Notice Number: NOT-OD-19-145
Key Dates
Release Date: September 16, 2019
PA-18-817
Issued by
Office of Dietary Supplements (ODS)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Environmental Health Sciences (NIEHS)
Fogarty International Center (FIC)
National Center for Complementary and Integrative Health (NCCIH)
Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)
National Cancer Institute (NCI)
Purpose
This Notice clarifies the documentary evidence on the composition and identity of materials that should be provided for the product integrity evaluation in PA-18-817 "Administrative Supplements for Research on Dietary Supplements"
Section IV- Application and Submission Information; Section 2. Content and Form of Application Submission
Currently reads:
Product Integrity Information (Uploaded via the Other Attachments Section for electronic submissions): To ensure reproducibility of the research, dietary supplements must be rigorously identified, characterized, and documented.
- For botanicals, the complete taxonomic/scientific name along with the common name and source of the plant material/extract/phytochemical.
- Identify the manufacturer or distributor (if any) by name and address and contact information along with product brand name, if applicable.
- State the constituent(s), if any, to which the product is standardized.
- For non-botanical ingredients a full description is required. This should include brand name (if given), chemical purity (and methodology determined), and isomeric purity. Lot specific or batch specific certificates of analysis from the manufacturer are acceptable.
- Characterize the supplement composition (ingredient content and quantity), including laboratory analysis to confirm information on the certificate of analysis, if applicable.
- Provide documentation that demonstrates stability of ingredients for at least the duration of the study and explain how the product will be monitored for stability throughout the project period.
- Provide documentation that demonstrates reproducibility of product characteristics, especially if more than one batch is used in the study.
- Assure that the product is free of impurities (accidental or deliberate), e.g., pesticides, drugs, microbes, or metals.
- If the product is administered via a vehicle other than a tablet/capsule, provide information on the source and composition of the vehicle (diet, etc.) and assure that the ingredient or intervention remain stable and bioavailable (e.g., probiotic added to porridge, EGCG added to rat food) throughout the study.
- For placebo, verify that the product matches the test agent on sensory characteristics, that the sensory characteristics are stable, and that the product contains no bioactive materials.
Should read:
Product Integrity Information (Uploaded via the Other Attachments Section for electronic submissions): To ensure reproducibility of the research, dietary supplements must be rigorously identified, characterized, and documented.
1. Establish the identity, composition, and purity of the test article(s) (dietary supplement that is being investigated and appropriate controls). Manufacturer provided lot- or batch-specific certificates of analysis (CoAs), with quantitative analytical results, may be acceptable; product specification sheets and safety data sheets are NOT adequate.
a. Characterize the test article composition, including ingredient content and quantity, and report results of the laboratory analysis to confirm information on the certificate of analysis, if applicable.
b. For complex test article(s) derived from living organisms, the complete taxonomic/scientific name along with the common name and source of the plant/animal material/extract/phytochemical.
c. For all test articles, provide documentation demonstrating both chemical and isomeric purity (when appropriate), including the methodology used in purity determination.
d. State the constituent(s), if any, to which the test article is standardized.
e. Assure test article(s) is/are free of impurities (accidental or deliberate), e.g., pesticides, drugs, microbes, or metals.
f. Identify the manufacturer or distributor (if any) by name and address and contact information along with product brand name, if applicable.
2. Establish stability and reproducibility of the test article preparation.
a. Provide documentation that demonstrates stability of test article(s) for at least the duration of the study and explain how the test article(s) will be monitored for stability throughout the project period.
b. Provide documentation that demonstrates reproducibility of test article(s) characteristics, especially if more than one batch is used in the study.
3. If the test article is administered via a vehicle other than a tablet/capsule, provide information on the source and composition of the vehicle (e.g. diet) and assure that the test article(s) remain stable and bioavailable (e.g., probiotic added to porridge, a botanical added to animal diet) throughout the study.
4. For placebo, verify that it matches the test article on sensory characteristics, that the sensory characteristics are stable, and that it contains no bioactive materials.
Inquiries
Please direct all inquiries to:
Cindy Davis
Office of Dietary Supplements (ODS)
Telephone: 301-496-0168
Email: davisci@mail.nih.gov
and Human Services (HHS)
