California Prop 65 for Supplement Brands: What You Need to Know
Recorded sources last checked between August 19, 2026 and October 2, 2026. 25 of 25 recorded claims have no open issue recorded. Source check due February 18, 2027. The page also includes 1 Inventory Ready estimate as of September 23, 2026; estimates are not counted as sourced claims.
By Greg Huang, founder since 2009 in the dietary supplement and nutrition industry
Reviewed by Dr. James Pendleton, ND, licensed primary care physician, 20+ years in naturopathic medicine
Proposition 65 (officially the Safe Drinking Water and Toxic Enforcement Act of 1986) is California's chemical warning law. It requires businesses to warn consumers about significant exposures to chemicals that cause cancer, birth defects, or reproductive harm.
For a supplement brand, the practical questions are specific: Does an exemption apply? What exposure does the product cause? What evidence supports the warning decision? Use this guide to prepare those questions, read test results correctly, and coordinate any required warning across your label and online listings.
The short answer
Dietary supplement manufacturers must comply with 21 CFR Part 111 (Current Good Manufacturing Practice for dietary supplements). This includes requirements for personnel, facilities, equipment, production, laboratory operations, and record-keeping.
What Prop 65 Is
The Office of Environmental Health Hazard Assessment (OEHHA) maintains the list of chemicals covered by Prop 65. Check the current list against your ingredients and product. The presence of a listed chemical does not, by itself, answer whether a warning is required.
The law covers certain discharges into drinking water sources and warnings for exposures to listed chemicals, subject to exemptions. This guide focuses on the consumer-product warning question. Businesses with fewer than 10 employees are exempt; a small business may still have obligations under its sales agreements.
Exposure at or below an applicable safe-harbor level needs no warning. An exposure above that level does not automatically establish a violation: an independent risk assessment may support an exemption under the regulations. See OEHHA's business FAQ (checked September 18, 2026) for warning and exemption guidance.
Why Prop 65 Matters Outside California
Company location and consumer location are different questions. Use the checks below if your products reach California consumers.
- E-commerce reaches California. Check where your direct store, distributors, and marketplaces sell the product. Do not treat an out-of-state business address as an exemption.
- Contracts allocate work. Read the applicable retailer and distributor agreements. Confirm who supplies warning content, applies it to products, and maintains online displays.
- Private enforcement exists. The statute permits public-interest enforcement actions when its conditions are met. Keep the evidence supporting your decision; do not wait for a dispute to reconstruct it.
- Selling channels need coordination. If a warning is needed, check each California sales channel. A label change does not automatically update an online listing.
Four Metals to Check in a Lab Report
A heavy metals panel can help assess lead, cadmium, arsenic, and mercury. These four do not exhaust the Prop 65 list. Ask which listed chemicals and chemical forms are relevant to your formula, ingredients, and process.
| Chemical | What to Check | Prop 65 Concern |
|---|---|---|
| Lead | Compare daily exposure, not concentration alone. Lead has separate reproductive and oral cancer values. | Cancer and reproductive harm. MADL: 0.5 mcg/day (reproductive). NSRL: 15 mcg/day oral (cancer). |
| Cadmium | Match the exposure route. The inhalation NSRL is not an oral cancer threshold. | Cancer and reproductive harm. MADL: 4.1 mcg/day oral (reproductive). NSRL: 0.05 mcg/day inhalation (cancer). |
| Arsenic (inorganic) | Check whether the report measures total arsenic or inorganic arsenic. They are different measurements. | Cancer. NSRL: 10 mcg/day except inhalation; 0.06 mcg/day inhalation. |
| Mercury | Confirm the relevant chemical form and exposure assessment. Do not invent a safe-harbor number when none is adopted. | Developmental harm for mercury and mercury compounds. Methylmercury compounds also have a cancer listing. No adopted NSRL or MADL. |
NSRL and MADL are daily exposure thresholds. NSRL (No Significant Risk Level) applies to carcinogens. MADL (Maximum Allowable Dose Level) applies to reproductive toxicants. Some chemicals, like lead and cadmium, have both an NSRL and a MADL. Check both applicable endpoints and match the route of exposure. Do not compare an oral exposure with an inhalation limit. Check the OEHHA safe-harbor table for current values (checked September 18, 2026).
