Scroll Top
ESSENTIAL OILS
Generally Recognized as Safe (GRAS) by the U.S. Food and Drug Administration

ESSENTIAL OILS GENERALLY RECOGNIZED AS SAFE (GRAS)

The U.S. Food and Drug Administration (FDA) regulates approximately 80% of the U.S. food supply, and is involved with many facets of food safety. Within FDA, the Center for Food Safety and Applied Nutrition’s (CFSAN) Office of Food Additive Safety is responsible for reviewing safety information for food ingredients and food packaging.

GRAS Determination vs. Food Additive Safety Determination

For a substance to be GRAS, the scientific data and information about the use of a substance must be widely known, and there must be a consensus among qualified experts that those data and information establish that the substance is safe under the conditions of its intended use.

However, for a food additive, privately held data and information about the use of a substance are sent by the sponsor to FDA, which evaluates those data and information to determine whether they establish that the substance is safe under the conditions of its intended use.

Thus, for a food additive, FDA determines the safety of the ingredient, whereas a determination that an ingredient is GRAS can be made by qualified experts outside of government.

Essential Oils List

Essential oils, oleoresins (solvent-free), and natural extractives (including distillates) that are generally recognized as safe for their intended use, by the U.S. Food and Drug Administration (U.S. FDA), are as follows:

Alfalfa

Botanical name of plant source

Medicago sativa L.

Allspice

Botanical name of plant source

Pimenta officinalis Lindl.

Almond, bitter (free from prussic acid)

Botanical name of plant source

Prunus amygdalus Batsch, Prunus armeniaca L., or Prunus persica (L.) Batsch.

Ambrette (seed)

Botanical name of plant source

Hibiscus moschatus Moench.

Angelica root

Botanical name of plant source

Angelica archangelica L.

Angelica seed

Botanical name of plant source

Do.

Angelica stem

Botanical name of plant source

Do.

Angostura (cusparia bark)

Botanical name of plant source

Galipea officinalis Hancock.

Anise

Botanical name of plant source

Pimpinella anisum L.

Asafetida

Botanical name of plant source

Ferula assa-foetida L. and related spp. of Ferula.

Balm (lemon balm)

Botanical name of plant source

Melissa officinalis L.

Balsam of Peru

Botanical name of plant source

Myroxylon pereirae Klotzsch.

Basil

Botanical name of plant source

Ocimum basilicum L.

Bay leaves

Botanical name of plant source

Laurus nobilis L.

Bay (myrcia oil)

Botanical name of plant source

Pimenta racemosa (Mill.) J. W. Moore.

Bergamot (bergamot orange)

Botanical name of plant source

Citrus aurantium L. subsp. bergamia Wright et Arn.

Bitter almond (free from prussic acid)

Botanical name of plant source

Prunus amygdalus Batsch, Prunus armeniaca L., or Prunus persica (L.) Batsch.

Bois de rose

Botanical name of plant source

Aniba rosaeodora Ducke.

Cacao

Botanical name of plant source

Theobroma cacao L.

Camomile (chamomile) flowers, Hungarian

Botanical name of plant source

Matricaria chamomilla L.

Camomile (chamomile) flowers, Roman or English

Botanical name of plant source

Anthemis nobilis L.

Cananga

Botanical name of plant source

Cananga odorata Hook. f. and Thoms.

Capsicum

Botanical name of plant source

Capsicum frutescens L. and Capsicum annuum L.

Caraway

Botanical name of plant source

Carum carvi L.

Cardamom seed (cardamon)

Botanical name of plant source

Elettaria cardamomum Maton.

Carob bean

Botanical name of plant source

Ceratonia siliqua L.

Carrot

Botanical name of plant source

Daucus carota L.

Cascarilla bark

Botanical name of plant source

Croton eluteria Benn.

Cassia bark, Chinese

Botanical name of plant source

Cinnamomum cassia Blume.

Cassia bark, Padang or Batavia

Botanical name of plant source

Cinnamomum burmanni Blume.

