Preterm birth (PTB) is a significant health risk globally, occurring before week 37 and early preterm birth before week 34. Nutritional support during pregnancy can decrease neonatal complications and death. Long-chain omega-3 polyunsaturated fatty acids (LC-PUFAs), including DHA Supplementation and EPA, have been proposed to extend gestational duration. However, no specific guidance is provided by major governmental agencies. The latest update from the Office of Dietary Supplements (ODS) helps fill this gap with clearer scientific direction.
Office of Dietary Supplements Issues New Guidance on DHA Supplementation for Prevention of Preterm and Early Preterm Birth
Preterm birth (PTB) is a significant health risk globally, occurring before week 37 and early preterm birth before week 34. Nutritional support during pregnancy can decrease neonatal complications and death. Long-chain omega-3 polyunsaturated fatty acids (LC-PUFAs), including DHA Supplementation and EPA, have been proposed to extend gestational duration. However, no specific guidance is provided by major governmental agencies. The latest update from the Office of Dietary Supplements (ODS) helps fill this gap with clearer scientific direction.
Office of Dietary Supplements (ODS):
The Office of Dietary Supplements (ODS) operates as a part of the NIH Office of the Director based in Bethesda Maryland to support dietary supplement development research since its establishment in 1994. The Office of Dietary Supplements serves as the national authority for dietary supplement research by leading NIH-funded studies and other agency research to enhance public health outcomes. The organization employs experts who lead international recognition in their fields of chemistry and nutrition and epidemiology to handle sophisticated problems in dietary supplement science and policy development.
ODS recommendation about Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA): [1]
ODS has issued a key update acknowledging DHA’s role in reducing preterm and early preterm birth — the first official acknowledgment of its significance based on scientific evidence supporting DHA recommendations for maternal and fetal health.
Section | Details / Recommendations |
Publishing Organization | Office of Dietary Supplements (ODS), National Institutes of Health (NIH) |
Key Update | ODS released new guidance acknowledging DHA’s role in reducing preterm and early preterm birth — the first official endorsement of DHA for this purpose. |
Scientific Basis | Clinical research shows DHA and EPA (long-chain omega-3 fatty acids) lower the risk of preterm birth. |
General Recommendations (All Pregnant Women) | |
Daily Intake | At least 250 mg/day of DHA + EPA |
Pregnancy-Specific Supplementation | Additional 100–200 mg/day DHA during pregnancy |
High-Risk Individuals (Risk of Preterm Birth) | |
Daily Intake | 600–1000 mg/day DHA and/or EPA |
Start Date | Begin in the second trimester, no later than 20 weeks gestation |
Duration | Continue until childbirth or approximately 37 weeks gestation |
These dosage insights contribute to evolving DHA pregnancy guidelines and more evidence-based prenatal supplementation strategies.
Scientific basis of DHA and EPA recommendation by ODS:
Features of ODS Research on Maternal Omega-3
ODS research shows that while omega-3 supplementation does not consistently enhance cognitive or visual development in infants, strong evidence demonstrates its effectiveness in reducing the risk of maternal nutrition and preterm birth complications.
However, there was strong evidence that omega-3 intake (especially DHA) was associated with a reduced risk of preterm and early preterm birth.
Statement and Supporting Evidence from ISSFAL 2022
- The International Society for the Study of Fatty Acids and Lipids (ISSFAL) published a 2022 statement that included two large trials published after the 2018 Cochrane review.
- These trials further reinforced the evidence of the protective effect of DHA on the risk of premature birth.
- Specifically, ISSFAL reported taking omega-3 supplements resulting in,
- 12% risk reduction in all preterm births.
- 35% risk reduction in early preterm births.
Regulatory Guidelines for DHA Claims: U.S., EU, Canada, and India
Global regulatory frameworks differ significantly, making it critical for nutraceutical manufacturers and supplement brands to comply with jurisdiction-specific regulations while relying on robust science.
