Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

Atlantic Trading Co., Inc. Weston, FL (7/8). Examined the product label in January and the Web site in June. Unapproved new drug, misbranded. The Web site promotes the firm’s Atlantic Salmon Boneless Skinless Center Cut Fillets product for conditions that cause the product to be a drug. For example, it makes the claims: “Omega-3s…lower triglycerides, reduce abnormal heart rhythms, reduce blood pressure…” (Atlantic Salmon Boneless Skinless Center Cut Fillets); FDCA 403(r)(1)(B)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm408707.htm

Dean and Jean Mikalunas Farm Sherburne, NY (7/31). Inspected 4/9 and 4/21. Violations, adulterated: The dairy adulterated the new animal drug (purged) (ceftiofur sodium sterile powder) in that it did not use it as directed by its approved labeling or by a servicing veterinarian’s prescription. The dairy administered the drug to its dairy cows without following the recommended withdrawal time (four days) from slaughter as stated on the approved labeling (ceftiofur sodium sterile powder); FDCA 501(a)(5)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm407846.htm

Dr. Bronner’s Magic Soaps Escondido, CA (7/8). Reviewed in January the label for Dr. Bronner’s Magic “All-One!” Fresh-Pressed Virgin Coconut Oil and has determined that the product is promoted for conditions that cause it to be a drug. For example, the following claim is made on the product label: “Clinical research confirms that the saturated medium chain fatty acids (MCT’s) in [Virgin Coconut Oil], such as lauric acid, actually improve blood cholesterol by increasing the ratio of HDL to LDL cholesterol,” etc. (Dr. Bronner’s Magic “All-One!” Fresh-Pressed Virgin Coconut Oil); FDCA 505(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm408739.htm

Healthtime dba Deer Garden Foods Hollister, CA (7/24). Reviewed Web sites at www.rejuvenative.com, www.rawoils.com, www.rejuvenative.com, in June. The Web site promotes products for conditions that cause them to be drugs. For example, the 100% Organic Evening Primrose Oil Web page makes claims such as “Fight damage caused by multiple sclerosis” and “Reduce the symptoms of eczema,” etc. (100% Organic Evening Primrose Oil, Spicy Kim-Chi, Fresh Raw Almond Butter, and “Organic Ginkgo Green Caffeine Tea); FDCA 505(a), 502(f)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm408105.htm

M.D. Science Lab Pompano Beach, FL (7/15). Inspected 9/18-10/3/13. GMP violations, adulterated: The firm failed to implement quality control operations in its packaging, labeling, and holding operations for producing dietary supplements to ensure the quality and to ensure that they are packaged and labeled as specified in the master manufacturing record. Also, the firm has not established specifications for the labels and packaging used with the dietary supplement products nor does it have written procedures for the packaging and labeling operations, etc. (dietary supplements); FDCA 402(g)(1), 21 CFR 111.65, 111.70(g), 111.403, 111.70(f), 111.453, 111.520, 111.553, 111.70(d), 111.83(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm407845.htm

ProTech Professional Products, Inc. Boynton Beach, FL (7/24). Inspected 12/11-13/13. QSR deviations, adulterated, misbranded, unapproved device: The firm made significant modifications to its denture base resins. It currently uses a different process during the manufacturing process than the process cleared by FDA in its 510(k). It also uses the coloring components Pigment Red 187, Pigment Yellow 180, and Pigment Red 149, but the 510(k) clearance lists the colorant components only as FD&C Red 40. The firm has no written design control procedures for the ProTech Plus Self Cure Hard Reline and Repair Acrylic Powder and Liquid devices, including not having documentation of requirements for the labeling of the products, etc. (ProTech Plus Self Cure Hard Reline and Repair Acrylic Powder and Liquid devices); FDCA 501(f)(1)(B), 515(a), 502(o), 21 CFR 820.30(a)(1), 820.50, 820.100(a)(2)&(4), 820.198(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm407468.htm