Testing Requirements by Sales Channel

How do testing requirements compare across sales channels?

Testing expectations by sales channel, as of 3 November 2026. Sources: eCFR (21 CFR 101.9, Part 111, 117.165), Amazon’s US dietary supplements policy page in Seller Central, OEHHA, and CRS In Focus IF13136.

Channel	Who sets the rule	What is expected	Where to check
Any US dietary supplement	FDA, 21 CFR Part 111	Identity test of each dietary ingredient before use; finished batches, or a statistically sampled subset, verified against specifications; written lab procedures and records	eCFR, Part 111
Amazon, US dietary supplements	Amazon policy	Notified listings verified through an Amazon-authorized TIC provider; GMP audit evidence for the facility; for five supplement categories, heavy metal and microbial testing plus label tolerance and adulterant checks	Amazon Seller Central, Dietary supplements policy
Other retailers and distributors	The buyer	Tests, limits, frequency and lab rules written into the supplier agreement or vendor manual	Your buyer’s written requirements
Products sold to people in California	Proposition 65, administered by OEHHA	Clear and reasonable warning for listed chemicals unless exposure is at or below the safe harbor level; testing is how most brands estimate exposure	OEHHA
Hemp-derived cannabinoid products	Federal hemp definition (P.L. 119-37) and state law	Products with cannabinoids that cannot occur naturally fall outside hemp from 12 November 2026; from 11 December 2026, total THC, including THCA, of not more than 0.3 percent on a dry weight basis, and final products over 0.4 mg combined total THC and similar cannabinoids per container fall outside hemp	CRS IF13136; your state department of agriculture
Food and beverage	FDA, 21 CFR Part 117 and 101.9	Product testing as a verification activity where appropriate; nutrition label values judged on a composite of 12 subsamples	eCFR, 117.165 and 101.9(g)

Figures checked against the sources below on 3 November 2026; rules change, so confirm the current version before relying on them.

What does FDA require for every dietary supplement?

21 CFR Part 111 applies to anyone who manufactures, packages, labels or holds a dietary supplement, including products imported or offered for import (21 CFR 111.1). Its testing core: set specifications for components and finished batches (111.70), verify the identity of each dietary ingredient before use (111.75(a)(1)), verify finished batches against product specifications on every batch or a subset picked through a sound statistical sampling plan (111.75(c)), and use appropriate, scientifically valid methods (111.75(h)).

Part 111 does not require a seal or name a particular lab. Section-by-section detail is on 21 CFR 111 testing requirements.

What does Amazon require for dietary supplements?

From Amazon’s US dietary supplements policy page in Seller Central, read on 3 November 2026:

Amazon requires sellers to work with an authorized testing, inspection, and certification (TIC) provider to verify the listings Amazon has notified; the provider reviews existing documents or tests the product and submits the results to Amazon on the seller’s behalf.
Amazon requires the product to be made in a facility that meets 21 CFR 111 or 21 CFR 117, or equivalent, shown by a current GMP audit or certification from an accredited auditor; it does not accept private, first-party or consulting audits, or FDA inspections.
For supplements marketed for bodybuilding, joint health, sexual enhancement, sports nutrition or weight management, the policy adds testing for heavy metal and microbial contaminants, possible pesticide testing under NSF/ANSI 173-2024 or USP standards, dietary ingredients within the tolerances of 21 CFR 101.36 and 101.9(g)(3) and (g)(4), and testing for known adulterants listed in NSF/ANSI 173-2024.
Sellers can use other accredited labs, but Amazon requires their results to be validated by an authorized TIC provider.
Documents must be authentic, in their original unmodified format, and not computer or AI-generated.
Amazon requires a PCR test report from an ISO/IEC 17025-accredited laboratory, covering all high-risk ingredients, when a non-GMO claim is supported by lab testing.
The policy lists CBD among the controlled substances that supplements must not contain.

Amazon revises this policy, so read the current version in Seller Central before you order testing, then compare it with your existing CoAs to see what a TIC provider will still need.

What do other retailers and distributors require?

No public standard covers every retailer. Requirements usually arrive in a supplier agreement, vendor manual or quality questionnaire, and they differ by buyer and category. Get these points in writing before you test:

Tests and limits, with units and reporting basis.
Frequency: first lot only, every lot, or periodic checks.
Lab rules: some buyers require reports from ISO/IEC 17025-accredited labs or from labs on an approved list.
Document format: one CoA per lot, with report number, signature and lot number.
Retest triggers, such as a formula, supplier or manufacturer change.

What does Prop 65 mean for products sold in California?

