Black Currant

Scientific Name(s): Ribes nigrum
Common Name(s): Black currant, Blackcurrant, European black currant, Gichtbeerblaetter, Johannisbeere (German), Kurokarin, Quincy berries, Schwarze (German), Siyah Frenkuzumu

Medically reviewed by Drugs.com. Last updated on Nov 12, 2024.

Clinical Overview

Use

Evidence is conflicting regarding the benefits of black currant as an antioxidant source and in night- and fatigue-related visual impairment. Two small published trials showed some benefit in rheumatoid arthritis, but black currant was not compared to a gold standard. Long-term safety and efficacy have not been studied for any of the above potential uses. Oil and juice extracts have also exhibited limited antimicrobial and prebiotic activities, as well as potential benefit in preventing infant atopic dermatitis, reducing cardiovascular risk, and improving certain exercise performance measures.

Dosing

Limited clinical trial data exist to provide dosage recommendations. Standardization of commercial products has usually been related to anthocyanin and/or vitamin C content. A tea made from 2 to 4 g of chopped leaves can be administered several times per day. Commercial extract products have been used at daily doses ranging from 300 mg to 6 g for 1 to 2 weeks for improvements in exercise performance and recovery. Black currant juice drinks with low (6.4%) and high (20%) juice concentrations have been administered at 250 mL/day for 6 weeks to improve cardiovascular risk parameters.

Contraindications

Contraindications have not been identified.

Pregnancy/Lactation

Information regarding safety and efficacy in pregnancy and lactation is lacking.

Interactions

None well documented.

Adverse Reactions

Self-limiting adverse reactions have been reported, including indigestion, loose bowels, and increased urinary frequency. Although no direct evidence is available, black currant should be used with caution in epileptic patients because lowered seizure threshold has been reported with evening primrose oil.

Toxicology

No data.

Scientific Family

Grossulariaceae (currant)

Botany

Black currant is a stout, woody, usually spineless, deciduous shrub native to northern Asia and central and eastern Europe and cultivated in the United States and throughout the world. The plant grows to an untrimmed height of about 1.2 to 2.1 m and has tooth-edged, maple-like leaves.Gopalan 2012 The fruits are resistant to cold or changing temperatures but do not thrive in hot or dry climates. Some Ribes species are fragrant, but R. nigrum possesses a strong, unpleasant odor. In spring, the flowers are yellowish-white, are shaped like small bells, and grow alternately in a row. In the fall, clusters of 4 to 6 black-red fruits ripen from the main branch and are used to make jams and jellies.van Wyk 2005 Ribes species in the Grossulariaceae (currant) family are sometimes included in the Saxifragaceae family.Määttä 2003, USDA 2013

History

Black current plant was first domesticated for its fruit approximately 400 to 500 years ago. It has been used in Chinese folk medicine as a diuretic, diaphoretic, and febrifuge. It has also been used as an ingredient in nutraceuticals, wines, juices, and jams in China and Europe.Matsumoto 2005, Suzutani 2003 It was used as a flavoring and coloring agent in syrupus ribis fructus, or "syrup of currants" (100 parts red currants, 10 parts red cherries, and 5 parts black currants).

An infusion of the leaves has been used in the treatment of edema, rheumatic pain, whooping cough, sore throat, and mouth ulcers. The fruits have been used as a source of vitamin C during the cold and flu seasonvan Wyk 2005; young roots and bark decoctions have also been used.

In the early 1900s, black currant farming was banned in the United States because the plant was considered to be a vector for fungi that caused white pine blister rust, which threatened the logging industry. In 2003, the ban was lifted in some states.Gopalan 2012

Chemistry

The chemical composition of the leaves, seeds, and berries of black currant has been determined using various analytical methods; these different methods have resulted in differences in reported concentrations of each component. Chemical content appears to vary within the species, but not necessarily as a consequence of the cultivation method (organic vs commercial).Del Castillo 2004, Mikkonen 2001, Nakajima 2004, Nielsen 2003