Cassia bark, Saigon

Botanical name of plant source

Cinnamomum loureirii Nees.

Celery seed

Botanical name of plant source

Apium graveolens L.

Cherry, wild, bark

Botanical name of plant source

Prunus serotina Ehrh.

Chervil

Botanical name of plant source

Anthriscus cerefolium (L.) Hoffm.

Chicory

Botanical name of plant source

Cichorium intybus L.

Cinnamon bark, Ceylon

Botanical name of plant source

Cinnamomum zeylanicum Nees.

Cinnamon bark, Chinese

Botanical name of plant source

Cinnamomum cassia Blume.

Cinnamon bark, Saigon

Botanical name of plant source

Cinnamomum loureirii Nees.

Cinnamon leaf, Ceylon

Botanical name of plant source

Cinnamomum zeylanicum Nees.

Cinnamon leaf, Chinese

Botanical name of plant source

Cinnamomum cassia Blume.

Cinnamon leaf, Saigon

Botanical name of plant source

Cinnamomum loureirii Nees.

Citronella

Botanical name of plant source

Cymbopogon nardus Rendle.

Citrus peels

Botanical name of plant source

Citrus spp.

Clary (clary sage)

Botanical name of plant source

Salvia sclarea L.

Clover

Botanical name of plant source

Trifolium spp.

Coca (decocainized)

Botanical name of plant source

Erythroxylum coca Lam. and other spp. of Erythroxylum.

Coffee

Botanical name of plant source

Coffea spp.

Cola nut

Botanical name of plant source

Cola acuminata Schott and Endl., and other spp. of Cola.

Coriander

Botanical name of plant source

Coriandrum sativum L.

Cumin (cummin)

Botanical name of plant source

Cuminum cyminum L.

Curacao orange peel (orange, bitter peel)

Botanical name of plant source

Citrus aurantium L.

Cusparia bark

Botanical name of plant source

Galipea officinalis Hancock.

Dandelion

Botanical name of plant source

Taraxacum officinale Weber and T. laevigatum DC.

Dandelion root

Botanical name of plant source

Do.

Dog grass (quackgrass, triticum)

Botanical name of plant source

Agropyron repens (L.) Beauv.

Elder flowers

Botanical name of plant source

Sambucus canadensis L. and S. nigra I.

Estragole (esdragol, esdragon, tarragon)

Botanical name of plant source

Artemisia dracunculus L.

Estragon (tarragon)

Botanical name of plant source

Do.

Fennel, sweet

Botanical name of plant source

Foeniculum vulgare Mill.

Fenugreek

Botanical name of plant source

Trigonella foenum-graecum L.

Galanga (galangal)

Botanical name of plant source

Alpinia officinarum Hance.

Geranium

Botanical name of plant source

Pelargonium spp.

Geranium, East Indian

Botanical name of plant source

Cymbopogon martini Stapf.

Geranium, rose

Botanical name of plant source

Pelargonium graveolens L’Her.

Ginger

Botanical name of plant source

Zingiber officinale Rosc.

Grapefruit

Botanical name of plant source

Citrus paradisi Macf.

Guava

Botanical name of plant source

Psidium spp.

Hickory bark

Botanical name of plant source

Carya spp.

Horehound (hoarhound)

Botanical name of plant source

Marrubium vulgare L.

Hops

Botanical name of plant source

Humulus lupulus L.

Horsemint

Botanical name of plant source

Monarda punctata L.

Hyssop

Botanical name of plant source

Hyssopus officinalis L.

Immortelle

Botanical name of plant source

Helichrysum augustifolium DC.

Jasmine

Botanical name of plant source

Jasminum officinale L. and other spp. of Jasminum.

Juniper (berries)

Botanical name of plant source

Juniperus communis L.

Kola nut

Botanical name of plant source

Cola acuminata Schott and Endl., and other spp. of Cola.

Laurel berries

Botanical name of plant source

Laurus nobilis L.

