WARNING LETTER
ICA Health, LLC/Future Formulations, LLC
MARCS-CMS 614383 —
September 20, 2021
Delivery Method:
VIA UPS
Product:
Drugs
Recipient:
Recipient Name
Dr. James L. Wilson
Recipient Title
Owner/Manager
ICA Health, LLC/Future Formulations, LLC
1340 E. 20th Street
Tucson
,
AZ
85719-6710
United States
Issuing Office:
Office of Human and Animal Foods Operations – Division West 4
United States
September 20, 2021
WARNING LETTER
Ref: CMS #614383
Dear Dr. Wilson:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at www.icahealth.com, www.drwilsons.com, and www.adrenalfatigue.org in July 2021 and has determined that you take orders there for Dr. Wilson’s Good Sugar, Dr. Wilson’s Super Immune Space Sprinkles, Dr. Wilson’s Cortisol Stress Reset, Dr. Wilson’s BFF, and Dr. Wilson’s Nat-Stim. The claims on your websites, www.icahealth.com, www.drwilsons.com, and www.adrenalfatigue.org establish 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 can find the Act and FDA regulations through links on FDA’s home page at
www.fda.gov.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
Dr. Wilson’s Good Sugar product pages on www.icahealth.com, www.drwilsons.com, and www.adre nalfatigue.org:
“Refined carbohydrate consumption spikes your blood sugar up and the vicious cycle of blood sugar imbalance and insulin resistance continues…”
“Can people with diabetes or metabolic syndrome take Dr. Wilson’s Good Sugar? . . . Diabetics and people with metabolic syndrome may find that Good Sugar . . . helps them feel their best.”
Additionally, your www.icahealth.com website includes the following on the Dr. Wilson’s Good Sugar product page:
“Hypoglycemic properties of: [ingredients in Dr. Wilson’s Good Sugar] cinnamon, gymnema, Indian Kino, fenugreek, jambolan, gulvel, chromium, magnesium, zinc, vanadium”
Dr. Wilson’s Super Immune Space Sprinkles product pages on www.icahealth.com, www.drwilsons.com, and www.adrenalfatigue.org:
“[Ingredients of Dr. Wilson’s Super Immune Space Sprinkles are] selected to support immune function in young intestinal tracts . . . Chronic or frequent stress can cause an increased tendency towards inflammation and decreased effectiveness of the deeper, adaptive aspects of immunity that defend against disease. This can leave your child more susceptible to colds, flu and other infections, as well as to the development of allergies.”
Dr. Wilson’s Cortisol Stress Reset product pages on www.icahealth.com, www.drwilsons.com, and www.adrenalfatigue.org:
“Cortisol calming support for stressed-out people . . . The same cortisol-regulated changes designed to help you deal with an acute stressor become harmful when stress is frequent or chronic over extended periods of time. Chronically elevated:
o Blood sugar produces increased insulin, insulin resistance and increased abdominal fat, which can potentially develop into metabolic syndrome and diabetes
o Blood pressure and heart rate contribute to cardiovascular disease
o Excitatory brain stimulation can lead to anxiety and mood disorders, cognitive and memory impairment, sleep problems …
o Stress hormones suppress immune function and makes cells less responsive to the anti-inflammatory actions of cortisol, increasing inflammation.”
Dr. Wilson’s BFF product pages on www.icahealth.com, www.drwilsons.com, and www.adrenalfatigue.org:
“[Dr. Wilson’s BFF] Supports general and specific aspects of immune function . . . . Stress & Immune Efficacy . . . With chronic stress, this cortisol-related decrease in immune efficacy can leave you more prone to recurrent outbreaks; more susceptible to colds, flu and other infections; and potentially more vulnerable to serious illness and degenerative disease down the road, as well as to the development of allergies and autoimmune disorders.”
“When stress is chronic or prolonged, both the increase in inflammation and the decrease in overall immune function can begin to adversely affect your health.”
Additionally, your www.adrenalfatigue.org website for the Dr. Wilson’s BFF product page includes:
“What does Dr. Wilson’s BFF do? Dr. Wilson’s BFF is designed to promote immune efficacy in preserving the outbreak-free (dormancy) phase of chronic infection”
Dr. Wilson’s Nat-Stim product pages on www.icahealth.com, www.drwilsons.com, and www.adrenalfatigue.org:
“[Ingredient(s) in Dr. Wilson’s Nat-Stim are] essential for immune function . . . . Stress and Immune Function . . . With chronic stress, this cortisol-related decrease in immune function can leave you more susceptible to colds, flu and other infections, and potentially make you more vulnerable to serious illness and degenerative disease down the road, as well as to the development of allergies and autoimmune disorders.”