Aside from a high content of vitamin C (L-ascorbic acid),Rechner 2002 the berries contain flavonoids, including quercetin, myricetin, and kaempferol,Ehala 2005, Erlund 2003, Häkkinen 1998, Mikkonen 2001 as well as at least 15 different phenolic acids, including anthocyanins and proanthocyanidins.Ehala 2005, Maatta 2001, Määttä 2003, Nielsen 2003, Rechner 2002, Slimestad 2002, Wu 2004, Zadernowski 2005 Four major anthocyanins have been identified from black currant: delphinidin-3-O-glucoside, delphinidin-3-O-rutinoside, cyanidin-3-O-glucoside, and cyanidin-3-O-rutinosideGopalan 2012; p-coumaric acid is one of the predominant phenolic acids.Ehala 2005, Maatta 2001, Zadernowski 2005 The aroma of black currant juice extracts is attributed to the presence of terpenes, esters, and alcohols.Varming 2004

The oil from the seeds of the plant contains varying amounts (15% to 19%) of fatty acids: gamma- and alpha-linolenic acids and stearidonic acid,Del Castillo 2004, Dobson 2000 as well as anthocyanins, flavonoids, and 2 nitrile-containing compounds.Lu 2002 The leaves of the plant contain prodelphinidins.Garbacki 2002

The fruits contain high levels of minerals, including potassium, calcium, magnesium, and iron.Gopalan 2012

Uses and Pharmacology

Anticancer effects

In vitro data

An in vitro study found that black currant extract inhibited the proliferation of breast cancer cells and, to a lesser extent, colon cancer cells. An inverse relationship between vitamin C content and cancer cell proliferation was noted, with berry extracts with high vitamin C content inhibiting cancer cells to a greater extent.(Olsson 2004)

Also in vitro, black currant effectively inhibited the proliferation of various cancer cell lines, including Caco-2, MCF-7, AGS, and MDA-MB-231 cell lines (mammary gland, stomach, and colorectal adenocarcinomas).(Boivin 2007) In another in vitro study, black currant 20 mg/mL inhibited growth (20% reduction) of HT-29 colon cancer cells; specifically, expression of p21^WAF1, a cell proliferation inhibitor, increased 2.7-fold with black currant at a concentration of 40 mg/mL.(Wu 2007)

An aqueous extract of black currant fruit skin exerted a cytotoxic effect against HepG2 human liver cancer cells.(Bishayee 2010)

Clinical data

Research reveals no clinical data regarding black currant use in cancer. In a study small study of healthy subjects (N=30) to determine whether black currant used as a prebiotic positively modifies colonic microbiota, administration of black currant extract powder (Cassis Anthomix 30) 672 mg/day for 2 weeks significantly improved gut microbiota. The 24.4% decrease in activity of beta-glucuronidase, a biomarker for risk of colon cancer and a microbial enzyme known to increase the formation of carcinogens in the bowel, was statistically significantly improved compared with baseline (P<0.05).(Molan 2014)

Antimicrobial effects

In vitro data

In one study, black currant showed the least activity against gram-negative bacteria compared with other berries studied.(Puupponen-Pimiä 2001) In another study, it inhibited all tested bacteria.(Cavanagh 2003) A crude extract suppressed late-stage growth of influenza virus type A and B in canine kidney cells and inhibited release of the virus from infected cells.(Knox 2003) In another in vitro study, plaque formation, replication in cells, and the attachment of herpes simplex virus type 1 to cell membranes were inhibited.(Suzutani 2003)

Black currant extract inhibited replication of the respiratory syncytial, influenza type A and B, and herpes simplex type 1 viruses by more than 50%. A 10% spray of the extract disinfected 99.8% of Haemophilus influenzae virus type B and 78.9% of Streptococcus pneumonia but had no effect against Streptococcus mutans.(Ikuta 2012)

Antioxidant activity

The antioxidant activity of black currant berries and juice has been examined for potential cardiovascular and anticancer effects. Study results vary because of different analytical methods; the sugar content and pH of the juices tested also differ.(Maatta 2001, Matsumoto 2002, McGhie 2003)

The total antioxidant capacity of black currant berries is relatively high when compared with that of other berries. Antioxidant capacity closely correlates to total phenolic content(Ehala 2005, Nakajima 2004); however, individual phenolic compounds may contribute to differing extents.(Breinholt 2003, Joseph 2004, Matsumoto 2002, Viljanen 2004, Wu 2004) It has been suggested that the lipophilic antioxidant capacity is low, while the hydrophilic antioxidant capacity of phenolic compounds is higher.(Wu 2004) Vitamin C content is the major contributor to the antioxidant capacity of black currant.(Nielsen 2003)

