FDA Approval of Alternative Medicines, Dietary Supplements, Herbal Remedies for US Market
Consulting for US FDA requirements of supplements (herbal, dietary and food supplements), botanical drugs, Chinese Traditional Medicines, homeopathic medicines, health foods and various natural products. NDA, NAC and IND consulting for companies in China, India Southeast Asia and Europe.
- Botanicals: Botanical products are drugs based on plants including on vegetable, algae, bark, wood, leaves, stems, roots, flowers, fruits and seeds. Botanical medicine may include natural product extracts and medicinal plants.
- Dietary Supplements: Dietary Supplement products are intended to supply nutrients to the body. These may include nutritional products, nutraceuticals (i.e., “nutrition-pharmaceutical” products or “functional foods”), vitamins, minerals, etc.
- Traditional Medicines: Traditional Medicines consist mainly of Chinese Traditional Medicines (TCM) and Chinese Herbal Medicine (CHM). Also includes and complimentary medicines, therapeutic agents, alternative and holistic healing treatments, homeopathic medicine and herbs and herbal remedies/medicines, Traditional Indian Medicine (TIM, Ayurveda) and some pharmaceutical products licensed in China and other Asian countries. These products are typically ingested in powder, tablet, or capsule form and may include some experimental medicines.
Consulting Services for FDA Approval of Botanicals, Supplements and Alternative Medicines
- Consulting for Food, Cosmetics, Medical Device and Pharmaceutical Industries
- US Agent, Official Correspondent, FDA Registration
- International Import/Export of Chinese, Indian and other Asian herbal products into the United States
- Foreign traditional medicine and pharmaceutical industry company consulting for US FDA approval of products Health Foods (Functional foods), Dietary Supplements (Vitamins, minerals, herbal medicines and other products that improve bodily functions) and Drugs (NDA – New Drug Applications, NDC – National Drug Code, USP Classification)
- Safety and toxicity / toxicology studies: In-Vitro and In-Vivo toxicity
- Clinical trials / safety and effectiveness
- Chinese Regulatory matters including China GAP, China GMP and China SDA (State Drug Administration) Guidelines
- Health Claims for labeling and packaging
- Patent protection and licensing laws
Where to find Useful Information
United States Food and Drug Administration
- US FDA-CFSAN – Center for Food Safety and Applied Nutrition
- FDA-Food Labeling and Nutrition Information
- FDA-ONPLDS – Office of Nutritional Products, Labeling, and Dietary Supplements
- FDA-Division of Dietary Supplements
- FDA-Guidance Documents for Botanical Drug Products
US Department of Health and Human Services (HHS) and National Institutes of Health (NIH)
- Dietary Supplements
- NIH OAM Office of Alternative Medicine
- NIH Office of Dietary Supplements (ODS)
- NIH National Center for Complementary and Alternative Medicine (NCCAM)
Natural Products Associations