Not every listed chemical has a safe-harbor number, and the absence of one is not an exemption. Mercury is the example on this page. Without an adopted level, there is no published safe-harbor number to compare against. A qualified professional can assess whether the anticipated exposure supports an exemption. See OEHHA's guidance for businesses. Do not treat “no listed limit” as a passing result.
Testing and Compliance Options
Start with the exposure assessment, then decide whether a warning is required. The options below are not an exhaustive list of legal exemptions. OEHHA does not require a specific test or a blanket every-batch testing schedule under its warning regulations.
Establish the Exposure and Decision Basis
Agree on the relevant chemicals, sample plan, methods, and reporting limits with a qualified laboratory or specialist. Testing can support the assessment, but a concentration result alone is not a warning decision. Record the applicable safe harbor or other assessment basis.
- Price example: Medallion Labs lists $164 per analysis for its four-metal package (checked September 18, 2026). This is one laboratory's price, not a full compliance budget.
- Scope check: That package measures total arsenic, not a separate inorganic arsenic result. Ask whether speciation, lower reporting limits, or a different method is needed for your product.
- Budget: Get a product-specific quote covering sample count, test scope, interpretation, and any repeat testing. Confirm the lab accepts your product matrix.
Provide a Warning When Required
When the assessment calls for a warning, choose the applicable wording and delivery method. OEHHA discourages warnings for exposures that do not warrant them. Do not add a warning simply because the evidence has not been assessed.
- Work to quote: Warning review, artwork, printing, and online listing updates
- Owner: Name who approves the warning and who applies it in each sales channel
- Check: Review the physical product and the online buying path before relying on the warning
For guidance on what testing to expect from your manufacturer, see our supplement testing requirements guide. For understanding test results, see our guide to reading a COA.
Warning Label Requirements
OEHHA's safe-harbor regulations provide warning formats and methods deemed clear and reasonable. These formats are optional: a business using an alternative may need to defend it if challenged. Food warnings, including dietary supplements, have specific content under 27 CCR 25607.2. Use the provisions for the relevant exposure.
What the Full-Length Food Warning Includes
- WARNING, CA WARNING, or CALIFORNIA WARNING in bold uppercase
- Food-specific wording about consuming the product; no warning symbol is required for this format
- The relevant listed chemical names and cancer or reproductive-harm wording for the exposure
- The food warning URL: www.P65Warnings.ca.gov/food
- The applicable food-warning presentation and delivery requirements in 27 CCR 25607.1
Where the Warning Must Appear
Follow the applicable food-warning delivery methods in 27 CCR 25607.1. For internet sales, the safe-harbor rules also require an online warning before purchase is completed. The warning can appear on the product display page, through a clearly marked warning link on that page, or through another prominent display before checkout is completed. Purchasers must not have to search the general website content for it. The online warning does not replace the warning delivered on or with the product. See OEHHA's business FAQ.
Common Prop 65 Mistakes
- Assuming it doesn't apply because you're not in California. Check California exposure and applicable exemptions. Where the company is based does not resolve the warning question.
- Using an outdated warning format. The short-form transition depends on when a product was manufactured and labeled. Under 27 CCR 25603(c), products manufactured and labeled before January 1, 2028, may use the prior short-form content regardless of their sale date. Check the applicable food-warning format rather than assuming every older product must be relabeled by the end of 2027.
- Treating a concentration as daily exposure. A result in mcg/g or ppm cannot be compared directly with a limit in mcg/day. Product amount and use matter. Ingredient inclusion rates also matter when working from raw-material data.
