What guidance does FDA have for manufacturers of Spices, Spice Seeds and Herbs?

This group includes food materials that particularly need protection from various animal pests. They may also become moldy or otherwise decomposed unless properly prepared and stored. The Federal Food, Drug, and Cosmetic Act requires emphasis on the principle of "clean" food, not "cleaned" food. One of the most serious consequences of failure to protect herbs and spices is contamination with excreta from rats, mice, birds, or other animals. Emphasis should be placed on harvesting, storing, handling, packing, and shipping under conditions which will prevent contamination.

The same basic principle of prevention applies in the case of insects. Gauze netting spread over foods drying in the open may be necessary to keep insects out of storage or packing places. Careful cleaning and fumigation of the premises and equipment before a new crop is put into a storage space may save it from contamination by insects surviving from the previous crop. The use of infested secondhand bags is another common source of trouble.

While insecticides and fumigants have their function (for example, in preparing a storage space for spices or other foods), a product which is already infested is not made acceptable for food by fumigation. Insects are objectionable in food even though they may have been killed. Most insecticides and fumigants are poisonous; and if they contaminate food, the food may become adulterated and may be subject to legal action. While most fumigants are volatile, they may nevertheless result in contamination of the food or adversely affect nutritive values. Legal tolerances for such residues have been issued (40 CFR 185).

In some cases, herbs may be used for drug purposes and they then become subject to the drug provisions of the Federal Food, Drug, and Cosmetic Act discussed in Chapter II. Those spices or spice oils which are in the United States Pharmacopeia or the National Formulary are subject to the standards set forth in these compendia when used for drug purposes.

Many herbs once thought to have medicinal value continue to be marketed for various purposes. If no therapeutic claims are made or implied in the labeling or other promotional material, such products are regarded as foods and subject only to the food provisions of the law. For example, the herb ginseng is permitted to be sold as a tea.

"Herbs" are not necessarily harmless, contrary to common belief. Many such plants are toxic and may be extremely dangerous. As required by law, the Food and Drug Administration will prevent the marketing of herbs, for medicinal purposes, if they have not been determined to be safe and effective for their intended uses.

Spices and herbs must be the genuine products indicated by their common names on the labels. If obtained from or mixed with material from other plants, they are both adulterated and misbranded. The identities of herbs and spices are established by their botanical names. For example, the herb labeled as "sage" is Salvia officinalis L. As a guide to the identities of food spice products, the Food and Drug Administration uses the following definitions: Spices-Aromatic vegetable substances used for the seasoning of food. They are true to name, and from them no portion of any volatile oil or other flavoring principle has been removed. Onions, garlic, and celery are regarded as foods, not spices, even if dried. The following list is not all inclusive:

• Allspice- The dried, nearly ripe fruit of Pimentia officinalis, Lindl.

• Anise- The dried fruit of Pimpinella anisum L.

• Bay Leaves- The dried leaves of Laurus nobilis L.

• Caraway Seed- The dried fruit of Carum carvi L.

• Cardamom- The dried, nearly ripe fruit of Elettaria cardamomum Maton.

• Cinnamon- The dried bark of cultivated varieties of Cinnamomum zeylanicum Nees or of C. cassia (L.) Blume, from which the outer layers may or may not have been removed.

• Ceylon Cinnamon- The dried inner bark of cultivated varieties of Cinnamomum zeylanicum Nees.

• Saigon Cinnamon, Cassia- The dried bark of cultivated varieties of Cinnamomum cassia (L.) Blume.

• Cloves- The dried flower buds of Caryophyllus aromaticus L.

• Coriander- The dried fruit of Coriandrum sativum L.

• Cumin Seed- The dried fruit of Cuminum cyminum L.

• Ginger- The washed and dried, or decorticated and dried, rhizome of Zingiber officinale Roscoe.

• Mace- The dried arillus of Myristica fragrans Houtt.

• Macassar Mace, Papua Mace- The dried arillus of Myristica argentea Warb.

• Marjoram, Leaf Marjoram- The dried leaves, with or without a small proportion of the flowering tops, of Majorana hortensis Moench.

• Nutmeg- The dried seed of Myristica fragrans Houtt, deprived of its testa, with or without a thin coating of lime (calcium oxide).

• Macassar Nutmeg, Papua Nutmeg, Male Nutmeg, Long Nutmeg- The dried seed of Myristica argentea Warb, deprived of its testa.

• Paprika- The dried, ripe fruit of Capsicum annuum L.

• Black Pepper- The dried, immature berry of Piper nigrum L.

• White Pepper- The dried, mature berry of Piper nigrum L.from which the outer coating or the outer and inner coatings have been removed.

• Saffron- The dried stigma of Crocus sativus L.

• Sage- The dried leaf of Salvia officinalis L.

• Tarragon- The dried leaves and flowering tops of Artemisia dracunculus L.

• Thyme- The dried leaves and flowering tops of Thymus vulgaris L.