The GRAS Substances (SCOGS) Database allows access to opinions and conclusions from 115 SCOGS reports published between 1972-1980 on the safety of over 370 Generally Recognized As Safe (GRAS) food substances. The GRAS ingredient reviews were conducted by the Select Committee in response to a 1969 White House directive by President Richard M. Nixon.
Nutmeg and Mace
- SCOGS-Report Number: 18*
- Type Of Conclusion: 3
- ID Code: 977051-44-7; 977051-14-1
- Year: 1973
- 21 CFR Section: 182.10
The toxic and alleged psychogenic effects of nutmeg and some of its pharmacologically active constituents such as myristicin, elemicin, and safrole are clearly manifested only at doses vastly greater than the usual levels of intake in the human diet. Historically the toxic effects of massive doses (10 or more grams) of nutmeg when taken as an emmenagogue, abortifacient, or hallucinogen, although distressing, are transient and rarely fatal. However, it is to be recognized that as much as 6 percent of safrole, a weak hepatocarcinogen, is reported to be present in the essential oil of East Indian nutmeg, the major U.S. source. In 1960 FDA prohibited the use of safrole in food. Moreover, the closely related methoxy derivative of safrole, myristicin, is also present in some nutmeg oils in amounts approximating 5 percent.
Our calculations (Section III of this report) indicate that the intake level of nutmeg oil and its equivalent in the form of nutmeg and mace, based on the total imports available annually for use in food in the U.S., is of the order of 0.05 mg per kg per day for adults. Assuming a maximum content of 6 percent safrole in the oil, possible daily intake of safrole would be about 4 mcg per kg per day for an adult and about 5 times this amount for a child 6-11 months of age, who, according to the NRC survey, consumes the largest amounts of nutmeg products per kg of body weight. If myristicin is capable of conversion to safrole in vivo, intakes could be about double these amounts. All of these intake estimates would be low, of course, for any in the population who are particularly heavy consumers of food products containing nutmeg.
While there is no evidence that such levels of consumption are capable of eliciting adverse effects, it is the opinion of the Select Committee that the safrole and myristicin content of nutmeg products, and perhaps the content of such related constituents as elemicin, eugenol, and methoxyeugenol, should be further investigated to determine the range of content in both the East and West Indian products and to investigate or reinvestigate their possible mutagenic, teratogenic, and carcinogenic effects.
The Select Committee has weighed the foregoing and concludes that:
While no evidence in the available information on nutmeg, mace, or their essential oils demonstrates a hazard to the public when they are used in the manner now practiced, uncertainties exist requiring that additional studies should be conducted.
*Complete reports containing details of the safety studies that formed the basis of the opinions and conclusions and are available from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161 (703) 605-6000.