Inspections, Compliance, Enforcement, and Criminal Investigations

Bridge City LLC 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
 
 
Jeffrey Stratton
Bridge City Bulk
Bridge City LLC
3519 NE 15th Avenue, #420
Portland, OR 97212
 
AUG 27 2015
 
 
Re: 470576
 
 
Dear Mr. Stratton:
 
This is to advise you that in August 2015, the U.S. Food and Drug Administration (FDA) reviewed the labeling for your Caffeine Anhydrous Natural Coffee Bean product and your Caffeine Powder (Synthetic Anhydrous) product, which are labeled and offered for sale as dietary supplements on your website, www.bridgecitybulk.com.  Your Caffeine Anhydrous Natural Coffee Bean product is offered in powdered form in package sizes ranging from 1 kg to 25 kg, and your Caffeine Powder (Synthetic Anhydrous) is offered in powdered form in package sizes of 10 kg and 25 kg.  The labeling of your Caffeine Anhydrous Natural Coffee Bean and Caffeine Powder (Synthetic Anhydrous) products lists the substance “Caffeine Anhydrous” as the sole ingredient.
 
Based on our review, we have determined that both of these products are 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 they are dietary supplements that present 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 website labeling for each of these two products states, "Serving Size: 200 milligrams.”  Your website also includes a picture of a 1 kg Caffeine Powder (Synthetic) Caffeine Anhydrous label that includes the following directions: “As a dietary supplement, take 50 to 200 mg up to three times daily.  Use an accurate milligram scale for measurement.”  Depending on the density of the powder, we estimate that a serving of 200 milligrams would be approximately 1/14th of a teaspoon.[1].  This amount 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.
 
Caffeine is a powerful stimulant.  A single teaspoon of pure powdered caffeine is roughly equivalent to the amount in 28 cups of coffee[2] (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 Caffeine Anhydrous Natural Coffee Bean in a 1 kg package contains approximately 123 tablespoons of powdered caffeine, which is equivalent to 5,000 servings of the product, and your Caffeine Powder (Synthetic Anhydrous) in a 10 kg package contains approximately 1,230 tablespoons of powdered caffeine, which is equivalent to 50,000 servings of the product.  In light of the potential toxicity of your products; the fact that both products are packaged to contain an amount that would be 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 lethal amount; we have determined that your product presents a significant and 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
 
 
cc:
Jeffrey Stratton
Bridge City Bulk/Bridge City LLC
320 NE Failing Street
Portland, OR 97212


[1] 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.
 
[2] 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 

 

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