Attachment 1 Statement of Work.docx

Statement of Work

The Dietary Supplement Ingredient Database: Monitoring Ingredient Levels and Performance Quality of Dietary Supplements on the U.S. Market

Why Are These Laboratory Contracts Critical to the USDA’s mission?

The USDA’s Dietary Supplement Ingredient Database (DSID), an interagency partnership with the NIH Office of Dietary Supplements (NIH ODS), is an initiative that provides critical ingredient estimates for commonly consumed dietary supplements (DS). To provide these estimates, USDA contracts with laboratories with specialized expertise, advanced analytical technologies, and rigorous quality control measures to determine ingredient content and performance quality of various DS dosage forms. Their analyses ensure national estimates reflect actual ingredient levels in DS dosage forms rather than relying solely on label claims, and the statistical results inform national nutrition monitoring programs (most notably, the National Health and Nutrition Examination Survey and What We Eat in America). These contracts are essential to the overall DSID objectives of the interagency agreement and must continue. Testing projects are underway that will continue into the next fiscal years.

The DSID, and its associated contracts, align with key legislative frameworks, including the Farm Bill, which addresses hunger, malnutrition, and sustainable food systems, and the Dietary Supplement Health and Education Act (Public Law 103-417, DSHEA). Under DSHEA, DS are classified as foods, not pharmaceuticals, requiring independent analytical verification of their content and the quality of the dosage forms. These contracts help meet legislative priorities by delivering transparent, science-based assessments of DS composition for consumers and researchers.

The DSID involves a wide range of federal partners beyond the USDA and NIH ODS, including the NIH National Cancer Institute, National Center for Complimentary and Integrative Health; Food and Drug Administration; Center for Disease Control and Prevention, National Center for Health Statistics; Department of Defense; and the Department of Commerce all contribute to DSID. These agencies guide the DSID’s direction and rely on its data for research, policy development, and public health decisions.

Significant gaps remain in understanding the true ingredient levels and bioavailability (how well the body absorbs nutrients) of dietary supplements in the US market. Label claims often do not match actual ingredient levels, which can mislead consumers and affect nutrition research. Without continued lab support, the DSID’s ability to generate high quality, independent data would be compromised, weakening federal nutrition programs and public health efforts. The continuation of these contracts is essential to safeguarding the integrity and utility of DSID research and understanding the consumer health impacts of dietary supplements.

I. Background Information and Objectives

A. Background Information

The United States Department of Agriculture (USDA) Method and Application of Food Composition Laboratory (MAFCL) collaborates with the National Institutes of Health (NIH) Office of Dietary Supplements (ODS) and other federal partners to develop, maintain, and expand the analytically based Dietary Supplement Ingredient Database (DSID). Funded by NIH-ODS, this project is guided by a DSID Federal Working Group that convenes monthly. Scientists on the DSID team evaluate analytical results for ingredients in commonly consumed dietary supplements (DS) and generate statistically derived national estimates of means and variability at specific labeled levels. These estimates adjust label-provided ingredient content to enhance the accuracy of intake calculations from DS consumption. Combined with nutrient intakes from food, DSID data improve total dietary intake estimates which evaluate the impacts of food and DS on health. DSID data are publicly accessible at: https://dsid.usda.nih.gov.

Additionally, the MAFCL DS team investigates the performance quality of oral dosage forms (capsules and tablets) for botanical and nutrient-based DS. Beyond ingredient content, a supplement’s efficacy depends on its ability to disintegrate and release nutrients, a critical step affecting bioavailability and therapeutic effectiveness.

For the DSID project, MAFCL relies on contracts with commercial laboratories to test DS for ingredient content and dosage form quality.

B. Objectives

With this Statement of Work (SOW), MAFCL aims to partner with laboratories to gather accurate analytical data on the ingredients in DS and their quality. These data will be obtained through physical tests and chemical assays by laboratories using valid, up-to-date analytical methodology and rigorous quality control (QC) programs based on the use of Certified Reference Materials (CRMs), other in-house QC materials and thorough documentation.

