Below are twelve phrases and claim patterns that appear repeatedly in FDA warning letters issued to dietary supplement companies. These are high-risk because they either explicitly reference disease or strongly imply treatment of a disease condition. The table also includes safer structure/function alternatives that companies commonly use to stay within DSHEA and 21 CFR 101.93.
These examples are useful when screening labels, websites, Amazon listings, and social media marketing before approving production. This is not a comprehensive list of compliant and non-compliant language. It is only to be used as examples.
What is a “Disease”
Under FDA regulations (21 CFR 101.93(g)), a disease is defined as:
Damage to an organ, part, structure, or system of the body such that it does not function properly, or a state of health leading to such dysfunction.
Diseases typically require medical diagnosis or treatment.
Examples of Diseases
• Diabetes
• Hypertension (high blood pressure)
• Cancer
• Arthritis
• Depression
• Alzheimer’s disease
• Heart disease
• Osteoporosis
Examples of Non-Disease Conditions Often Used in Structure/Function Claims
• Occasional sleeplessness
• Temporary fatigue
• Mild stress
• Occasional digestive discomfort
• General wellness support
NOTE: It is important to note that regulatory compliance is not secured by using a few “magic words” or by avoiding some triggering terms. The overall message implied by the label and marketing language will be used by regulators to determine compliance.
Common High-Risk Supplement Claims and Compliant Alternatives
High-Risk Phrase / Claim Pattern | Why FDA Flags It | Safer Structure/Function Alternative |
Lowers blood sugar | Implies diabetes treatment | Supports healthy glucose metabolism |
Regulates blood sugar levels | Diabetes implication | Helps maintain healthy glucose levels already within the normal range |
Lowers blood pressure | Hypertension treatment | Supports healthy blood pressure already within the normal range |
Reduces inflammation | Disease-related inflammatory conditions | Supports a healthy inflammatory response |
Detoxifies heavy metals | Drug-like detoxification claim | Supports the body’s natural detoxification processes |
Treats anxiety | Mental health disease claim | Supports a calm and relaxed mood |
Anti-depressant | Drug classification | Supports emotional well-being |
Arthritis relief | Treatment of arthritis | Supports joint comfort and mobility |
Burns fat / melts fat | Weight loss drug implication | Supports healthy weight management when combined with diet and exercise |
Prevents heart disease | Disease prevention claim | Supports cardiovascular health |
Anti-cancer / anti-tumor | Cancer treatment claim | Supports normal cellular health |
Natural alternative to statins / insulin / antidepressants | Drug comparison claim | Supports healthy cholesterol metabolism or cardiovascular health |
Why These Trigger FDA Enforcement
Most warning letters cite one or more of the following regulatory provisions:
FD&C Act Section 201(g)
Defines products intended to treat disease as drugs.
21 CFR 101.93(g)
Defines disease claims vs structure/function claims.
If a supplement is marketed with disease claims, it becomes:
An unapproved new drug
Misbranded under the FD&C Act
Phrases That Are Often Safe (When Used Correctly)
These terms generally fall within structure/function claim territory when properly qualified.
Examples regulators usually accept:
• Supports immune health
• Promotes healthy digestion
• Supports cognitive function
• Helps maintain healthy cholesterol levels already within the normal range
• Supports joint mobility
• Supports a healthy inflammatory response
• Promotes restful sleep
• Supports cardiovascular health
These must include the DSHEA disclaimer when used on labeling.
The “Biomarker Trap” (A Frequent Compliance Mistake)
Many marketers believe they are compliant when referencing biomarkers like:
blood sugar
cholesterol
blood pressure
cortisol
However, FDA frequently interprets these as disease claims if phrased improperly.
Example:
Claim | FDA Interpretation |
Controls blood sugar | Diabetes claim |
Supports healthy blood sugar already within the normal range | Usually acceptable |
The phrase “already within the normal range” is often used to avoid implying disease treatment.
Highest-Risk Marketing Areas for Supplements
Claims involving the following topics receive the highest enforcement attention:
Diabetes / blood sugar
Weight loss
Mental health
Cancer
Cardiovascular disease
Hormones (testosterone, estrogen)
Detox / heavy metals
Brands entering these categories should perform extra regulatory review before marketing.
Practical Guidance for Clients
Before submitting labels or marketing materials, clients should verify that claims:
• Do not reference diseases
• Do not imply drug-like treatment
• Do not compare supplements to prescription drugs
• Are supported by scientific evidence
When structure/function claims are used, labels must include the DSHEA disclaimer:
“These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”