According to OEHHA, which administers it, Proposition 65 requires businesses to provide clear and reasonable warnings before knowingly and intentionally exposing anyone to a listed chemical. The key facts for product sellers:

The list must be updated at least once a year, and businesses have 12 months after a chemical is listed to comply with the warning requirement.
Businesses with fewer than 10 employees are exempt, and so are exposures low enough to pose no significant risk.
Safe harbor levels guide that judgment: No Significant Risk Levels for carcinogens, set at no more than one excess cancer case in 100,000 people exposed over a 70-year lifetime, and Maximum Allowable Dose Levels for reproductive toxicants, set at the no observable effect level divided by 1,000.
The law does not order testing, but OEHHA notes that a business has the burden of proving a warning is not required.

What testing involves is covered in Prop 65 testing, and the element-by-element numbers in heavy metal limits.

What hemp rules apply to CBD and other hemp products?

The FY2026 Agriculture appropriations law (P.L. 119-37, Division B) amends the federal definition of hemp. According to CRS In Focus IF13136 (updated 28 September 2026), the new definition:

sets a total THC concentration, including THCA, of not more than 0.3 percent on a dry weight basis;
excludes hemp-derived cannabinoid products containing cannabinoids that are not capable of being naturally produced by the plant, or that are synthesized or manufactured outside the plant;
excludes intermediate products with more than 0.3 percent combined total THC and other cannabinoids with similar effects;
excludes final products with more than 0.4 milligrams combined total per container of total THC and other cannabinoids with similar effects.

Dates: the exclusion of cannabinoids that cannot occur naturally takes effect on 12 November 2026; the other portions were delayed to 11 December 2026 by P.L. 119-103. Bills to delay the definition by two more years (H.R. 7024, H.R. 7010, S. 3686) or repeal the changes to the definition (H.R. 6209) are pending, and as of 28 September 2026 FDA had not yet published the cannabinoid lists the law requires. Re-check before relying on any of this.

States set their own product rules on separate schedules; your state department of agriculture or hemp program is the authority there, and the USDA hemp program covers production plans. Because the per-container line is so low, the LOQ of a potency method matters; how to read a CoA works through the calculation.

What testing do food and beverage products need?

Under the preventive controls rule, product testing for a pathogen, an appropriate indicator organism or another hazard is a verification activity used as appropriate to the facility, the food and the control (21 CFR 117.165(a)(2)). Labeling has firmer numbers. FDA judges Nutrition Facts values on a composite of 12 subsamples, one from each of 12 randomly chosen shipping cases (21 CFR 101.9(g)(2)), and:

added (Class I) vitamins, minerals, protein and dietary fiber must be at least equal to the declared value;
naturally occurring (Class II) nutrients must be at least 80 percent of the declared value;
calories, total sugars, total fat, saturated fat, trans fat, cholesterol and sodium, and added sugars where all sugars are added, must not exceed the declared value by more than 20 percent.

More on lab-based label values is on nutritional analysis. Compare your current CoAs with the table at the top of this page to see which channel’s expectation you have not yet covered.

Figures checked against the sources below on 3 November 2026; rules change, so confirm the current version before relying on them.

Questions about this page

If a product meets 21 CFR 111, is it ready for Amazon?

Not necessarily. Amazon's policy asks for documents verified through an authorized TIC provider, GMP audit evidence for the facility, and for certain supplement categories, contaminant, label tolerance and adulterant testing. Meeting Part 111 is the starting point, while the documents Amazon wants are an added layer that has to be checked against its current policy.

Do online sellers outside California need to think about Prop 65?

Prop 65 is about exposures to people in California, so a product shipped to California customers can be covered even if the seller is based elsewhere. Businesses with fewer than 10 employees are exempt from the warning requirement. Retailers may also ask suppliers to state whether a product needs a Prop 65 warning.

Which requirement should a multi-channel brand test to?

Test to the strictest applicable requirement for each analyte, so one CoA per lot works everywhere. In practice that means listing every channel's tests, limits, reporting basis and lab rules side by side, taking the tightest of each, and writing that into your own product specification.

Do state hemp rules replace the federal definition?

No. The federal definition sets what counts as hemp nationally, and states can add their own rules for products sold within their borders, such as testing panels, labeling and age limits. A product can meet the federal definition and still fall short of a state rule, so check both before you sell into a new state.

Does Part 111 apply to food products sold alongside supplements?

No. Part 111 covers dietary supplements. Conventional foods and beverages fall under 21 CFR Part 117 and the food labeling rules in Part 101. A product's classification depends on how it is labeled and marketed, so a drink sold as a supplement and one sold as a beverage face different rules.

Sources: 21 CFR Part 111, dietary supplement CGMP rule (eCFR) · 21 CFR 117.165, Verification of implementation and effectiveness (eCFR) · 21 CFR 101.9, Nutrition labeling of food (eCFR) · OEHHA, Proposition 65 in plain language · CRS In Focus IF13136, Changes to the Statutory Definition of Hemp (updated 28 September 2026) · USDA AMS, Hemp production program
Last reviewed: 3 November 2026