Warning letter · FDA Warning Letters

ICA Health, LLC/Future Formulations, LLC: FDA Warning Letter 614383 (Sep 20, 2021)

Agency action: Sep 20, 2021Record ID: fda_warning_-e2bd685235b52c39
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What happened

Original notice title

ICA Health, LLC/Future Formulations, LLC MARCS-CMS 614383, September 20, 2021

From the archived source record

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 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 . . . . Chronic illness and toxic treatments like chemotherapy are major stressors that the adrenals must respond to. . . . 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). 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)].

What the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

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Status and source details

Status recorded in the archive
FDA closeout listed
Source checked
Jul 16, 2026
Record revision
1c41f7dfe5f6

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.

Sources, dates, and coverage →

What is affected

Product
About ICA Health; About Dr. James L. Wilson, DC, ND, PhD; Why Dr. Wilson Created Supplements for Adrenal Fatigue
Company
ICA Health, LLC/Future Formulations, LLC
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.