Anthocyanins and flavonoids in black currant berries and juice have low bioavailability and are considered poor sources of antioxidants.(Erlund 2003, Mülleder 2002, Young 1999)

Animal and in vitro data

A correlation between vitamin C content and in vitro inhibition of cancer cell proliferation was found when examining antioxidant capacity.(Olsson 2004)

Black currant juice increased radical scavenging capacity in cultured macrophages.(Huebbe 2012)

In rats intoxicated with ethanol, black currant protected lipids and proteins against oxidation, possibly because of its ability to scavenge free radicals and chelate metal ions.(Szachowicz-Petelska 2012)

In a study of pigs, vitamin E appeared to be a more efficient antioxidant than black currant juice.(Salobir 2010)

Clinical data

No differences in antioxidant activity and biochemical markers were found in 22 elderly patients participating in a 2-week study of berry-enriched desserts.(Carmen Ramirez-Tortosa 2004) No difference was found in oxidative DNA damage in a 3-week trial of 60 healthy, adequately nourished adults receiving large amounts of berries in their diet.(Møller 2004) Similarly, no difference in antioxidant activity was observed between placebo and black currant anthocyanins (50 mg/day for 2 years) administered to patients with open-angle glaucoma.(Yoshida 2013) In a substudy of a larger double-blind, randomized, placebo-controlled trial, black currant dietary antioxidants did not provide any photoprotection at either low or high concentrations (6.4% and 20% juice) in healthy adults (N=32) who typically consumed low amounts of fruits and vegetables.(Ray 2016) In contrast, a study examining the effects of black currant on exercise-induced muscle damage demonstrated that the significantly decreased plasma antioxidant activity postexercise in untrained participants was mitigated in the group consuming black currant nectar (32 ounces/day [containing 200 g/day of fruit]) for 8 days (P=0.039 compared to placebo).(Hutchinson 2016)

Atopic dermatitis

Clinical data

In one study, supplementation with black currant seed oil in both mothers and 12-month-old infants resulted in a significant reduction in the prevalence of atopic dermatitis.(Foolad 2013) The cytokines in breast milk and their associations with black currant seed oil supplementation, mother's atopic status, and development of infant atopic dermatitis were assessed in 61 mothers and their infants chosen from the study population of a double-blind, randomized, placebo-controlled trial. Black currant supplementation in the mother during the eighth and 16th week of pregnancy and continued until the end of exclusive breastfeeding reduced interleukin 4 (IL-4) and increased interferon-gamma in breast milk significantly more than olive oil supplementation (P=0.044 and P=0.014, respectively). The breast milk of mothers whose children developed atopic dermatitis by 12 months of age had significantly lower levels of interferon-gamma (P=0.039) than the milk of mothers whose children did not develop dermatitis. Additionally, IL-10 levels in breast milk were significantly lower at 3 months in mothers who had atopic dermatitis (P=0.044).(Linnamaa 2013)

Cardiovascular risk factors

Clinical data

Black currant juice 300 mL/day for 5 days did not have acute effects on lipid parameters, the potent vasoconstrictor endothelin-1, hemostatic factors (ie, tissue plasminogen activator antigen [TPA-Ag], plasminogen activator inhibitor antigen [PAI-Ag]), or the inflammatory biomarker C-reactive protein in healthy male seminarians who were nonsmokers and lifelong abstainers from alcohol. In contrast, alcoholic drinks were observed to have acute effects, based on increases in TPA-Ag, PAI-Ag, and endothelin.(Banach 2013) In a double-blind, placebo-controlled, parallel-group design study assessing effects of dietary intake of black currant on oxidative stress and vascular function, consumption of 250 mL/day of a black currant juice drink for 6 weeks by healthy volunteers with average daily intake of no more than 2 servings of fruit and vegetables resulted in significant increases in plasma vitamin C levels (P<0.001). Compared with participants who received placebo or low-concentration (6.4%) black currant juice, those who consumed high-concentration (20%) black currant juice experienced a significant improvement in endothelial function, as observed by increases in flow-mediated dilation (FMD) (P=0.022). The increase in FMD was poorly correlated to the increase in plasma vitamin C levels (r=0.308, P=0.044).(Khan 2014) A randomized dose-response study of New Zealand black currant extract (CurraNZ; containing 105 mg of anthocyanin) administered at doses of 300, 600, and 900 mg/day for 7 days to endurance-trained males (N=15) revealed a dose effect on mean arterial pressure, cardiac output, stroke volume, and total peripheral resistance (P=0.023, P<0.001, P=0.014, and P=0.012, respectively).(Cook 2017)