Region | Regulator(s) | Does the Regulator Set mg Requirements? | Allowed Claims | Restricted / Not Allowed Claims | Key Labelling Rules |
United States[2] | FDA, FTC | No fixed mg requirement for DHA/EPA in supplements | •Structure/function claims (“supports brain health”) • Nutrient-content claims (“contains DHA”) ODS guidance suggests 250 mg/day DHA+EPA and 100–200 mg DHA extra for pregnancy — scientific advice, not regulation | Disease-risk reduction claims (e.g., “reduces preterm birth risk”) unless FDA-approved | • Must include FDA disclaimer • Claims must be truthful & substantiated |
European Union[3] | EFSA | Yes, if using EFSA-approved claims | • Only EFSA-authorized claims • Requires: — 250 mg EPA+DHA/day for heart claim — 200 mg DHA/day for maternal brain/eye claim | Any unapproved claim, including preterm birth risk reduction | • Must use EFSA-approved wording • Must meet nutrient thresholds to use claims |
Canada[4] | Health Canada (approval), CFIA (enforcement) | No mandatory mg requirement (mg must match evidence) | • Evidence-backed, pre-approved health claims | Any health claim without scientific substantiation and approval | • Must meet Health Canada claim rules • CFIA enforces accuracy and compliance |
India[5] | FSSAI | Yes, for infant formula & certain nutrition categories | • Claims allowed when nutrient composition meets FSSAI standards (e.g., DHA % rules) | Disease-risk or misleading claims | • DHA levels must meet FSSAI content standards • Advertising must be truthful |
International Regulatory Alignment: ODS Recommendations on DHA and Preterm Birth
While the updated guidance from the Office of Dietary Supplements on DHA intake during pregnancy recognizes the strong evidence supporting DHA’s role, it does not authorize preterm birth reduction claims on consumer labels. Instead, it provides a unified scientific baseline for companies involved in nutraceutical product development, custom supplement formulation, and advanced dietary supplement development.
Key Considerations
- Recommendation versus regulation: Even though an ODS recommendation provides a scientific viewpoint/clarity, the label still needs to have approvals from the jurisdictional body to make claims like “reduces risk of preterm birth.”
- Different rules for each market: While the science converges, each regulatory system (FDA/FTC, EFSA, Health Canada/CFIA, FSSAI) has its own definitions, claims categories, and approval processes.
- Opportunity for harmonization: ODS recommendations represent a starting point for potential standardization in regards to evidence requirements, definitions of dosage, and messaging consistency across global markets.
Implications for Industry
- Labelling: If the agency has not approved the associated claims, do not make explicit claims of risk reduction. Use compliant and neutral wording, such as:
“Provides DHA to improve maternal and foetal health.”
- Regulatory Submissions: Include information it the evidence file that references the ODS recommendations plus the evidence, dosages, and safety information from clinical studies.
- Marketing/Communications: It is acceptable to reference the ODS recommendations in professional materials; however, it is important to not imply that the ODS has sanctioned the recommendations in consumer-facing materials.
- Safety Information: Include dosing information, and “consult your health care provider”, especially when the recommendation is for pregnant or nursing women.
Product Examples:
- Product Name: Fairhaven prenatal DHA+ EPA
- Used for: Pregnant mother during second trimester
- Form: soft gels
- Recommended range: 1000mg/day for pregnant mothers
Conclusion:
ODS’s updated guidance reinforces the crucial role of DHA in reducing preterm and early preterm birth. However, authorization to make such claims remains dependent on regional regulatory frameworks. Food Research Lab supports global brands by combining science, regulation, and innovation—offering services in nutraceutical product development, custom supplement formulation, dietary supplement development, regulatory consulting, clinical validation, safety testing, and manufacturing.
FRL is committed to delivering high-quality maternal nutrition solutions backed by scientific evidence supporting DHA recommendations for maternal and fetal health. Connect with FRL at Food Research Lab to develop products aligned with the latest updated guidance from the Office of Dietary Supplements on DHA intake during pregnancy.
Reference:
- DSM-Firmenich. (2025, June 16). New NIH fact sheet highlights critical role of omega-3 pregnancy supplements in reducing preterm birth. Retrieved from https://www.dsm-firmenich.com/en/businesses/health-nutrition-care/news/talking-nutrition/new-nih-fact-sheet-highlights-critical-role-of-omega-3-pregnancy-supplements-in-reducing-preterm-birth.html
- Food Safety and Standards Authority of India. (2022, October 4). Compendium: Food for Infant Nutrition Regulations 2020 (Version I). Retrieved from https://www.fssai.gov.in/upload/uploadfiles/files/Compendium_Food_Infant_04_10_2022.pdf
- European Food Safety Authority. (2011). Scientific opinion on the substantiation of health claims related to DHA, EPA and brain, eye and nerve development (ID 501, 513, 540) and maintenance of normal brain function, vision, maternal health; pregnancy and nursing (ID 514) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal, 9(4), 2078. https://doi.org/10.2903/j.efsa.2011.2078
- Canadian Food Inspection Agency. (n.d.). Health claims on food labels. Government of Canada. Retrieved from https://inspection.canada.ca/en/food-labels/labelling/industry/health-claims
- Food Safety and Standards Authority of India. (2022, October 4). Compendium: Food for Infant Nutrition Regulations 2020 (Version I). Retrieved from https://www.fssai.gov.in/upload/uploadfiles/files/Compendium_Food_Infant_04_10_2022.pdf
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