Capsaicin

What Is It?

Capscium Annuum ExtractThe mixture of substances drawn out of a material by solution, heat, or another physical or chemical process., Capscium Annuum Fruit Extract, Capsicum Annuum ResinA class of solid or semi-solid viscous organic substances exuded by plants. Sometimes refers to a class of synthetic products with physical properties similar to those of natural resins., Capsicum Annuum Fruit Powder, Capsicum Frutescens Fruit, Capsicum Frutescens Fruit Extract and Capsicum Frutescens Resin are derived from the plant or the fruit of hot peppers. Capsicum Fruit Extracts and Resins vary from yellowish to reddish-brown viscous liquids. Capsaicin is a compound that is isolated from hot peppers. Capsaicin is responsible for the hot burning feeling that results when you eat or handle a hot pepper. In cosmetics and personal care products, Capsicum-derived ingredients are used in the formulation of shampoos and hair products, as well as skin care, cleansing, and bath products.

Why Is It Used?

The following functions have been reported for the Capsicum-derived ingredients.

Antidandruff agentIngredients that help to control dandruff, seborrheic dermatitis, and psoriasis. In the United States, antidandruff agents are regulated as Over-The-Counter (OTC) drug ingredients. – Capsicum Annuum Fruit Extract
Antifungal agentIngredients that inhibit the growth and reproduction of fungal cells and decrease the number of fungi present. In the United States, antifungal agents are regulated as Over-The-Counter (OTC) drug ingredients. – Capsicum Annuum Fruit Extract
Antimicrobial agentIngredients that kill microorganisms, or prevent or inhibit their growth and reproduction. In the United States, antimicrobial agents are regulated as Over-The-Counter (OTC) drug ingredients. – Capsicum Annuum Fruit Extract
AntioxidantIngredients that prevent or slow deterioration due to chemical reaction with oxygen. – Capsicum Annuum Fruit Extract
Cosmetic astringentIngredients that induce a tightening or tingling sensation of the skin. – Capsicum Annuum Fruit Extract
External analgesicIngredients that are applied to the skin to relieve pain. In the United States, external analgesics are regulated as Over-The-Counter (OTC) drug ingredients. – Capsaicin
Hair conditioning agentIngredients that enhance the appearance and feel of hair, by increasing hair body, suppleness, or sheen, or by improving the texture of hair that has been damaged physically or by chemical treatment. – Capsicum Annuum Fruit Extract Skin conditioning agent – miscellaneous – Capsicum Annuum Extract,Capsicum Annuum Resin, Capsicum Annuum Fruit Powder, Capsicum Frutescens Fruit Extract, Capsaicin
Skin protectantAn ingredient that temporarily protects injured or exposed skin from harmful or annoying stimuli, and that may provide relief to such skin. In the United States, skin protectants are regulated as Over-The-Counter (OTC) drug ingredients. – Capsicum Annuum Fruit Extract

Scientific Facts

Capsicum Extracts, Fruit Extracts, and Resins are derived from the plant, fruit or dried fruit, respectively, of Capsicum annuum or Capsicum frutescens. Capsicum Frutescens Resin is also referred to as Capsicum Oleoresin. Capsaicin, isolated from hot peppers, is the compound responsible for the burning feeling when you eat hot peppers.

Safety Information

The Food and Drug Administration (FDA) includes Capscium (Capscium frutescens or Capsicum annuum on its list of substances considered Generally Recognized As Safe (GRAS“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.) as direct food additives. They are GRAS spices and other natural seasonings and flavorings, and GRAS essential oleoresins and natural extractives. Capsicum, Capsicum Resin and Capsaicin are also approved for use as counterirritants in Over-The-Counter (OTC) external analgesic drug products. The safety of Capsicum-derived ingredients has been assessed by the Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Capsaicin, Capsicum Annuum Extract, Capsicum Annuum Fruit Extract, Capsicum Annuum Resin, Capsicum Annuum Fruit Powder, Capsicum Frutescens Fruit, Capsicum Frutescens Fruit Extract and Capsicum Frutescens Resin were safe as cosmetics ingredients when formulated not to be irritating.

CIR Safety Review: The CIR Expert Panel acknowleged the large amount of data on Capsaicin. They noted the wide use of hot peppers as food, and this use as well as oral laboratory studies supported the lack of systemic effects following dietary exposure to hot peppers. An ethanol extract of red chili was mutagenic in one strain of S. typhimurium, but not in another strain, or in E. coli.

Capsaicin and extracts from hot peppers have been shown to be irritating to mucosal tissues, inclding the stomach, as well as the skin. A skin irritation test of Capsicum Annuum Fruit Extract at concentrations ranging from 0.1 to 1.0% produced no irritation. Clinical findings include symptoms of cough, sneezing and runny nose in chili factory workers. Human respiratory responses to Capsicum OleoresinA natural plant product containing essential oil and resin. spray include burning of the throat, wheezing, dry cough, shortness of breath, gaging, gasping, inability to breathe or speak, and, rarely, cyanosis, apnea, and respiratory arrest.

A trade name mixture containing 1 to 5% Capsicum Frutescens Fruit Extract induced very slight erythema in one of ten volunteers patch tested for 48 hours. Capsicum Frutescens Fruit Extract at 0.025% in a repeated insult patch test using 103 subjects resulted in no clinically meaningful irritation or allergic contact dermatitis. One epidemiological study indicated that chili pepper consumption may be a strong risk factor for gastric cancer in populations with high intakes of chili pepper; however, other studies did not find this association. The CIR Expert Panel noted that n-nitroso compounds had been detected in a number of pepper samples, and recommended that the derivatives of Capsicum not be used in products where N-Nitroso compounds may be formed.

More information about nitrosamines.

Link to the FDA Code of Federal Regulations and Federal Register for Capsicum (Capsicum furtescens or Capsicum annuum) and Capsaicin

The Capsicum-derived ingredients may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European UnionUnder the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions..

Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…

More Scientific Information

The Capsicum-derived ingredients used in cosmetics and personal care products, may be extracted using hexane, ethanol, or vegetable oil and contain the full range of phytocompounds that are found in the Capsicum annuum or Capsicum frutescens fruit, including Capsaicin. In cosmetics and personal care products, Capsicum-derived ingredients function primarily as skin-conditioning agents – miscellaneous.

Resources

Find out more about the regulation of over-the-counter drugs by the Food and Drug Administration

OTC Drug Home Page: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSa…

Information about OTC Drug monographs: https://www.fda.gov/drugs/over-counter-otc-drug-monograph-process

Find out more about the regulation of Food Additives by the Food and Drug Administration

Food Ingredients and Packaging: http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm

Food Contact Substances: http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/defaul…

Substances Generally Recognized As Safe (GRAS): http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/default.htm

Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/