“When stress is chronic or prolonged, both the increase in inflammation and the decrease in overall immune function can begin to adversely affect your health.”
In addition to claims on specific product pages, your websites also provide evidence that your products are intended for use as drugs because you describe the products as treating stress or adrenal fatigue and on separate pages describe specific diseases as being linked to stress or adrenal fatigue, thereby implying that your products are intended to cure, mitigate, treat, or prevent disease. Examples of this additional evidence of intended use include:
Webpage titled “About ICA Health” on www.icahealth.com:
“Each of our supplements is formulated by James L. Wilson, DC, ND, PhD to target specific health issues related to stress, including adrenal fatigue.”
The home page of www.drwilsons.com:
“Got Stress? We’ve Got the Solution! Dr. Wilson’s Original Formulations brand is a line of dietary supplements for stress formulated by Dr. James L. Wilson.”
Webpage titled “About Dr. James L. Wilson, DC, ND, PhD” on www.adrenalfatigue.org:
“Read an article by Dr. Wilson describing why he formulated the Doctor Wilson’s Original Formulations® supplements for stress and adrenal fatigue”
Webpage titled “Why Dr. Wilson Created Supplements for Adrenal Fatigue” by Dr. James L. Wilson on www.adrenalfatigue.org:
“I continue to pursue this mission through . . . developing equally unique and effective formulas targeted to areas of health adversely affected by stress, such as blood sugar balance and immune function.”
Webpage Article titled “How Stress Affects the Body” on www.adrenalfatigue.org:
“How Stress Affects the Body”
o “depression…”
o “higher cholesterol, high blood pressure, increased risk of heart attack and stroke”
o “increased inflammation … pains…”
o “decreased immune function … increased risk of becoming ill…”
Webpage Article titled “Stress and Health” on www.adrenalfatigue.org:
“Stress and Immune Function . . . . With chronic stress, this cortisol-related decrease in immune function can leave you more susceptible to colds, flu and other infections, and potentially make you more vulnerable to serious illness and degenerative disease … as well as to the development of allergies and autoimmune disorders.”
“Stress and Thyroid Function . . . . When adrenal function is low, thyroid medication may be ineffective until adequate adrenal function (and cortisol) is restored. . . . This stress induced reduction in T3 and increase in reverse T3 in your cells results in tissue hypothyroidism that is not detected in standard thyroid function lab tests but can potentially produce . . . depression”
“Stress is also one of the environmental factors that increase vulnerability to thyroid autoimmunity (e.g. Hashimoto’s thyroiditis).”
Webpage Article titled “What Is Adrenal Fatigue?” on www.adrenalfatigue.org:
“What is Adrenal Fatigue? . . . Most commonly associated with intense or prolonged stress, it can also arise during or after acute or chronic infections, especially respiratory infections such as influenza, bronchitis or pneumonia.”
Webpage Article titled “Adrenal Function” on www.adrenalfatigue.org:
“Adrenal Function in Blood Sugar Balance and Sugar Metabolism . . . . [C]hronic or repeated stress can contribute to persistent insulin resistance, and the resulting high levels of glucose (hyperglycemia) and insulin circulating in the blood that are likely precursors to metabolic syndrome and type 2 diabetes.”
“[A]drenal fatigue with concomitant hypoglycemia may create conditions and induce behaviors that can lead to a greater tendency to develop adult onset diabetes.”
“[S]ome level of adrenal fatigue often accompanies hypoglycemia, diabetes and metabolic syndrome.”
Webpage Article titled “Cortisol & Adrenal Function” on www.adrenalfatigue.org:
“Chronically lower levels of circulating cortisol (as in adrenal fatigue) have been associated with negative effects, such as: … mild depression … low thyroid function … hypoglycemia … low blood pressure … Lowered immune function … Inflammation”
Webpage Article titled “FAQ on Adrenal Fatigue” on www.adrenalfatigue.org:
“Is adrenal fatigue common in someone with cancer who is going through chemotherapy? The extreme fatigue that accompanies cancer and any other chronic illnesses is often the result of decreased adrenal function. Chronic illness and toxic treatments like chemotherapy are major stressors that the adrenals must respond to. . . . It is very important to provide adrenal support during this time.”
This webpage, as well as from a tab on the main website, link to an article titled “Adrenal Fatigue in Health Related Conditions” on www.adrenalfatigue.org:
“Processes that take place in any chronic disease, from arthritis to cancer, place demands on your adrenal glands. Therefore, it is likely that if you are suffering from a chronic disease . . . your adrenals may have become fatigued to some degree.”