II. Services to be Performed

A. General Requirements

The Contractor will test DS samples sent by MAFCL or its designee, following the tests and ingredient analyses listed in Attachment A. If additional tests or ingredient analyses are needed, the Contract will be updated to include them and the Contractor may be required to demonstrate expertise by submitting methods, validation information and control charts.

B. Specific Tasks/Technical Requirements

Task 1. Ingredient Analyses and Tests

Weighing, Homogenization and Extraction of Dietary Supplement samples

Dietary supplement samples will arrive in the form in which they are sold (e.g., tablets, softgels, capsules, powders, chewable tablets, gummies, soft chews, liquids) and may contain various ingredients. All pill forms, including gummies or unusual forms will need to be weighed using an analytical balance that displays readings with 4 decimal places (e.g., 0.0001 grams). Afterwards, they will be ground, and/or blended (homogenized) based on their form. The following procedures are required:

· For tablets and capsules, weigh a set number of units before blending (grinding/homogenization), and for capsules and softgels, also weigh the empty shells after cleaning and drying.

· Report all weights, blending methods, and times with test results.

· For liquids, measure specific gravity (a way to determine density).

Some samples may need extra steps, like moisture testing or special grinding (such as cryogenic grinding) for labile ingredients (e.g. folic acid, vitamin C, beta-carotene and other carotenoids). Unique methods may be required for DS with microencapsulated ingredients or liquid mixtures (emulsions/suspensions). Unless otherwise agreed, we require homogenization of at least 20 tablets/capsules/units, per the United States Pharmacopeia (USP) standard requirements for DS testing.

1.1 Primary Ingredient Analyses and Tests

The Contractor will periodically (usually once per year) receive Task Orders listing the quantity of specific tests or ingredients (as awarded in the Contract) expected to be tested in that fiscal year, with samples sent in batches of 20-30. These batches will include blinded quality control samples (e.g., certified reference materials, inhouse control materials and duplicate samples) to check the lab’s accuracy and precision.

· MAFCL will notify the Contractor at least one week before shipping samples.

· Batches may come in groups, (e.g., 5-6 batches; 75-120 samples in a month), with gaps of 2-3 months without shipments.

· The samples in each batch may require testing for multiple ingredients (over 20 for multivitamins). Samples will be mostly finished products, but sometimes raw materials will be tested.

Instructions will be provided in a cover letter for each set of samples, which will be emailed to the Contractor and included as a hardcopy with the samples. Additional sample information and instructions will be provided in excel spreadsheets emailed along with the cover letter. MAFCL expects these instructions to be followed. If the Contractor has any questions about the instructions, they should request clarification before testing the samples.

Upon arrival, the Contractor must check samples for condition and quantity, notifying MAFCL immediately of any issues. Next:

· Store samples as instructed for that group of samples (e.g., from -60°C to room temperature). Most samples will require a weighing step and a homogenization step.

· Homogenize all pills/units sent.

· After homogenization, store samples at -60°C unless testing right away or instructed otherwise.

· Handle samples carefully to maintain sample integrity for the ingredient content, and to ensure homogeneity of aliquots used for analysis of specific ingredients. If special handling is required by MAFCL, instructions will be sent with the samples. Specific handling designated in the Contractor’s SOP should be documented.

· Test samples for ingredient content and dosage performance quality as specified in the instructions. Vitamins and other sensitive ingredients must be tested within one day after preparing the homogenate.

It is important to note that for chemical assays, the DS studies at MAFCL require at least 20 tablets/capsules to be homogenized. Aliquots from this homogenate should be used for the assays. If the DS to be tested are quite large (e.g., soft chews >5 g each), MAFCL may accept homogenization of <20 sample units.

The laboratory shall use methods approved by the Association of Official Analytical Chemists (AOAC, International), the United States Pharmacopeia (USP), or equivalent methods, including in-house methods which have been validated in your facility. Document any changes to the standard analytical methods and share full details with MAFCL. Non-AOAC/USP methods must be fully described. Method details adequate for evaluation, reporting and publication must be shared with MAFCL scientists. If using USP methods, the contractor must have a USP subscription for the latest USP monographs and general chapter information. The USP methods used must be the most recent published protocols, unless MAFCL and the Contractor agree to use a prior version.