Laurel leaves

Botanical name of plant source

Laurus spp.

Lavender

Botanical name of plant source

Lavandula officinalis Chaix.

Lavender, spike

Botanical name of plant source

Lavandula latifolia Vill.

Lavandin

Botanical name of plant source

Hybrids between Lavandula officinalis Chaix and Lavandula latifolin Vill.

Lemon

Botanical name of plant source

Citrus limon (L.) Burm. f.

Lemon grass

Botanical name of plant source

Cymbopogon citratus DC. and Cymbopogon lexuosus Stapf.

Lemon peel

Botanical name of plant source

Citrus limon (L.) Burm. f.

Lime

Botanical name of plant source

Citrus aurantifolia Swingle.

Linden flowers

Botanical name of plant source

Tilia spp.

Locust bean

Botanical name of plant source

Ceratonia siliqua L.

Lupulin

Botanical name of plant source

Humulus lupulus L.

Mace

Botanical name of plant source

Myristica fragrans Houtt.

Mandarin

Botanical name of plant source

Citrus reticulata Blanco.

Marjoram, sweet

Botanical name of plant source

Majorana hortensis Moench.

Mate

Botanical name of plant source

Ilex paraguariensis St. Hil.

Menthol

Botanical name of plant source

Mentha spp.

Menthyl acetate

Botanical name of plant source

Do.

Molasses (extract)

Botanical name of plant source

Saccarum officinarum L.

Mustard

Botanical name of plant source

Brassica spp.

Naringin

Botanical name of plant source

Citrus paradisi Macf.

Neroli, bigarade

Botanical name of plant source

Citrus aurantium L.

Nutmeg

Botanical name of plant source

Myristica fragrans Houtt.

Onion

Botanical name of plant source

Allium cepa L.

Orange, bitter, flowers

Botanical name of plant source

Citrus aurantium L.

Orange, bitter, peel

Botanical name of plant source

Do.

Orange leaf

Botanical name of plant source

Citrus sinensis (L.) Osbeck.

Orange, sweet

Botanical name of plant source

Do.

Orange, sweet, flowers

Botanical name of plant source

Do.

Orange, sweet, peel

Botanical name of plant source

Do.

Origanum

Botanical name of plant source

Origanum spp.

Palmarosa

Botanical name of plant source

Cymbopogon martini Stapf.

Paprika

Botanical name of plant source

Capsicum annuum L.

Parsley

Botanical name of plant source

Petroselinum crispum (Mill.) Mansf.

Pepper, black

Botanical name of plant source

Piper nigrum L.

Pepper, white

Botanical name of plant source

Do.

Peppermint

Botanical name of plant source

Mentha piperita L.

Peruvian balsam

Botanical name of plant source

Myroxylon pereirae Klotzsch.

Petitgrain

Botanical name of plant source

Citrus aurantium L.

Petitgrain lemon

Botanical name of plant source

Citrus limon (L.) Burm. f.

Petitgrain mandarin or tangerine

Botanical name of plant source

Citrus reticulata Blanco.

Pimenta

Botanical name of plant source

Pimenta officinalis Lindl.

Pimenta leaf

Botanical name of plant source

Pimenta officinalis Lindl.

Pipsissewa leaves

Botanical name of plant source

Chimaphila umbellata Nutt.

Pomegranate

Botanical name of plant source

Punica granatum L.

Prickly ash bark

Botanical name of plant source

Xanthoxylum (or Zanthoxylum) Americanum Mill. or Xanthoxylum clava-herculis L.

Rose absolute

Botanical name of plant source

Rosa alba L., Rosa centifolia L., Rosa damascena Mill., Rosa gallica L., and vars. of these spp.

Rose (otto of roses, attar of roses)

Botanical name of plant source

Do.

Rose buds

Botanical name of plant source

Do.

Rose flowers

Botanical name of plant source

Do.

Rose fruit (hips)

Botanical name of plant source

Do.

Rose geranium

Botanical name of plant source

Pelargonium graveolens L’Her.