- Treating one panel as a complete assessment. Confirm the chemicals, chemical forms, reporting limits, product matrix, and sample plan. Ask what formula, ingredient-source, or process changes would require reassessment.
- Ignoring e-commerce warning requirements. For internet purchases using the safe harbor, a physical warning alone is insufficient. Section 25602(b) also provides online methods: the warning on the product display page, a clearly marked warning link on that page, or another prominent warning before purchase is completed. Do not hide it in general website content.
- Waiting for a lawsuit to take action. Keep the decision basis, lab reports, approved warnings, and channel records together. If you receive a notice, preserve those records and contact qualified counsel promptly.
Getting Started with Prop 65 Compliance
Our recommended preparation checklist helps you give a laboratory or regulatory specialist the information needed for a useful answer.
- Document California sales channels, business size, sales-agreement terms, formula, serving directions, and any existing warning decision.
- Identify the relevant listed chemicals and chemical forms. Agree on the evidence or tests needed; do not assume a four-metal panel covers everything.
- Check units, reporting limits, sample identity, and daily-use assumptions. Ask the specialist to explain the exposure calculation and its regulatory basis.
- Record the applicable exemption, safe harbor, independent risk assessment, or warning decision. Above a safe harbor is a reason for assessment, not an automatic verdict.
- If a warning is needed, approve the applicable food-warning format and check the product, retailer handoff, and online display before purchase.
- Assign an owner for the records and reassessment triggers, such as a changed formula, ingredient source, serving direction, or applicable regulation.
Worked units example: an Inventory Ready illustration, not a lab result. A hypothetical finished powder result of 0.10 mcg/g multiplied by 5 g/day equals 0.50 mcg/day. This shows the unit conversion, not a compliance verdict. A reporting limit, chemical form, exposure assumption, or applicable exemption can change the assessment.
For a broader view of compliance risks, see our supplement compliance risks guide. For label requirements beyond Prop 65, see our packaging and label compliance guide.
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Greg Huang, founder since 2009 in the dietary supplement and nutrition industry
Founder of Inventory Ready. Previously founded and operated multiple consumer brands in the dietary supplement and nutrition industry since summer 2009.
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Disclaimer: This guide is educational content, not legal or regulatory advice. Prop 65 compliance involves legal obligations. Consult a qualified attorney experienced in Prop 65 litigation before finalizing your compliance approach. OEHHA thresholds and the Prop 65 chemical list are updated regularly. See our Terms of Service for details.
Primary sources
The sourced claims in this guide are grounded in the following primary references. The guide's source manifest maps each claim to its source and verification date.
- California Health & Safety Code § 25249.5 et seq. (Chapter 6.6, added November 4, 1986 by initiative Proposition 65)
- 27 CCR 25705 (NSRL table): 'Cadmium .
- OEHHA NSRL/MADL safe-harbor table (no mercury or methylmercury entry), cross-checked against 27 CCR 25805 and the OEHHA chemical pages for mercury and for methylmercury
- Title 27, CCR, Article 6
- 27 CCR 25607.1 and 25607.2
- California Health & Safety Code § 25249.7(d)
- Title 27, CCR, § 25602(b)
- Health & Safety Code 25249.11(b), verbatim: "'Person in the course of doing business' does not include any person employing fewer than 10 employees in his or her business"
- Medallion Labs Heavy Metals Package, published price; checked September 18, 2026
- OEHHA, 'Proposition 65 Clear and Reasonable Warnings Questions and Answers for Businesses' (revised July 2018), Q3/A3: 'The warning regulations do not require a business to perform any testing.'
- OEHHA, Frequently Asked Questions for Businesses ('What requirements does Proposition 65 place on companies doing business in California?'); Cal. Health & Safety Code 25249.6
- 27 CCR 25102(o)
- 27 CCR 27001(a), citing Cal. Health & Safety Code 25249.8
- 27 CCR 25705, history note 52