The increasing prevalence of allergic diseases in westernized countries poses a significant health problem and a tremendous burden on quality of life and healthcare expenditure. Food allergy affects as many as 6% of young children and 3% to 4% of adults. While the majority of children outgrow their allergy to milk, egg, wheat and soy, allergies to peanut, tree nuts, fish and shellfish are often life-long. Currently, there are no treatments that can cure or provide long-term remission from food allergy. Based on our preliminary studies, we hypothesize that our investigational botanical drug, FAHF-2TM, will be a safe and effective herbal therapy for food allergy.

To address our hypothesis, we propose the following aims:

Aim #1: To investigate the safety of FAHF-2TM for food allergy (in addition to current food allergen avoidance).

Aim #2: To characterize the immunomodulatory effects of FAHF-2TM on food allergic patients

Inclusion Criteria:

• Male and female subjects ages 12 through 45 years of age and otherwise in good health as determined by medical history and physical examination
• History of allergy to peanut, tree nut, fish or shellfish as documented by a positive skin test and/or food allergen-specific IgE level [skin prick test positive (end-point prick skin test titration performed in duplicate, one in each arm; mean wheal diameter >5 mm greater than mean of saline control; peanut, tree nut, fish or shellfish specific IgE > 0.7 kU/L)
• The subject agrees to participate in the study or the subject's parent or legal guardian is willing and able to give written informed consent, and the pediatric subject gives assent for participation in the study.
• Females of childbearing potential must be inactive sexually or take effective birth control measures, as deemed appropriate by the investigator, for the duration of the study

Exclusion Criteria:

• Acute febrile illness (such as cold, flu, etc.) within one week before administration of study drug
• Any history of systemic disease that in the investigator's opinion would preclude the subject from participating in this study, e.g. autoimmune disease, neoplasms, HIV or hepatitis virus infection
• Abnormal hepatic function (ALT/AST and bilirubin >1.25 x upper limit of normal)
• Abnormal bone marrow function (WBC <4 x 103/mm3; platelets <100 x 103/mm3; hgb <11 g/dl)
• Abnormal renal function (BUN and creatinine >1.25 x upper limit of normal)
• Clinically significant abnormal electrocardiogram
• Current uncontrolled moderate to severe asthma with FEV1 <80% predicted
• Participation in another experimental therapy study within 30 days of this study
• History of alcohol or drug abuse
• Currently taking antidepressant medication
• Pregnant or lactating female subjects. Females of childbearing potential will need a negative serum pregnancy test at screening to be considered for this study