A qualified health claim is one of the few tools FDA gives food and supplement companies to link an ingredient to a reduced disease risk on a label. For EPA and DHA omega-3s, FDA authorizes two sets of qualified health claim language covering coronary heart disease and hypertension – but the enforcement discretion letters that permit them come with specific content thresholds, mandatory disclaimers, and category exclusions that trip up compliance teams regularly. This guide walks through the exact authorized wording, the gram thresholds that actually apply (and the one that does not), how EPA/DHA qualified health claims relate to structure/function and nutrient content claims, and the process for requesting a new one.
What Is a Qualified Health Claim, and How Is It Different From an Authorized Health Claim?
FDA recognizes three distinct claim categories on food and dietary supplement labels, and mixing them up is the fastest way to trigger a warning letter.
- Authorized health claims meet the “significant scientific agreement” (SSA) standard under 21 CFR 101.14 and part 101, subpart E. FDA reviews the full body of evidence and, when the science clears that bar, permits an unqualified statement of the disease-risk relationship.
- Qualified health claims (QHCs) apply when the evidence is real but does not meet the SSA standard. FDA calls this the “credible evidence” standard. Because the science is weaker, the claim itself must carry qualifying language – hedge words like “supportive but not conclusive” – so the label does not overstate what the evidence shows.
- Structure/function claims describe how a nutrient affects the body’s normal structure or function (for example, “supports heart health”) without asserting a reduced disease risk. These claims do not require FDA pre-clearance, but 21 CFR 101.93 requires a specific disclaimer and the claim cannot cross the line into disease-claim territory.
FDA does not “approve” qualified health claim petitions in the way it approves a drug application. Instead, a company submits a petition, FDA reviews the evidence, and if the evidence clears the credible-evidence bar, FDA issues a Letter of Enforcement Discretion. That letter specifies the exact claim language a product may use and the conditions attached to it – it does not involve formal rulemaking, and FDA can withdraw or revise its discretion if new evidence changes the picture.
The Two Authorized EPA and DHA Claim Statements
FDA has issued enforcement discretion for EPA and DHA qualified health claims in two rounds. Both remain valid today, and each has its own exact required wording – substituting your own phrasing is not an option.
2004 claim (still valid):
“Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease (CHD).”
2019 claims (four permitted variants, covering blood pressure and CHD via hypertension):
- “Consuming EPA and DHA combined may help lower blood pressure in the general population and reduce the risk of hypertension. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.”
- “Consuming EPA and DHA combined may reduce blood pressure and reduce the risk of hypertension, a risk factor for CHD. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.”
- “Consuming EPA and DHA combined may reduce the risk of CHD by lowering blood pressure [or by reducing the risk of hypertension]. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.”
- “Research shows that consuming EPA and DHA combined may be beneficial for moderating blood pressure, a risk factor for CHD. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.”
Dietary supplements do not need to restate the EPA/DHA amount in the claim itself if that amount is already declared in the Supplement Facts panel under 21 CFR 101.36.
Claim Requirements at a Glance: The Three Gram Thresholds Compliance Teams Confuse
Most of the confusion around this claim traces back to three different gram figures that apply in three different contexts. Only two of them apply to the EPA/DHA qualified health claim at all.
| Threshold | Amount | What It Actually Governs |
|---|---|---|
| Minimum content to bear the QHC | 0.8 g/day combined EPA and DHA | The lowest intake level FDA found credible evidence for in the blood-pressure studies it reviewed (Steiner et al. 1989; Meyer et al. 2009). A product must meet or exceed this to use the claim at all. |
| Maximum intake before bleeding-risk concerns | 5 g/day combined EPA and DHA | The safety ceiling FDA set based on clinical trial data on bleeding risk. Products cannot bear the QHC above this level. |
| GRAS limit for conventional foods (unrelated to this QHC) | 3.0 g/day (3 g/p/d) | A 1997 GRAS determination for menhaden oil in conventional foods, codified at 21 CFR 184.1472. This limit governs how much EPA/DHA a manufacturer may add to a conventional food under that GRAS status – it does not set the content threshold for the qualified health claim itself. |
If your compliance team is searching for a “3 grams per day” rule for this claim, it is worth confirming which question is actually being asked: how much EPA and DHA the product must contain to use the QHC (0.8 g/day minimum, 5 g/day maximum), or how much may be added to a conventional food under the separate menhaden oil GRAS notification (3.0 g/day). Conflating the two is a common – and avoidable – labeling error. FDA’s broader approach to nutrient additions in conventional foods is covered in our clarification of FDA’s fortification policy.
Additional Enforcement Discretion Factors FDA Applies
Beyond the content thresholds above, FDA’s letter lists several other conditions a product must meet before the EPA/DHA QHC is available:
- Saturated fat limits differ by product type. Conventional foods must meet the “low saturated fat” criteria in 21 CFR 101.14(a)(4); dietary supplements instead must meet the “1 g or less of saturated fat per RACC” criterion in 21 CFR 101.62(c)(2), without the “no more than 15 percent of calories from saturated fat” test.
- Cholesterol limits apply to most dietary supplements. Non-liquid dietary supplements must meet the “low cholesterol” criterion of 20 mg or less per RACC under 21 CFR 101.62(d)(2).
- Disqualifying nutrient levels still apply. Products cannot exceed the disqualifying levels for total fat, saturated fat, cholesterol, or sodium in 21 CFR 101.14(a)(4).
- The 10 percent Daily Value rule applies to conventional foods only. A conventional food must contain at least 10 percent of the Daily Value for vitamin A, vitamin C, iron, calcium, protein, or fiber before any nutrient fortification, per 21 CFR 101.14(e)(6). Dietary supplements are exempt from this particular requirement.