Diabetic neuropathy

Animal data

In a study of diabetic rats, the effect of black currant oil on nerve conduction velocity was compared with that of other gamma-linolenic acid–containing oils, and black currant oil was found to have the least effect.(Dines 1996)

Exercise performance

Clinical data

In a few small, double-blind, randomized, placebo-controlled crossover trials conducted in athletes (study sizes ranging from 13 to 14 participants), benefit in some performance measures was demonstrated with short-term (7-day) consumption of New Zealand black currant extract.(Cook 2015, Perkins 2015, Willems 2015) Compared with placebo, New Zealand black currant extract 300 mg/day (CurraNZ; containing 105 mg/day of anthocyanins) was associated with a significant increase in mean number of sprints (from 32 to 35; P=0.02) and total distance covered (10% greater with extract vs placebo; P=0.023),(Perkins 2015) as well as in mean cycling completion time (P=0.027).(Cook 2015) However, results regarding black currant's effects on physiological parameters have been equivocal; no interaction effect on physiological response, perceptual response, or recovery was found with 300 mg/day,(Perkins 2015) whereas improvements in fat oxidation, lactate response, and resting cardiovascular function (ie, stroke volume, cardiac output) were observed in other studies using New Zealand black currant extracts (CurraNZ 300 mg/day or Sujon [black currant powder containing 138.6 mg of anthocyanin] 6 g/day dissolved in water).(Cook 2015, Willems 2015) None of these studies demonstrated an interaction effect on cardiovascular function during performance.

In a small, double-blind, randomized, placebo-controlled study of untrained healthy young adults 18 to 40 years of age (N=16), consumption of black currant nectar (32 oz/day; containing 200 g/day of fruit) for 8 days was investigated for its effects on muscle damage and inflammation following a session of high-intensity leg squats. Changes in the biomarkers for inflammation (IL-6) and muscle damage (creatine kinase) were significantly improved with the intervention. Additionally, plasma antioxidant capacity was maintained at 48 hours postexercise with consumption of black currant nectar, compared with significant decreases in the placebo group (P=0.039).(Hutchinson 2016)

Glycemic effects

In vitro data

Black currant inhibited alpha-glucosidase, with effects similar to those of acarbose, suggesting potential dietary use for glycemic control in type 2 diabetes.(Boath 2012)

Clinical data

In a randomized, controlled, crossover study of 20 healthy women, consumption of black currants or lingonberries was associated with an improvement in glycemic profile; specifically a reduced late postprandial hypoglycemic response was observed.(Törrönen 2012)

Gout

The 2012 American College of Rheumatology guidelines on the management of gout state that the use of various oral complementary agents, including black currant, is inappropriate for the treatment of an acute gout attack. The new guideline (2020) based on additional evidence regarding the management of gout no longer included a statement regarding the use of black currant.(Fitzgerald 2020, Khanna 2012)

Immune response

Clinical data

In a study evaluating the effects of black currant on the immune response of healthy elderly subjects, a dosage of six 750 mg capsules daily (4.5 g/day) of black currant seed oil (as a source of gamma-linolenic acid) did not adversely affect immune response and may have a moderate immunoenhancing effect due, in part, to its reduction of prostaglandin E₂ production.(Wu 1999)

Lipid profile effects

Animal and in vitro data

In vitro and animal studies evaluating the effects of black currant extracts and anthocyanins on lipid profiles produced varying (both positive and negative) results on cholesterol and triglycerides.(Barre 2001, Finné Nielsen 2005, Frank 2002)

Clinical data

In a clinical trial assessing effects of dietary intake of a black currant juice drink on oxidative stress and vascular function in healthy subjects, no effects on cholesterol and triglycerides were observed.(Khan 2014) In another study in 15 healthy females, black currant seed oil produced positive effects on plasma lipids.(Tahvonen 2005) Links with positive cardiovascular effects have not been established.

