Warning letters were issued to
Jeffrey Stratton
Bridge City Bulk
Bridge City LLC
3519 NE 15th Avenue, #420
Portland, OR 9721
Kevin Baronowsky
Hard Eight Nutrition, LLC
7511 Eastgate Road
Henderson, NV 89011
Ronald L. Rudnuck, President
Kreativ Health Inc. dba Natural Food Supplements
8725 Remmet Ave., Unit B
Canoga Park, CA 91304
Timothy McNulty
Purebulk, Inc.
1640 Austin Road
Roseburg, OR 97471
Michael McCandless
SPN, LLC dba Smartpowders
1130 Cherry Lane
Graham, NC 27253
Sample of letter
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.