FDA Webview
X

Free Warning Letters

Latest FDA Warning Letters

03/03/2015

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

cancerherbtea.com Deltona, FL (2/26) Reviewed Web sites www.cancerherbtea.com and www.anamucancerherbtea.com 12/2014. Misbranded: The therapeutic claims on the Web sites establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease, etc. (Anamu CancerHerb Tea Box, Anamu CancerHerb Tea Box with Honey, and Organic Bottled Tea Drinks); FDCA 502(f)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435681.htm


Canna Companion LLC Sultan, WA (2/24) Reviewed product labeling and Web site at www.cannaforpets.com. Unapproved new animal drug, adulterated: The home page makes statements such as “Here’s how Canna Companion may help your dog or cat: Reduce cancer-associated symptoms, Aid in decreasing severity of dementia, and Reduce bronchial spasms in asthmatics,” (Canna Companion); FDCA 512(a), 501(a)(5), 301(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435671.htm


Canna Pet LLC Seattle, WA (2/24) Reviewed product labeling and Web site at www.canna-pet.com. Unapproved new animal drugs, adulterated: The Web site makes statements such as “We Recommend Canna-Pet as a daily food additive for all pets, but especially for those with arthritis, allergies, anxiety or behavior issues, compromised immune systems, diabetes, digestive issues, nausea, chronic pain, cancer, seizures, and those receiving palliative care,” etc. (Canna-Pet for Cats, Canna-Pet for Dogs, Canna-Pet MaxCBD Capsules, and Canna-Biscuits for Dogs); 512(a), 501(a)(5), 301(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435662.htm


CBD Life Holdings LLC dba Ultra CBDScottsdale AZ (2/26) Reviewed Web site at www.ultracbd.com 11/2014. Misbranded: FDA also reviewed literature that accompanies the sale and shipment of Ultra CBD and has determined that the Web site and the literature promote it for conditions that cause the product to be a drug, etc. (Ultra CBD); FDCA 502(f)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435778.htm


Hemp Oil Care Los Angeles, CA (2/26) Reviewed Web site at https://www.hempoilcare.com 11/2014. Unapproved new drugs, misbranded. Claims are made that make the products unapproved new drugs. For example, on the “CBD Oil” Web page it states: “[A study] suggests that cannabinoids could help treat pancreatic adenocarcinoma – one of the most aggressive forms of cancer,” etc. (Cibdex Hemp CBD Complex Drops, Cibaderm Hemp Salve, Dixie Botanicals Dew Drops Hemp Oil Supplement, Hemp Honey 21% Cannabidiol Oil, Hemp Honey CBD Vape Oil, and “Hemp Pure Vape E-Drops); FDCA 505(a), 502(f)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436069.htm


Infiniti Creations Inc. Lindon, UT (2/26). Reviewed Web site at www.curadermcream.com (redirected to: www.bec5creamdirect.com).Products are unapproved new drugs because they are intended to prevent, treat, or cure disease. FDCA 505(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436079.htm


Modern Herb Shop Sacramento, CA (2/26). Reviewed Web site at http://www.modernherbshop.com/ in February. Web site promotes products for conditions that cause them to be unapproved new drugs, etc. (Bone Knitting Powder, Bu Zhong Yi Qi Wan | Central Chi Teapills, Burn Ointment | Ching Wan Hung Soothing Herbal Balm, Chuan Xin Lian, Huang Lian Su, San Huang San | Herbal Ice, Si Miao San Herb Extract Powder, Wu Yang Brand Pain Relieving Medicated Plaster, Yunnan Baiyao Capsules and Powder, and Zheng Gu Shui); FDCA 505(a), 502(f)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436074.htm


NanoBiotech Pharma Orlando, FL (2/26). Reviewed Web sites at http://www.nanobiotech.us, http://www.nanobiotech.squarespace.com, and http://www.nanobiotechpharma.com 12/2014. The Web sites promote for conditions that cause the products to be drugs. They also cite articles on the use of NanobacTX and Urobac products to treat diseases, etc. (NanobacTX and Urobac); FDCA 505(a), 502(f)(1) http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435675.htm


Natural Organic Solutions Olympia, WA (2/26). Reviewed Web site at www.purecbd.net and the Etsy.com marketplace store at www.etsy.com/shop/PureCBD in February. FDA has determined that the Web sites and accompanying literature promote their products for conditions that cause them to be drugs, etc. (CBD Hemp Oil Treatment, Hemp CBD (Cannabidiol) Extract Capsules, CBD Extract Capsules Anti Anxiety Formula, and High CBD Healing Salve); FDCA 505(a), 502(f)(1) http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436066.htm


Nutreglo Products, Inc. Miramar, FL (2/26). Reviewed Web sites at http://nutregloproducts.com 12/2014. Misbranded: The Web site promotes the products for conditions that cause them to be drugs. Labeling fails to bear adequate directions for use, etc. (Sour Sop (Guanabana) Graviola, Moringa (Oleifera), and Guinea Hen weed (Anamu) petiveria); FDCA 505(a), 502(f)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435680.htm


Perry Drug Inc. Overland Park, KS (2/3). Inspected 8/26-29/14 and 9/4-9/14. Adulterated, misbranded: The investigator observed serious deficiencies in the firm’s practices for producing sterile drug products. Materials and components are not disinfected before introduction into the ISO 5 area. The investigator also noted that the firm produces domperidone drug products. Domperidone is not the subject of an applicable USP or National Formulary monograph, nor is it a component of an FDA-approved human drug product, etc. (compounded drugs); FDCA 501(a)(2)(A-B), 505(a), 502(f)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435642.htm

Twin Falls Bio Tech, LLC Hilton Head Island, SC (2/26). Reviewed www.arisitol.com 11/2014. FDA also reviewed literature that accompanies the sale and shipment of Arisi-Tol and has determined that they promote it for conditions that cause the product to be a drug, etc. (Arisi-Tol); FDCA 502(f)(1), 505(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435777.htm


LATEST NEWS