LegitScript CBD Product Certification Standards
Show the highest level of credibility when it comes to CBD product standards and business operations.
1. Relationship of Applicant to Product
The applicant must have substantial control over the manufacture, formulation, and labeling of the product and should be able to demonstrate compliance with all other standards. Eligible applicants include (1) product manufacturers, including contract manufacturers; and (2) entities selling products, under their own names, that are manufactured by a contract manufacturer, and who are otherwise able to demonstrate the product’s compliance with all other standards.
2. Licensure, Registration, Legal Compliance
a. The applicant must be duly registered as a corporate entity or legal person (e.g., as a limited liability company) in the state or jurisdiction where it appears to conduct business.
b. To the extent that licensure or registration is required in any jurisdiction where the applicant operates or provides services, the applicant must comply with such requirements. This may include the jurisdiction(s) from which the products are sold and any jurisdiction(s) to which the products are offered to be shipped.
3. Acceptable Products
Only products that are compliant with federal and state regulations may be certified.
Specific requirements include but are not limited to the following:
a. Foods and dietary supplements. Among other requirements, existing FDA guidance states that CBD may not be used in food or dietary supplements. Accordingly, at this time, food or dietary supplements containing CBD are not eligible for certification. Currently acceptable products may include, and are not necessarily limited to, the following, presuming compliance with other standards and requirements herein:
- topical products
- “bath bombs”
- whole hemp flowers
b. Products containing marijuana-derived CBD. Products containing CBD derived from marijuana, as defined in the US Controlled Substances Act, are ineligible for certification.
c. Cosmetics. If the product(s) the applicant seeks to certify are cosmetics, the applicant and applicable product(s) must be registered with the FDA’s Voluntary Cosmetic Registration Program.
4. Product Labeling and Marketing
All product labeling must conform to federal and state legal and regulatory requirements. For example, cosmetic products containing CBD must be labelled in compliance with FDA cosmetics regulations. Products may not be marketed with impermissible therapeutic claims, or, as LegitScript may determine in our sole discretion, marketed in an obvious attempt to circumvent applicable regulations.
5. Supply Chain / Test Results
a. The applicant must disclose its supply chain for all products, adhere to all supply chain-related regulatory requirements, and demonstrate a commitment to good manufacturing practices.
b. Additionally, the applicant must provide a testing facility approved by LegitScript, unexpired, random samples of products submitted for certification for testing. Such products must contain the advertised amount of hemp-derived compounds and must comply with legal requirements related to cannabinoid substances and ingredient levels.
c. The applicant must demonstrate that products submitted for certification were produced in compliance with all USDA and state hemp-cultivation requirements, or are otherwise exempt from such requirements.
6. Controlled Substances
Applicant may not manufacture or sell, in the United States, Schedule I controlled substances, as defined in the US Controlled Substances Act, including marijuana, except to the extent permitted by federal law. Applicant may also not manufacture or sell products containing ingredients that LegitScript has classified as global red flags.
The applicant’s business must not engage in practices or extend offers that may deceive or defraud regulators, customers, or the public in any way, including but not limited to any material detail regarding legal compliance and product marketing. Failure to provide full and accurate information as requested, in LegitScript’s sole discretion, will result in denial. Applicants may undertake reasonable remedial action during the certification process without penalty; provided, however, that a history of fraudulent behavior or non-transparent operations may, in LegitScript’s sole discretion, result in denial of the application.
8. Prior Discipline
The applicant, including any associated business or websites, must not have been subject to significant recent and/or repeated instances of improper legal compliance, disciplinary sanctions, or other regulatory action.
9. On-Site Inspections
You agree that LegitScript may conduct on-site inspections of your facility/ies, and you will in no way restrict LegitScript access.
10. Background and History
Applicant’s corporate officers, directors, or those exercising control over significant business decisions must submit to criminal background checks conducted at LegitScript’s request, and must disclose any prior criminal, regulatory, or civil violations. Applicant must also disclose any litigation commenced, resolved or otherwise addressed that involves applicant at any time over the past 10 years. Prior offenses or other bad acts, including any prior regulatory discipline may be a disqualifying factor, in LegitScript’s sole discretion.
Applicant must maintain and provide proof of general liability insurance.