What is it used for?
All products
Source of (an) antioxidant(s)/Provides (an) antioxidant(s) (for the maintenance of good health) [Source note 2].
Source of (an) antioxidant(s)/Provides (an) antioxidant(s) for the maintenance of eye health [Source note 3].
Source of (an) antioxidant(s)/Provides (an) antioxidant(s) that help(s) fight/protect (cell) against/reduce (the oxidative effect of/the oxidative damage caused by/cell damage caused by) free radicals [Source note 4].
Products containing Lutein, Lutein esters and/or Marigold extract (not supported by zeaxanthin or zeaxanthin esters - products must provide lutein/lutein esters at therapeutic dose to support these uses)
Helps to maintain eyesight/support eye health in conditions (associated with sunlight damage), such as cataracts and age-related macular degeneration [Source note 5].
Helps to reduce the risk of developing cataracts [Source note 6].
Helps to improve macular pigment optical density [Source note 7].
Since lutein and zeaxanthin or their esters are both antioxidants and usually present together in a product formulation, there is an option to use the source of antioxidants claims in plural. The singular should be used when the product only contains synthetic zeaxanthin without lutein.
The above uses can be combined on the product label (e.g., Helps to improve macular pigment optical density and reduce the risk of developing cataracts).
What this guide covers
A product may include one or more of the active ingredients listed in Table 1.
Who does this guide cover?
Adults 18 years and older
How is it taken?
Oral
Which forms are covered?
this reference excludes foods or food-like dosage forms as indicated in the Compendium of references Guidance Document.
Quantities
LUTEIN AND ZEAXANTHIN
Antioxidant
Lutein Not to exceed 20 milligrams of lutein, per day [Source note 8].
and/or
Zeaxanthin Not to exceed 2.5 milligrams of zeaxanthin, per day [Source note 9].
Other uses¹
Lutein 6 - 20 milligrams of lutein, per day [Source note 10].
¹Notes
The quantity of the lutein must be indicated on the product documentation form and label and meet the therapeutic dose.
Disclosing the amount of zeaxanthin in a product is optional. Zeaxanthin (Optional) 0.7 - 2.5 milligrams of zeaxanthin, per day [Source note 11].
LUTEIN AND ZEAXANTHIN ESTERS
Antioxidant
Lutein esters Not to exceed 40 milligrams of lutein esters, per day [Source note 12].
and/or
Zeaxanthin esters Not to exceed 5 milligrams of zeaxanthin esters, per day (FAO/WHO 2025; USP-NF 2024; Christen et al. 2008; Fletcher et al. 2008; Johnson et al. 2008; Moeller et al. 2008).
Other uses¹
Lutein esters 12 - 40 milligrams of lutein esters, per day [Source note 13].
¹Notes
The quantity of the lutein esters must be indicated on the product documentation form and label meet the therapeutic dose.
Disclosing the amount of zeaxanthin esters in a product is optional. Zeaxanthin esters (Optional) 1.5 - 5 milligrams of zeaxanthin esters, per day (FAO/WHO 2025; USP-NF 2024; Christen et al. 2008; Fletcher et al. 2008; Johnson et al. 2008; Moeller et al. 2008).
MARIGOLD EXTRACT¹
Methods of preparation: Standardized extracts
Antioxidant
Extract containing 60% or less lutein esters and providing 40 milligrams or less of lutein esters, per day [Source note 14].
Optional potency Not to exceed 5 milligrams of zeaxanthin esters, per day (FAO/WHO 2025; USP-NF 2024; Christen et al. 2008; Fletcher et al. 2008; Johnson et al. 2008; Moeller et al. 2008).
Other uses
Extract containing 60% or less lutein esters and providing 12-40 milligrams of lutein esters, per day [Source note 15].
Optional potency 1.5 - 5 milligrams of zeaxanthin esters, per day (FAO/WHO 2025; USP-NF 2024; Christen et al. 2008; Fletcher et al. 2008; Johnson et al. 2008; Moeller et al. 2008).
¹Notes
The quantity of the marigold extract must be indicated on the product documentation form and label.
The quantity of the potency constituent, lutein esters, must meet the therapeutic dose for uses other than antioxidants.
Lutein and zeaxanthin esters are potencies of marigold extract and must be indicated as such on the product documentation form and label. The amounts of the esters must be expressed as the quantity (mg) and/or percent (%) of the total quantity of the marigold extract.
Disclosing the amount of zeaxanthin esters in a product is optional.
How is it used?
Products containing Lutein esters, Zeaxanthin esters and/or Marigold extract
Take with a meal containing oil/fat [Source note 16].
How long is it used?
The reference does not require an additional label statement in this section. This does not establish an absence of risk.
Warnings and precautions
The reference does not require an additional label statement in this section. This does not establish an absence of risk.
When should it be avoided?
The reference does not require an additional label statement in this section. This does not establish an absence of risk.