“Alcoholism and Addiction”
o “A common, but often ignored, component of alcoholism and some other addictions is fatigued adrenal glands. Adrenal fatigue and its associated hypoglycemia (low blood sugar) may often precede substance abuse”
o “Adrenal support can greatly enhance the treatment protocol for alcoholism and many other types of addiction.”
“Autoimmune Disease”
o “During adrenal fatigue, it is less likely that your adrenal glands can produce enough cortisol to adequately counter these autoimmune inflammatory reactions.”
“Immunity”
o “[C]hronic, recurring or severe illness – particularly bronchitis, pneumonia or other respiratory infections – can contribute to fatiguing the adrenals”
“Dental Health”
o “Unresolved dental problems are common, but often unrecognized, sources of stress and adrenal fatigue. These include tooth abscesses . . . decayed teeth, root canals with sub-acute infections, gingivitis and other gum infections”
“Fibromyalgia”
o “The cause of fibromyalgia is unknown, but there seems to [be] general agreement that stress is a significant precipitating factor in its development. It has been commonly referred to as a “stress-related disorder” because stress both precedes its onset and aggravates it symptoms. . . . people with fibromyalgia are likely to also be experiencing some degree of adrenal fatigue.”
o “Providing adequate support for healthy adrenal function during stress can be an important contributing factor in maintaining the vitality to avoid the stress-induced precipitation of fibromyalgia, and in facilitating full recovery from fibromyalgia.”
“Herpes”
o “Research has shown that herpes outbreaks increase in frequency with stresses . . . especially when adrenal function is low (as it is during adrenal fatigue).”
o “[P]eople experiencing adrenal fatigue are likely to suffer more herpes outbreaks.”
o “[A]s a chronic infection, herpes is a continuing body burden that can contribute to adrenal fatigue.”
o “Adequate adrenal support . . . can be important factors in minimizing stressrelated herpes outbreaks.”
“Hypoglycemia”
o “Both stress and adrenal fatigue can contribute to hypoglycemia (low blood sugar) . . . . It has been known for almost a century that people who are chronically hypoglycemic are often also experiencing adrenal fatigue”
“Mild Depression”
o “[P]eople going through adrenal fatigue . . . have been observed clinically to often also experience mild depression.”
“Rheumatoid Arthritis”
o “RA [rheumatoid arthritis] … may contribute to adrenal fatigue.”
o “[A]rthritic pain may seem more intense during adrenal fatigue.”
o “Full adrenal support can be a crucial aid to health for people with RA.”
Webpage Article titled “The Uses and Wonders of L-Lysine” on www.adrenalfatigue.org:
“Whether you’re suffering from high blood pressure, stress-induced anxiety … L-Lysine [an ingredient in Dr. Wilson’s BFF] may just be exactly was you’re looking for.”
“Some researchers believe this [L-Lysine’s] ability to save off outbreaks also helps in the prevention of many other diseases related to cranial nerves such as migraines, Meniere’s disease, and Bell’s palsy.”
“L-Lysine has also [been] shown to prevent high blood pressure”
Webpage Article titled “Stress and the Common Cold” on www.adrenalfatigue.org:
“Ways to support your immune system while under stress . . . Zinc [an ingredient in Dr. Wilson’s Immune Space Sprinkles, Dr. Wilson’s Nat-Stim, and Dr. Wilson’s Good Sugar] is crucial in both innate (non-specific) and adaptive (antigen specific) immune function and is important in antibody formation. Deficiencies [in Zinc] . . . can severely weaken immune function.”
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)]. With certain exceptions not applicable here, 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 CFR 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 Dr. Wilson’s Good Sugar, Dr. Wilson’s Cortisol Stress Reset, Dr. Wilson’s BFF, and Dr. Wilson’s Nat-Stim products 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, Dr. Wilson’s Good Sugar, Dr. Wilson’s Cortisol Stress Reset, Dr. Wilson’s BFF, and Dr. Wilson’s Nat-Stim 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)].
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps 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. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Kathy Tormey, Compliance Officer; 6th Ave and Kipling St, DFC Bldg. 20, PO Box 25087, Denver, Colorado, 80225-0087. You may reach Ms. Tormey at Kathleen.tormey@fda.hhs.gov or (303) 236-3137 if you have any questions about this matter.
Sincerely,
/S/
E.Mark Harris
Denver District Director & Program Division Director
Office of Human and Animal Foods Operations –
Division West 4
Content current as of:
10/05/2021
Regulated Product(s)
Drugs