February 5, 2019
Sovereign Laboratories, LLC
Attn: Douglas Wyatt, President
2020 Contractors Road, Suite 5
Sedona, AZ 86336-4528
Dear Mr. Wyatt:        
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at the internet addresses www.sovereignlaboratories.com and www.soverignhealthinitiative.org in October 2018 and has determined that you take orders there for your products Colostrum-LD®, Viralox®,and Curcumin-LD®. The claims on your websites establish that these products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (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. You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Examples of some of the claims observed on your website that provide evidence your products are intended for use as drugs include the following:
On your website, www.soveriegnlaboratories.com:
On the webpage titled, “The Top 5 Anti-Aging Properties of Colostrum”:
On the webpage titled, “Colostrum-LD: Truly A Miracle Food”:
On the webpage titled, “Colostrum-derived Peptides™ in Bovine Colostrum May Help in Fight Against Alzheimer’s Disease”:
On your website sovereignhealthinitiative.org, which includes a link to www.sovereignlabortories.com where your products are sold:
On the webpage titled, “Anti-Aging Benefits of Bovine Colostrum”:
On the webpage titled, “The Benefits of Colostrum Supplementation”:
On the webpage titled, “What Practitioners Say About Colostrum”:
On the promotional literature titled, “It’s a Gut Decision” which accompanies the sale of your product, Colostrum-LD®:
On pp 7-8:
On p. 23, under the heading, “Bovine colostrum contains more than 100 biologically active components that perform all sorts of healing actions in the body”
On p. 36, under the heading, “Growth Hormones in Colostrum”:
On p. 38, under the heading, “Natural Vaccines that Offer Virus Protection”:
On p. 42, under the heading, “Clinical Studies Supporting Colostrum’s Benefits”:
On p. 45, under the heading, “What Consumers Say,” the publication contains evidence of intended use in the form of a personal testimonial recommending or describing the use of Colostrum-LD for the cure, mitigation, treatment, or prevention of disease:
On p. 50, under the heading, “How to Make the Most of Colostrum”:
On the promotional literature titled, “Before You Take Colostrum-LD® - Read This First” which accompanies the sale of your product, Colostrum-LD®:
Under the subheading, “How long until I feel results”:
On the promotional literature titled, “Radiant Health…Made Possible with Colostrum-LD®” which accompanies the sale of your product, Colostrum-LD®:
Under the subheading, “Why Sovereign Laboratories Colostrum-LD®”:
Under the subheading, “Colostrum-LD® Liposomal Delivery makes the Difference”:
Under the subheading, “Colostrum-LD® Suggested Standard of Use”:
Under the subheading, “Colostrum-LD® Companion Products”:
Finally, claims made on your Facebook page, www.facebook.com/DouglasWyatt.CNR, which links to your website at www.sovereignlaboratories.com where your products can be purchased directly, provide further evidence that your products are intended for use as drugs. For example:
In a September 25, 2014 post for Viralox® Health Spray:
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
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). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 C.F.R. § 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your products Colostrum-LD®, Viralox®,and Curcumin-LD® are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. 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. It is your responsibility to ensure that all products marketed by your firm comply with all requirements of federal law, including FDA regulations.
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.
We also note that your product Viralox®, which is marketed as a dietary supplement, bears directions for use as an oral spray product. However, the Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i) [21 U.S.C. § 321(ff)(2)(A)(i)] as a product that is “intended for ingestion.” Because oral spray products are intended to enter the body directly through the mucosal tissues at the back of the throat, they are not dietary supplements and are not foods.
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. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your written reply should be directed to Shawn Goldman, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions, please contact Mr. Goldman at Shawn.Goldman@fda.hhs.gov.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety and Applied Nutrition 
Sovereign Laboratories, LLC
PO Box 763
Sedona, AZ 86339-0763
Domains By Proxy, LLC
14747 N. Northsight Blvd
Suite 111, PMB 309
Scottsdale, AZ 85260

This page was posted on March 13, 2019.

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