Unique homogenization procedures may be required for certain labile ingredients (e.g. folic acid, vitamin C, beta-carotene and other carotenoids). Special homogenization or extraction procedures may be required for DS with microencapsulated components or liquid emulsions/suspensions.

The Contractor must apply appropriate quality control procedures during DS sample analyses. Report the results of QC analyses to MAFCL in the units and number of significant digits specified in Attachment A.

If during the Contract period, the Contractor wishes to change a method specified in their proposal, they may do so after providing validation for the new or modified method and after acceptance by the Contracting Officer's Representative (COR).

The remainder of the homogenized samples shall be stored at -60° C (or as specified) until the results are approved and the study is completed. The Contractor must get permission from the MAFCL laboratory liaison to discard any stored test samples.

1.2 Repeat Analyses and Tests

If MAFCL has questions about the test and assay results received, the Contractor will be contacted by email or phone. A conference call may be requested with the Contractor to review the results for MAFCL's quality control samples, the Contractor's provided QC information, the sample results, or to discuss in detail questions about sample handling, homogenization, extraction and testing.

It is likely that some samples will require retesting (repeat analyses or tests).

A. If retesting is required because of a failure by the Contractor to follow instructions for sampling handling (e.g., storage temperature or number of units to be homogenized) or to follow procedures for published methods, the additional costs will be the Contractor's responsibility.

B. If retesting is required due to errors in dilution or calculations by the Contractor, the additional costs will be the Contractor's responsibility.

C. If retesting is needed to verify unusual results (e.g., 80% above or below label claims, or results atypical of most samples), MAFCL will be responsible for the additional testing costs.

Sample retests are handled in one of two ways:

· An additional 20 units of the sample (or appropriate weight of liquids or powders) will be sent with a new test sample ID.

· Frozen homogenates of the original samples stored by the Contractor may be used for retesting.

The Contractor shall have 30 days to respond to a request to repeat any tests or analyses and to resolve any questions.

The remainder of the homogenized samples shall be stored at -60° C (or as specified) until the results are approved and the study is completed. The Contractor must get the permission from the DS laboratory liaison to discard any stored test samples.

Task 2. Reporting Requirements

The Contractor shall prepare reports as specified below. With each batch of samples sent, a reporting sheet (in excel format) is also sent. The Contractor is required to fill in the sheet with the sample results and other required documentation and email it to MAFCL.

2.1 Monthly Tracking Reports

In lieu of formal monthly reports, a tracking sheet is due once a month. The report shall be sent by email to the MAFCL laboratory liaison and shall contain, for each Task Order:

· List of batches received and awaiting analysis, along with expected dates of completion

· List of batches with completed analyses and the date completed (a cumulative listing)

· Additional relevant information

2.2 Data Files Results

Submit data files in our lab sheet reporting format. Report on the results of analyses within 30 days of receiving each batch of samples, including:

· A list of samples included in the data submission

· Detailed descriptions of sample processing, including any special procedures

· Methods of analysis, including any modifications

· The results of internal quality control procedures conducted at the same time as the analyses of the submitted samples

· Results for all analyses requested in the units and the number of decimal places specified in Attachment A of the SOW

· All sample weights and other sample information

· Sample density, if a liquid sample

· For DS physical testing, information about the appearance of the dosage forms is required, along with visual documentation (photographs) of dosage form and medium appearances at designated time points

· Indication if value is less than the LOD/LOQ and a listing of these quantities

Any change in data format submissions shall be clearly defined and agreed upon by MAFCL.

The e-mail files shall not contain any copy-protection coding or formatting which would prevent the government from making additional copies of the files.

THE DATA GENERATED BECOMES THE PROPERTY OF USDA AND SHALL NOT BE DISSEMINATED OR USED IN ANY OTHER WAY BY THE CONTRACTOR WITHOUT PERMISSION.

2.3 Problem Resolution Report

If there’s an issue with a method or laboratory performance, submit a report showing resolution of the problem within 10 business days of MAFCL’s communication about the issue. Explain the problem and how it was resolved.

Conclusion

This SOW ensures the DSID delivers reliable data on DS, supporting consumer safety, nutrition research, and public health policies. The Contractor’s role is critical to achieving these goals.