Sunny Creek Farm, Inc.
FDA issued a warning letter to Sunny Creek Farm, Inc. (Tryon, NC) following an August 2021 inspection that found serious violations of the Produce Safety Rule, including distributing sprouts after pathogen-positive test results and inadequate sanitation of food contact surfaces. Additionally, FDA reviewed the company's website and determined that marketing claims for broccoli sprout products — including claims that they treat cancer, Alzheimer's, heart disease, autism, and schizophrenia — rendered those products unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act. The company was directed to respond within 15 working days with corrective actions, and FDA warned that failure to comply could result in seizure or injunction.
Flagged claims (8)
Interestingly, several studies involving children with autism and sulforaphane also were shown to reduce symptoms by 26%. Another study with people who have symptoms of schizophrenia… their symptoms were reduced by 25%.
One of the best chemoprotective nutrients from cruciferous vegetables that prevents the…growth of tumors is sulforaphane… Broccoli sprouts are one of the best foods for the bioavailability of sulforaphane.
An important aspect of the compound [sulforaphane] is that it crosses the blood brain barrier and protects against neurodegenerative diseases; it also protects against cardiovascular disease and helps fight cancer.
…here's what I think how eating broccoli sprouts all these years has prevented me from having Alzheimer's…
Cruciferous vegetables, including broccoli, and in particular broccoli sprouts, have thus been hypothesized to play a role in the amelioration of gastritis, peptic ulcer disease, and stomach cancer as well as a variety of oxidative and degenerative conditions. This includes cancers, at a variety of organ sites, as well as working to repair age-related macular degeneration, and hypertension.
8 Nutrients That Block Cancer Metastasis… Eat to starve cancer by feeding your body the 8 nutrients listed below to stimulate apoptosis in cancer cells, prevent angiogenesis and consequently inhibit tumor formation and cancer metastasis to other areas of the body... 5. Sulforaphane It is found in broccoli sprouts and other cruciferous vegetables like cauliflower, broccoli, brussels sprouts, and kale.
Broccoli Sprouts… How the epigenetic benefits of eating broccoli sprouts overcame my genetics and saved my life from cancer, heart disease and Alzheimer's.
broccoli sprouts have antiviral, antibacterial, antifungal properties that fight the infections that cross the blood brain barrier.
Required actions (3)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps that you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
The claims on your website establish that the products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction, into interstate commerce for such uses violates the Act.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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