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.
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, 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.
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.