WARNING LETTER
Sovereign Laboratories, LLC
MARCS-CMS 566227 —
February 05, 2019
Product:
Dietary Supplements
Recipient:
Recipient Name
Douglas Wyatt
Recipient Title
President
Sovereign Laboratories, LLC
2020 Contractors Road, Suite 5
Sedona
,
AZ
86336-4528
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
WARNING LETTER
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
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”:
“The proline-rich polypeptides (PRPs) in colostrum enhance the body’s defense against oxidative stress, reducing the inflammatory processes that precede Alzheimer’s disease. Studies have shown PRPs improve the cognitive functioning of patients with mild to moderate Alzheimer’s disease, suggesting that bovine colostrum may have a role in preventing the progression of Alzheimer’s.”
On the webpage titled, “Colostrum-LD: Truly A Miracle Food”:
“Colostrum has proven effectiveness against numerous deadly viruses, including HIV, flu, and rotavirus, and it has been shown to be more than three times as effective as flu vaccine.”
“Help fight off and eliminate infectious processes.”
“Peptides have been identified in milk and colostrum which function as ACE-inhibitors to lower blood pressure significantly.”
“Viralox
®
(Nature’s first broad spectrum anti-viral and other pathogenic support)”
On the webpage titled, “Colostrum-derived Peptides™ in Bovine Colostrum May Help in Fight Against Alzheimer’s Disease”:
“Recent research suggests that many ‘young’ people in their 40s are exhibiting early symptoms of Alzheimer’s disease. This should be a wake-up call for everyone. Research also suggests that the proline-rich polypeptides in bovine colostrum (CDPs) may help in the fight against Alzheimer’s disease and other brain diseases that involve cognitive decline.”
“[Colostrum-derived Peptides] CDPs also may help reduce or prevent the symptoms of Alzheimer’s disease, along with the symptoms of Huntington’s disease, sporadic ALS, epilepsy, post-stroke neurodegration
[sic]
, and other neurodegenerative disorders.”
“…[I]t’s very likely that bovine colostrum supplementation may play a crucial role in reducing the risk of cognitive decline, dementia, and Alzheimer’s disease in middle-age people or may delay the debilitating effects for those who are in the earliest stages of cognitive decline. Stay tuned as this is an area of significant interest, especially because at present, there are no truly effective pharmacological treatments for 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”:
“Anti-cancer defense”
“Anti-obesity defense”
“Cholesterol reduction”
“Anti-hypertensive effect”
“Anti-microbial activity”
“Anti-vral
[sic]
activity”
“Delayed onset of Alzheimer’s symptoms”
On the webpage titled, “The Benefits of Colostrum Supplementation”:
“A number of serious health syndromes are now known to be associated with abnormally increased gut permeability. 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. Research shows that colostrum can correct this leaky gut syndrome with its unique combination of immune factors and growth stimulators, which includes epithelial growth factors.”
On the webpage titled, “What Practitioners Say About Colostrum”:
“Another ‘incurable’ disease, Multiple Sclerosis, seems to be positively affected by colostrum. One client was prescribed conventional pharmaceutical medications by a doctor. She refused to take them and tried colostrum instead. When she paid a return visit to her doctor, he was amazed at the improvement in her condition.”
On the promotional literature titled, “It’s a Gut Decision” which accompanies the sale of your product, Colostrum-LD
®
:
On pp 7-8:
“[Leaky Gut Syndrome] LGS allows toxins…to enter our bloodstream unchecked. …This leads to chronic immune system disruption, chronic inflammatory response (pain) and malfunction, or autoimmune disease of all forms including Alzheimer’s, ALS, Parkinson’s and other mental health conditions such as ADHD and depression. …Colostrum’s growth factors heal the G.I. lining and prevent Leaky Gut Syndrome.”
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”
“Acts as a Natural Antibiotic – helps destroy harmful pathogens and fight infection…”
“Imagine it. No pain. No chronic illness. No allergies…All this and more may be possible with bovine colostrum.”
On p. 36, under the heading, “Growth Hormones in Colostrum”:
“Help detect and destroy diseased, infected and cancerous cells”
“Regulate . . . cholesterol levels”
On p. 38, under the heading, “Natural Vaccines that Offer Virus Protection”:
“Colostrum naturally contains anti-bodies for the following viruses which helps your body build immunity (in a similar way to how vaccines work):”
“Adenovirus”
“Alphavirus”
“Dengue virus”
“Echovirus”
“Epstein-Barr virus”
“Enterovirus 71”
“Hantavirus”
“Hepatitis C virus”
“HIV-1”
“Human Papilloma virus”
“Influenza”
“Japanese Encephalitis”
“Measles”
“Polio Virus”
“Respiratory Syncytial Virus”
“Rotavirus”
“St. 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. Three weeks after I placed her on PRO Colostrum-LD, the pain and swelling in her joints had all but disappeared, and she no longer required braces on her lower legs.”
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:
“. . . [T]hirty-six year old Debi of Kentucky . . . found relief not only for her asthma and allergies but also for the disturbing and unsightly skin eruptions and broken veins…”
On p. 50, under the heading, “How to Make the Most of Colostrum”:
“ …[C]olostrum can help enhance health and healing from chronic diseases, including arthritis, osteoporosis, diabetes, heart disease, cancer, depression, Alzheimer’s disease, and other types of dementia.”
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”:
“Colostrum-LD begins to work immediately, killing off pathogenic microbes . . ..It stimulates the production of antibodies . . . to prevent and eliminate infections.”
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
®
”:
“Anyone with a chronic disease, autoimmune condition, or allergies should be taking Colostrum-LD.”
Under the subheading, “Colostrum-LD
®
Liposomal Delivery makes the Difference”:
“Helps eliminate harmful pathogens and fight infection.”
“Helps stimulate wound healing”
Under the subheading, “Colostrum-LD
®
Suggested Standard of Use”:
“For HEALING LEAKY GUT SYNDROME and CHRONIC/AUTOIMMUNE CONDITIONS”
Under the subheading, “Colostrum-LD
®
Companion Products”:
“Viralox
®
Health Spray is recommended for individuals dealing with infections…”
Viralox has been clinically shown to be effective against a wide range of viruses including Herpes, Influenza, Human Papilloma, Rotavirus, Polio, Adenovirus, Hepatitis C, Hanta, Respiratory Syncytial, Alpha viruses such as Semliki Forest and Sindbis, and Enteroviruses such as Enterovirus-71, EpsteinBar [
sic
], and Cytomegalovirus. Viralox™ is effective against a broad range of other pathogens including bacteria, yeast, and fungi.”
“Curcumin-LD
®
Liposomal Delivers Curcuminoids: … researchers consider curcumin a potential therapeutic agent for the prevention and/or treatment of various conditions, including arthritis, allergies, Alzheimer’s disease, diabetes, cardiovascular, neurogenerative, and other inflammatory illnesses.”
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:
Viralox® contains concentrated PRP-2s and lactoferrin which has been clinically proven to eliminate infections, especially viral infections… Viralox® has been clinically shown to be effective against a wide range of viruses including Herpes, Influenza, Human Papilloma, Rotavirus, Polio, Adenovirus, Hepatitis C, HIV, Hanta, Respiratory Syncytial, Alpha viruses…Enteroviruses…Epstein Bar, and Cytomegalovirus.”
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
.
Sincerely,
/S/
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
cc:
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
Content current as of:
02/11/2019
Regulated Product(s)
Dietary Supplements