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Merchient’s ingredient library

What can you say about folate in your ads and on your site?

The library supports 7 wordings for folate; the strongest is “Helps form red blood cells” (strong, 30-1,000 µg folic acid a day). Avoid wording that names or implies a disease, a drug or a treatment, such as “Prevents birth defects, or reduces the risk of neural tube defects or spina bifida”.

Also called: Folic acid, Vitamin B9, Folacin, Methylfolate, L-methylfolate, 5-MTHF, L-5-MTHF, 5-Methyltetrahydrofolate, L-5-Methyltetrahydrofolate

Reviewed

Not legal advice. This guide shows the wording that published evidence supports at a daily dose, from the sources linked below; it is not a ruling on any claim. Your own product, its form and dose, and your own evidence still need to match the wording you use.

Supported wordings

What you can say.

Strong evidenceWording 1

Claims Facts

“Helps form red blood cells.”

Daily dose30-1,000 µg folic acid a day
SupportListed by Health Canada and authorized in the EU (normal blood formation) after EFSA review.
Dose detailsHealth Canada: 30-1,000 µg a day for adults 19 and older (30-800 µg at 14 to 18), counted as micrograms of folic acid, not dietary folate equivalents (DFE). EU: at least 30 µg, 15% of the 200 µg EU reference value (Regulation (EU) No 1169/2011, Annex XIII). 1,000 µg a day is the ODS upper limit for folic acid from supplements and fortified foods.
FormFolic acid or L-5-methyltetrahydrofolate (or its calcium or glucosamine salt)
SourcesHealth Canada monograph: Multi-Vitamin/Mineral Supplements
Commission Regulation (EU) No 432/2012, list of permitted health claims

Moderate evidenceWording 2

Claims Facts

“Supports normal immune function.”

Daily dose30-1,000 µg folic acid a day
SupportAuthorized in the EU after EFSA review; Health Canada does not list it.
Dose detailsEU: at least 30 µg, 15% of the 200 µg EU reference value (Regulation (EU) No 1169/2011, Annex XIII). 1,000 µg a day is the ODS upper limit for folic acid from supplements and fortified foods.
FormFolic acid or L-5-methyltetrahydrofolate (or its calcium or glucosamine salt)
SourceCommission Regulation (EU) No 432/2012, list of permitted health claims

Moderate evidenceWording 3

Claims Facts

“Helps reduce tiredness and fatigue.”

Daily dose30-1,000 µg folic acid a day
SupportAuthorized in the EU after EFSA review; Health Canada does not list it.
Dose detailsEU: at least 30 µg, 15% of the 200 µg EU reference value (Regulation (EU) No 1169/2011, Annex XIII). 1,000 µg a day is the ODS upper limit for folic acid from supplements and fortified foods.
FormFolic acid or L-5-methyltetrahydrofolate (or its calcium or glucosamine salt)
SourceCommission Regulation (EU) No 432/2012, list of permitted health claims

Moderate evidenceWording 4

Claims Facts

“Has a role in the normal process of cell division.”

Daily dose30-1,000 µg folic acid a day
SupportAuthorized in the EU after EFSA review; Health Canada does not list it.
Dose detailsEU: at least 30 µg, 15% of the 200 µg EU reference value (Regulation (EU) No 1169/2011, Annex XIII). 1,000 µg a day is the ODS upper limit for folic acid from supplements and fortified foods.
FormFolic acid or L-5-methyltetrahydrofolate (or its calcium or glucosamine salt)
SourceCommission Regulation (EU) No 432/2012, list of permitted health claims

Moderate evidenceWording 5

Claims Facts

“Supports normal homocysteine metabolism.”

Daily dose30-1,000 µg folic acid a day
SupportAuthorized in the EU after EFSA review; Health Canada does not list it.
Dose detailsEU: at least 30 µg, 15% of the 200 µg EU reference value (Regulation (EU) No 1169/2011, Annex XIII). 1,000 µg a day is the ODS upper limit for folic acid from supplements and fortified foods.
FormFolic acid or L-5-methyltetrahydrofolate (or its calcium or glucosamine salt)
SourceCommission Regulation (EU) No 432/2012, list of permitted health claims

Moderate evidenceWording 6

Claims Facts

“Supports normal psychological function.”

Daily dose30-1,000 µg folic acid a day
SupportAuthorized in the EU after EFSA review; Health Canada does not list it.
Dose detailsEU: at least 30 µg, 15% of the 200 µg EU reference value (Regulation (EU) No 1169/2011, Annex XIII). 1,000 µg a day is the ODS upper limit for folic acid from supplements and fortified foods.
FormFolic acid or L-5-methyltetrahydrofolate (or its calcium or glucosamine salt)
SourceCommission Regulation (EU) No 432/2012, list of permitted health claims

Moderate evidenceWording 7

Claims Facts

“Supports normal maternal tissue growth during pregnancy.”

Daily dose30-1,000 µg folic acid a day
SupportAuthorized in the EU after EFSA review; Health Canada does not list this wording.
Dose detailsEU: at least 30 µg, 15% of the 200 µg EU reference value (Regulation (EU) No 1169/2011, Annex XIII). 1,000 µg a day is the ODS upper limit for folic acid from supplements and fortified foods. Health Canada says a prenatal supplement must give at least 400 µg of folate a day.
FormFolic acid or L-5-methyltetrahydrofolate (or its calcium or glucosamine salt)
SourceCommission Regulation (EU) No 432/2012, list of permitted health claims

How strong the evidence is

Strong evidence
At least two listed sources support it independently at a comparable dose and form, and none disagrees.
Moderate evidence
One listed source supports it as an evidence-based use at that dose, and no listed source disagrees.
Limited evidence
The only support is traditional use, the sources disagree, or the source itself calls the evidence weak.

Wordings to avoid

What to leave out.

Claims Facts

Ingredient: Folate

Wording to avoidReason
“Prevents birth defects, or reduces the risk of neural tube defects or spina bifida”Names birth defects. In the US this is FDA’s authorized health claim (21 CFR 101.79), with set wording and conditions (see fda_health_claims); Health Canada’s version is a Canada only note.Disease
“Supports healthy brain and spinal cord development in the baby”FDA’s folate health claim names ‘birth defects of the brain or spinal cord’ (21 CFR 101.79(c)(2)(i)(C)), so this wording reads as that claim without its required conditions.Disease
“Treats anemia, or folate-deficiency anemia”Names a disease.Disease
“Lowers homocysteine to protect the heart, or reduces the risk of heart disease or stroke”Names diseases. FDA’s qualified claim on folic acid, vitamin B6 and vitamin B12 and vascular disease has set wording (see fda_health_claims).Disease
“Treats depression”Names a mental health disorder; the supported EU wording is normal psychological function.Disease

Disease: names or implies a disease. Drug: names a drug or presents the product as one. Treatment: promises to treat, cure or prevent a condition.

Sources

Where this comes from.

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