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CRITICALNutrition / Supplements

ICA Health, LLC/Future Formulations, LLC

FDA issued a warning letter to ICA Health, LLC/Future Formulations, LLC (Dr. James L. Wilson) after reviewing three websites in July 2021 and finding that five dietary supplement products — Dr. Wilson's Good Sugar, Super Immune Space Sprinkles, Cortisol Stress Reset, BFF, and Nat-Stim — were marketed with disease-treatment claims that rendered them unapproved new drugs under the FD&C Act. The claims linked the products to conditions including diabetes, metabolic syndrome, cardiovascular disease, autoimmune disorders, herpes, fibromyalgia, and cancer-related adrenal fatigue, among others. Four of the five products were also found to be misbranded because adequate directions for layperson use could not be written for prescription-level intended uses. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Adrenal support can greatly enhance the treatment protocol for alcoholism and many other types of addiction.

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.

Full adrenal support can be a crucial aid to health for people with RA.

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.

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.

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.

Dr. Wilson's BFF is designed to promote immune efficacy in preserving the outbreak-free (dormancy) phase of chronic infection

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.

Diabetics and people with metabolic syndrome may find that Good Sugar . . . helps them feel their best.

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.

Hypoglycemic properties of: [ingredients in Dr. Wilson's Good Sugar] cinnamon, gymnema, Indian Kino, fenugreek, jambolan, gulvel, chromium, magnesium, zinc, vanadium

Adequate adrenal support . . . can be important factors in minimizing stressrelated herpes outbreaks.

Each of our supplements is formulated by James L. Wilson, DC, ND, PhD to target specific health issues related to stress, including adrenal fatigue.

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.

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.

L-Lysine has also [been] shown to prevent high blood pressure

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.

Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

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