Periodontal disease

In vitro data

Pretreatment with black currant extract exerted cytoprotective effects against nicotine in oral epithelial cells and fibroblasts. The study authors concluded that black currant may have a role in the prevention and/or treatment of periodontal diseases resulting from smoking.(Desjardins 2012)

Prebiotic effects

Clinical data

Administration of black currant extract powder (Cassis Anthomix 30) 672 mg/day for 2 weeks significantly improved gut microbiota in a small group of healthy subjects (N=30). Compared with baseline, population sizes of gut microbes associated with improved health, specifically Lactobacillus and Bifidobacterium species, increased significantly (P<0.0001), whereas those associated with poor health, specifically Clostridium and Bacteroides species, decreased significantly (P<0.0001). Microbial enzyme activity that likely reflected increased activity of lactobacilli increased significantly at 2 weeks and remained significantly increased for 2 weeks after discontinuation of black currant extract powder (P<0.05). The 24.4% decrease in activity of beta-glucuronidase, a biomarker for risk of colon cancer and a microbial enzyme known to increase the formation of carcinogens in the bowel, was also statistically significant compared with baseline (P<0.05).(Molan 2014)

Rheumatoid arthritis

Animal and in vitro data

The anti-inflammatory effects of black currant seed oil and prodelphinidins from the leaves have been studied in animal and in vitro settings.(Barre 2001, Garbacki 2002, Garbacki 2004) In cultured macrophages, black currant juice exerted anti-inflammatory effects, as evidenced by reduced levels of tissue necrosis factor alpha, IL-1beta, and inducible nitric oxide synthase.(Huebbe 2012)

Clinical data

A Cochrane review of trial data suggests some benefit from gamma-linolenic acid in rheumatoid arthritis, despite the relatively poor quality of the individual studies.(Little 2001) A trend toward reduction of morning stiffness and joint tenderness, as well as pain relief, was shown. Sufficient evidence was found to warrant larger trials to provide further information regarding outcomes, optimal dosage, and duration of therapy.(Little 2001) Two randomized, controlled trials using black currant seed oil were included in the review.(Leventhal 1994, Watson 1993)

Urolithiasis

Clinical data

In a small study in healthy male subjects (N=12), black currant berries increased urine pH (alkalinizing effect), as well as citric and oxalic acid secretion.(Kessler 2002)

Vision

Animal and in vitro data

In in vitro studies, black currant anthocyanins accelerated the regeneration of rhodopsin and produced sustained and progressive relaxation of bovine myopic ciliary muscle.(Matsumoto 2003, Matsumoto 2005) A dose-dependent inhibition of enlargement of the vitreous chamber depth, as well as of axial and ocular lengths, occurred in chicks administered black currant extract.(Iida 2010)

Clinical data

In a double-blind crossover trial involving 12 subjects, a single dose of a black currant anthocyanin extract (12.5 mg, 20 mg, or 50 mg) showed a dose-dependent effect on lowering the dark adaptation threshold.(Nakaishi 2000)

In a randomized, double-blind, placebo-controlled trial, 40 patients with open-angle glaucoma were randomized to receive 50 mg/day of black currant anthocyanins or placebo for 2 years. The mean deterioration from baseline in Humphrey visual field mean deviation was lower in patients receiving black currant compared with those receiving placebo.(Ohguro 2012) The effects of black currant anthocyanins on intraocular pressure compared to placebo were assessed in 21 glaucoma patients drawn from this same group of 40 patients. Black currant anthocyanins 50 mg/day was associated with a reduction in intraocular pressure at 2 and 4 weeks, as well as after 24 months of treatment. No effects on blood pressure and pulse were noted.(Ohguro 2013) In order to explore mechanisms of black currant anthocyanins in glaucomatous optic neuropathy, blood samples from the 38 patients who completed the initial trial were used to determine the effects of black currant anthocyanins on serum biomarkers regulating vessel contraction and antioxidative stress. Compared with placebo, patients receiving the anthocyanins experienced an increase in serum endothelin-1 to levels comparable with healthy controls. However, no changes were observed in metabolites of nitric oxide, advanced oxidative protein products, and serum antioxidant activity.(Yoshida 2013)