Possible side effects
The reference does not require an additional label statement in this section. This does not establish an absence of risk.
Storage
Must be established in accordance with the requirements described in the applicable product regulations.
All products (information for industry; not for labelling)
Store in tightly sealed, light- and oxygen-resistant container in a cool, dry place [Source note 17].
Conditions for combined preparations
When lutein esters and/or zeaxanthin esters are combined with marigold extract, the maximum daily amount specified for lutein esters and/or zeaxanthin esters must not be exceeded. The total daily intake of lutein esters and/or zeaxanthin esters from all sources in the product, including marigold extract, must be taken into account.
When combined, half the amounts of Lutein esters or Zeaxanthin esters should be taken into consideration to calculate the total amount of Lutein or Zeaxanthin (e.g. 10 mg of lutein and 5 mg of lutein esters from Marigold extract would be equivalent to 10 mg + 2.5 mg = 12.5 mg of total lutein).
Preparation details
Ingredient identity, preparation requirements, and other details that define the scope of this guide.
Ingredients and preparations
| Proper name(s) | Common name(s) | Source information / Source ingredient(s) | Source information / Source material(s) | Source information / Part(s) | Source information / Preparation(s) |
|---|---|---|---|---|---|
| (3R,3'R,6'R)-beta,epsilon-Carotene-3,3'-diol | Lutein | N/A | Tagetes erecta | Herb flowering oleoresin | Non-synthetic |
| Zeaxanthin | N/A | Tagetes erecta | Herb flowering oleoresin | Non-synthetic |
| Zeaxanthin | Zeaxanthin | N/A | N/A | Synthetic |
| Lutein esters | Lutein esters | N/A | Tagetes erecta | Herb flowering oleoresin | Non-synthetic |
| Zeaxanthin esters | Zeaxanthin esters | N/A | Tagetes erecta | Herb flowering oleoresin | Non-synthetic |
| Tagetes erecta |
| N/A | Tagetes erecta | Flower | Dry |
References: Proper names: FAO/WHO 2025; USDA 2025; NIH 2024; USP-NF 2024; Common names: FAO/WHO 2025; NIH 2024; USP-NF 2024; Source information: FAO/WHO 2025; USP-NF 2024.
Other ingredients
Must be chosen from the current source ingredient database and must meet the limitations outlined in the database.
Preparation and quality requirements
The finished product specifications must be established in accordance with the requirements describes in the source authority source’s product quality guidance.
The active ingredient(s) must comply with the requirements outlined in the source ingredient database.
Some commercial lutein preparations are sold as "5% or 10% lutein". These preparations are actually purified lutein (esterified or free) typically added at 5-15% to an inert stabilizing medium (e.g. USP-NF 2024: Lutein Preparation). When using these preparations, the applicant must specify whether lutein is esterified or free and use the appropriate dose information. For these preparations, the stabilizing medium must be listed as a non- active ingredient in the product documentation form and label and identified with the purpose "stabilizing agent" in the product documentation form.
In all cases where lutein and zeaxanthin (free or esterified) are listed on the product documentation form, potency testing at the finished product stage is required to verify the quantity as different preparations may provide different amounts of lutein and zeaxanthin OR the manufacturer of the finished product should ensure that there are sufficient controls on the raw materials so that the quantity of lutein and zeaxanthin (esterified or free) is the actual amount of lutein and zeaxanthin and not the amount of the lutein and zeaxanthin with the stabilizing agent.
LUTEIN AND ZEAXANTHIN
The active ingredient must comply with the specifications outlined in either of the following references: FAO/WHO 2025: Lutein from Tagetes erecta or USP-NF 2024: Lutein, Lutein Preparation
Lutein and zeaxanthin are preparations from the oleoresin of marigold (Tagetes erecta) petals obtained by hexane extraction and purified by saponification and crystallization.
LUTEIN AND ZEAXANTHIN ESTERS
Lutein and zeaxanthin esters are preparations of oleoresin of marigold (Tagetes erecta) petals obtained by hexane extraction and then purified and concentrated.
MARIGOLD EXTRACT
Marigold extract is a hexane extraction of the African marigold (Tagetes erecta) flowers which provides less than 60% lutein.
Guide change history
Updates to this SupplementSafety.org guide.
Minor updates
Updated guide wording, organization, and source presentation. Added our editorial change history.
Initial release
Initial SupplementSafety.org guide prepared from source reference material.
Validation: Not yet completed. Editorial updates do not constitute clinical validation.
Sources
Source information
This guide organizes source material about uses, preparations, amounts, and precautions. Read the conditions alongside each statement; the information may apply only to particular preparations or populations.
The source document includes supporting references. We have not independently summarized or assessed every cited study for this guide.
- Source document version
- July 31, 2026
- Source captured
- Aug 15, 2026
- Editorial work
- Editorial preparation. Independent clinical review has not been recorded for this guide.
Full citations are available through the link above. Verification is required to open them; reading this guide does not require verification.
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