Dietary supplement labels carry their own separate set of enforcement pressure points beyond health claims. Our guides on grandfathered dietary ingredients and caffeine in dietary supplements cover two other areas where FDA has taken a similarly close look at supplement label claims.
Qualified Health Claims vs. Structure/Function Claims for Omega-3 Products
Companies marketing EPA/DHA products often have a choice between a qualified health claim and a structure/function claim, and the two carry very different compliance burdens. A structure/function claim – “supports cardiovascular health,” for example – does not require FDA pre-clearance and can be used more flexibly, but it cannot reference a disease or a reduced disease risk, and it requires the DSHEA disclaimer that the statement has not been evaluated by FDA. A qualified health claim can reference a specific disease risk (CHD, hypertension) specifically because FDA has already reviewed the evidence and issued enforcement discretion for that specific language – but only that language, and only under the conditions above.
For companies deciding between the two approaches, or evaluating whether an existing structure/function claim on an omega-3 product has drifted into disease-claim territory, our FDA compliance attorneys can review label language before it goes to print.
Nutrient Content Claims for Omega-3s: A Related but Separate Category
A third label category applies specifically to statements like “high in omega-3” or “good source of DHA.” These are nutrient content claims, governed by a different set of regulations than the qualified health claim discussed above, and FDA has taken enforcement action against omega-3 nutrient content claims that did not meet the applicable criteria. Our detailed breakdown of FDA’s restrictions on omega-3 nutrient content claims covers what qualifies and what does not. For a broader look at how authorized, qualified, and nutrient content claims interact across a full label, see our guide to FDA’s expansion of authorized health claims.
Why Infant Formula and Foods for Children Under Two Cannot Use This Claim
Companies fortifying infant formula with DHA sometimes ask whether the EPA/DHA qualified health claim can appear on that product. It cannot. Under 21 CFR 101.14(e)(5), a food’s label cannot represent or purport that the product is for infants or toddlers under two years of age and still carry a health claim, unless that specific claim is expressly authorized for that use elsewhere in subpart E. Neither the 2004 nor the 2019 EPA/DHA enforcement discretion letter carries that authorization. Manufacturers marketing DHA-fortified infant formula should rely on other permitted label statements for that category rather than the QHC language above.
How to Petition FDA for a New Qualified Health Claim
If your company has scientific evidence supporting a disease-risk relationship that is not yet covered by an existing qualified health claim, FDA’s petition process is the path to enforcement discretion for new claim language:
- Compile the scientific evidence. FDA weighs the full body of publicly available evidence, not just studies favorable to the claim, so the petition should account for all of it, not a favorable subset.
- Submit a health claim petition. Petitions are filed with FDA and become part of the public docket on Regulations.gov – the EPA/DHA petition that led to the 2019 letter, for example, lives in docket FDA-2014-Q-1146 – where FDA and the public can review and comment on the submission.
- Respond to FDA’s evidence-based review. FDA evaluates whether the evidence meets the credible-evidence standard for a qualified claim, and may request additional information before issuing a decision.
- Receive FDA’s determination. If FDA finds credible evidence, it issues a Letter of Enforcement Discretion specifying the exact claim language, content thresholds, and other conditions – similar in structure to the EPA/DHA letters discussed above. If the evidence does not clear that bar, FDA issues a letter of denial.
Given how narrowly FDA drafts the permitted language and the conditions attached to it, companies considering a new petition benefit from legal review before submission, not after a denial. For a broader view of the compliance risks around food labeling claims generally, see our guide to food labeling laws, requirements, and risks.
Frequently Asked Questions
What is the difference between an authorized health claim and a qualified health claim?
An authorized health claim meets FDA’s “significant scientific agreement” standard and can be stated without qualifying language. A qualified health claim applies when the evidence is real but does not meet that higher bar, so FDA requires hedge language such as “supportive but not conclusive” to accurately represent the strength of the science.
Can dietary supplements use the EPA and DHA qualified health claim?
Yes. Both conventional foods and dietary supplements can use the claim, but the eligibility criteria differ – for example, dietary supplements are exempt from the 10 percent Daily Value requirement that applies to conventional foods, and follow a different saturated fat threshold.
What is the difference between a qualified health claim and a structure/function claim?
A qualified health claim references a specific disease risk and requires FDA enforcement discretion for that exact language. A structure/function claim describes an effect on the body’s normal structure or function, does not require FDA pre-clearance, but cannot reference a disease or disease risk.
How much EPA and DHA must a product contain to use this claim?
At least 0.8 g/day combined EPA and DHA, based on the lowest intake level FDA found credible evidence for. Products cannot exceed 5 g/day combined EPA and DHA under the claim’s safety ceiling. The often-cited “3 grams per day” figure is a separate GRAS limit for conventional foods under 21 CFR 184.1472 and does not set the threshold for this claim.
Can infant formula use the EPA and DHA qualified health claim?
No. Under 21 CFR 101.14(e)(5), foods represented for infants or toddlers under two years of age cannot bear a health claim unless that specific claim is expressly authorized for that use, and the EPA/DHA letters do not carry that authorization.
How does a company petition FDA for a new qualified health claim?
A company submits a health claim petition with its scientific evidence, which becomes part of the public docket on Regulations.gov. FDA reviews the evidence under its credible-evidence standard and issues either a Letter of Enforcement Discretion specifying permitted claim language or a letter of denial.
This article is for informational purposes only and does not constitute legal advice. Consult a qualified attorney about your specific situation.
This guide was prepared by OFW Law’s Mike Goodman, who counsels food and dietary supplement clients on FDA and FTC health claims enforcement.
Reviewing whether your EPA and DHA label language meets FDA’s current enforcement discretion conditions, or considering a petition for a new qualified health claim? Connect with the OFW Law team about your FDA labeling compliance.
