspoon; consumers are unlikely to have a 1/32 teaspoon measuring tool, as this tool is not generally available in standard consumer measuring spoon sets.  Consumers are much more likely to have a one-quarter or a one-eighth teaspoon measuring tool.  A serving size of 200 milligrams cannot be accurately measured using these common household measuring tools.  Even if consumers were to have a 1/32 teaspoon measuring tool, it would still not be adequate to accurately measure a 200 milligram serving because this tool can deliver a different amount depending on how tightly the powder is packed.  Furthermore, many consumers do not have a scale that is sufficiently precise to accurately measure such a small amount.
 
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 Powder (Synthetic) product consists of a package containing 25 grams (approximately 3 tablespoons) of powdered caffeine, which is 125 recommended servings of the product.  (We furthermore note that this is the smallest size in which you package your product; by contrast, your 25 kilogram product size contains 125,000 recommended servings of the product.) The conditions of use suggested by your labeling appear to imply that a 1/32 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 potentially lethal to many consumers; 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.
 
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.
 
 
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 200 mg to a rounded 1/32 teaspoon conversion provided on the product label.

 

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