CRITICALNutrition / SupplementsFDA Warning Letter · July 29, 2022

Deggeh Foods, Inc.

Atlas ID: 2022-07-fda-deggeh-foods-inc-tawsm4

FDA issued a warning letter to Deggeh Foods, Inc. (Bronx, NY) after inspecting their facility and reviewing their website and Facebook page, finding that four products — Actibest® Health Plus Capsules, Best Hemorrhoids Rapid Action Herbal Healing Formula, StomachAID capsules, and Moringa Tea Bags — bore disease-treatment and cure claims that rendered them unapproved new drugs under the FD&C Act. The products were also found to be adulterated dietary supplements due to multiple CGMP violations, and misbranded due to extensive labeling deficiencies. FDA demanded a written response within 15 working days and warned that failure to comply may result in seizure or injunction.

Flagged claims (11)

Actibest…Fast, Instant relief for: •Diabetes •Blood Pressure…•Hepatitis •Arthritis…•Constipation…•Hemorrhoids…•Migraines…•Cancer •Insomnia •Stroke • Asthma…•Acid Reflux…•Kidney Problems…•Joints, Back Pain

Cure claim · unapproved-new-drug-disease-claim

Best Hemorrhoids Rapid Action Herbal Healing Formula

Cure claim · unapproved-new-drug-disease-claim

15 Times The Potassium Bananas

Comparative claim w/o evidence · relative-nutrient-claim-missing-quantitative-data

17 Times the Calcium in Milk

Comparative claim w/o evidence · relative-nutrient-claim-missing-quantitative-data

Prevention and Relief for Gastric Ulcers, Acid Reflux . . . Indigestion . . . Food Poisoning Stomach Worms & Parasites

Cure claim · unapproved-new-drug-disease-claim

12 Times the Vitamin C in Oranges

Comparative claim w/o evidence · relative-nutrient-claim-missing-quantitative-data

25 Times The Iron In Spinach

Comparative claim w/o evidence · relative-nutrient-claim-missing-quantitative-data

4 Times The Vitamin A In Carrots

Comparative claim w/o evidence · relative-nutrient-claim-missing-quantitative-data

Instant Relief Fortified Herbal Formula for High Blood, Cholesterol, Asthma, Cancer Arthritis, Depression, Migrains [sic], Sickle Cell Kidney Problems Liver Problems . . . Diabetes, Rheumatism, Insomnia, Circulation Problems Hermoroids [sic], Acid reflux, Gastric Ulcers

Cure claim · unapproved-new-drug-disease-claim

SOOTHING MORINGA TEA . . . HELPS PREVENT CANCER, DESTROYS EARLY CANCEROUS CELLS

Cure claim · unapproved-new-drug-disease-claim

Get almost instant results and relief for: MIGRAINS [sic], HIGHBLOOD [sic] PRESSURE, HIGH SUGAR, DIABETES, HIGH CHOLESTEROL . . . INSOMNIA . . . SICKLE CELL, ASTHMA, RHEUMATISM, ARTHRITIS, LIVER AND KIDNEY DISEASE.

Cure claim · unapproved-new-drug-disease-claim

Required actions (2)

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.

Response required · 15 days

Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Injunction

Source

www.fda.gov · FDA Warning Letter

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