Dosing

Cardiovascular disease risk factors

Black currant juice 300 mL/day for 5 days was used in a study evaluating the effects of various beverages on several cardiovascular disease risk parameters.Banach 2013 In a study of healthy volunteers to assess the effects of dietary intake of black currant juice on oxidative stress and vascular function, 250 mL/day of low-concentration (6.4%) or high-concentration (20%) black currant juice drink was administered for 6 weeks.Khan 2014 In another study, New Zealand black currant extract (CurraNZ; containing 105 mg of anthocyanin) was administered at doses of 300, 600, and 900 mg/day to endurance-trained males to evaluate effects on cardiovascular function/cardiovascular risk (mean arterial pressure, cardiac output, stroke volume, and total peripheral resistance).Cook 2017

Exercise-induced muscle damage

32 oz/day of black current nectar (approximately 946 mL/day, containing 200 g/day of fruit) for 8 days was administered to evaluate its effects on exercise-induced muscle damage (ie, inflammatory status, oxidative stress).Hutchinson 2016

Exercise performance

In short-term studies investigating effects on exercise performance and recovery, A New Zealand black currant extract (CurraNZ; containing 105 mg of anthocyanin) has been dosed at 300 mg/day for 7 days,Cook 2015, Perkins 2015 while another New Zealand black currant powder (Sujon; containing 138.6 mg of anthocyanin) dissolved in water has been administered at a dosage of 6 g/day for 7 days.Willems 2015

Immune response

A dosage of six 750 mg capsules daily (4.5 g/day) of black currant seed oil (as a source of gamma-linolenic acid) was used to evaluate effects on immune response of healthy elderly subjects.Wu 1999

Prebiotic

Black currant extract powder (Cassis Anthomix 30) 672 mg/day for 2 weeks has been used to promote growth of beneficial bacteria.Molan 2014

Rheumatoid arthritis

Black currant seed oil equivalent to gamma-linolenic acid 525 mg was used for 6 weeks in one rheumatoid arthritis trial,Watson 1993 and 10.5 g of oil daily for 24 weeks was used in another trial.Leventhal 1994

Urolithiasis

330 mL of black currant juice was administered daily in a small trial investigating the effects on urolithiasis risk factors.Kessler 2002

Pregnancy / Lactation

Information regarding safety and efficacy in pregnancy and lactation is lacking.

Interactions

Because gamma-linolenic acid decreased platelet aggregation and increased bleeding times in rats fed evening primrose oil, theoretically an interaction between black currant oil and anticoagulants such as warfarin is possible.Norred 2001 Other in vitro studies add to this consideration.Barre 2001, Pregnolato 1996

Adverse Reactions

Black currant ingestion was associated with an oral allergy syndrome in a patient with allergy to grass pollen. In one case report, a 50-year-old woman developed pruritus and dysphagia following ingestion of fresh red and black currant jam, with similar reactions following ingestion of apricot, peach, and nectarine juice and jam.Pérez-Ezquerra 2007 Although no direct evidence is available, black currant should be used with caution in epileptic patients because lowered seizure threshold has been reported with evening primrose oil.Ernst 2002, Vaddadi 1981, Werneke 2004 Self-limiting symptoms of indigestion, loose bowels, and increased urinary frequency were reported by a few patients after consumption of 250 mL/day of black currant juice for 6 weeks in a clinical trial.Khan 2014

Toxicology

No data.

Index Terms

Saxifragaceae

References

Disclaimer

This information relates to an herbal, vitamin, mineral or other dietary supplement. This product has not been reviewed by the FDA to determine whether it is safe or effective and is not subject to the quality standards and safety information collection standards that are applicable to most prescription drugs. This information should not be used to decide whether or not to take this product. This information does not endorse this product as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this product. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this product. This information is not specific medical advice and does not replace information you receive from your health care provider. You should talk with your health care provider for complete information about the risks and benefits of using this product.

This product may adversely interact with certain health and medical conditions, other prescription and over-the-counter drugs, foods, or other dietary supplements. This product may be unsafe when used before surgery or other medical procedures. It is important to fully inform your doctor about the herbal, vitamins, mineral or any other supplements you are taking before any kind of surgery or medical procedure. With the exception of certain products that are generally recognized as safe in normal quantities, including use of folic acid and prenatal vitamins during pregnancy, this product has not been sufficiently studied to determine whether it is safe to use during pregnancy or nursing or by persons younger than 2 years of age.

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