What happened
Original notice title
Sovereign Laboratories, LLC MARCS-CMS 566227, February 05, 2019
From the archived source record
These include all auto-immune diseases including Crohn’s disease, diabetes, autism, lupus, multiple sclerosis, Alzheimer’s, Parkinson’s, arthritis, cholera, Salmonella and E. coli infection, HIV, arthritis, chronic fatigue syndrome, hepatitis, cystic fibrosis, alcoholism, muscular dystrophy, fibromyalgia, and scleroderma, asthma, and allergies. One client was prescribed conventional pharmaceutical medications by a doctor. Louis Virus” “West Nile Virus” “Yellow Fever Virus” On p. 42, under the heading, “Clinical Studies Supporting Colostrum’s Benefits”: “An eleven year-old patient with severe juvenile rheumatoid arthritis did not improve with conventional pharmaceutical treatments. A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, Colostrum-LD ® , Viralox ® ,and Curcumin-LD ® fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)]. The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction. Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- e033d348dc30
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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