Rose leaves

Botanical name of plant source

Rosa spp.

Rosemary

Botanical name of plant source

Rosmarinus officinalis L.

Saffron

Botanical name of plant source

Crocus sativus L.

Sage

Botanical name of plant source

Salvia officinalis L.

Sage, Greek

Botanical name of plant source

Salvia triloba L.

Sage, Spanish

Botanical name of plant source

Salvia lavandulaefolia Vahl.

St. John’s bread

Botanical name of plant source

Ceratonia siliqua L.

Savory, summer

Botanical name of plant source

Satureia hortensis L.

Savory, winter

Botanical name of plant source

Satureia montana L.

Schinus molle

Botanical name of plant source

Schinus molle L.

Sloe berries (blackthorn berries)

Botanical name of plant source

Prunus spinosa L.

Spearmint

Botanical name of plant source

Mentha spicata L.

Spike lavender

Botanical name of plant source

Lavandula latifolia Vill.

Tamarind

Botanical name of plant source

Tamarindus indica L.

Tangerine

Botanical name of plant source

Citrus reticulata Blanco.

Tarragon

Botanical name of plant source

Artemisia dracunculus L.

Tea

Botanical name of plant source

Thea sinensis L.

Thyme

Botanical name of plant source

Thymus vulgaris L. and Thymus zygis var. gracilis Boiss.

Thyme, white

Botanical name of plant source

Do.

Thyme, wild or creeping

Botanical name of plant source

Thymus serpyllum L.

Triticum (see dog grass)

Botanical name of plant source

Tuberose

Botanical name of plant source

Polianthes tuberosa L.

Turmeric

Botanical name of plant source

Curcuma longa L.

Vanilla

Botanical name of plant source

Vanilla planifolia Andr. or Vanilla tahitensis J. W. Moore.

Violet flowers

Botanical name of plant source

Viola odorata L.

Violet leaves

Botanical name of plant source

Do.

Violet leaves absolute

Botanical name of plant source

Do.

Wild cherry bark

Botanical name of plant source

Prunus serotina Ehrh.

Ylang-ylang

Botanical name of plant source

Cananga odorata Hook. f. and Thoms.

Zedoary bark

Botanical name of plant source

Curcuma zedoaria Rosc.

 

 

FDA Warning Letters

You sould be aware that the U.S. Food and Drug Administration reviews:

  • Websites
  • Social media platforms including Instagram, Facebook, LinkedIn, Twitter

If your products are intended for use in the cure, mitigation, treatment, or prevention of disease, then they will be considered drugs. The intended use of a product may be determined by, among other things, its labeling, advertising, and the circumstances surrounding its distribution.

Evidence of the intended uses of your products as drugs include, but may not be limited to, the following:

  • “May ease symptoms of discomfort from a urinary tract infection”
  • “May ease symptoms of discomfort from a yeast infection”
  • “Great to use for a homemade sunscreen”
  • “As effective as pills for the kidney stones”
  • “Use (especially along with lavender and peppermint) to ease those seasonal sniffles and runny noses”
  • “Can be used to combat acne”
  • “May reduce inflammation”
  • “Could help with allergy symptoms like post-nasal drip, sneezing and itchy eyes”
  • “Can help with arthritis and asthma”

Generally, self-diagnosis or treatment by individuals who are not medical practitioners of urinary tract infection, yeast infection, high cholesterol, high blood pressure, cancer, kidney stones, addiction, Alzheimer’s, anxiety, depression, chronic pain, diabetes, drug withdrawal, epilepsy, glaucoma, and Parkinson’s disease.

These products are unapproved new drugs, and the introduction or delivery for introduction into interstate commerce of misbranded drugs is illegal. Furthermore, these products would not meet the requirements under which certain nonprescription drug products may be marketed without an approved new drug application.

Failure to adequately address any violations or complete corrective actions within 15 working days, may result in legal action including seizure and injunction.

CONTACT ITB HOLDINGS LLC