7-OH Compliance Rules

Compliance rules for 7-OH (7-Hydroxymitragynine) products

Gabriela

Last Update 4 months ago

*Age gate at landing +21. If you work on WOOCommerce, our compliance plugin will manage this for you. Remember to disable third-party age gates and leave only the one provided by WAAVE´s compliance plugin.




*FDA disclaimer is mandatory and needs to be on the landing page for the store and on each product page.



*7-Hydroxymitragynine (7-OH) follows the same compliance rules as KRATOM; hence, it cannot be shipped to: ALABAMA, ARKANSAS, INDIANA, RHODE ISLAND, VERMONT, CONCORDIA PARISH LA, and WISCONSIN. SARASOTA COUNTY, UNION COUNTY, MALHEUR COUNTY, DENVER CO, SAN DIEGO CA, CITY OF OCEANSIDE CA, JERSEYVILLE IL, ALTON IL, EDWARDSVILLE IL, FRANKLIN LA, RAPIDES LA, PARKER AND MONUMENT (COLORADO), ASCENSION AND GRANT PARISH (LOUISIANA), FRANKLIN (NEW HAMPSHIRE). WASHINGTON D.C., AND SEVERAL COUNTIES IN MISSISSIPPI.


*Also, there is a 2% 7-OH limit in the following states: Arizona, Oklahoma, Texas, Utah.


*Tennessee and Georgia ban 7-OH as it is a processed/enhanced product.


*In addition, ID validation is also required in: Florida, Virginia, West Virginia, Colorado, Louisiana, Oregon, South Dakota


*If a product has 7-Hydroxymitragynine (7-OH) it cannot mention "kratom" on the product label.


*7-OH products cannot be labeled as "Dietary supplements".


*7-OH is a very controversial product, and there are serious compliance points to keep in mind as a merchant:


1. It cannot be classified as Kratom or advertised as Kratom

2. It cannot say it is "natural"

3. It cannot have a shocking name, for example “Roxy”

4. it cannot have an FDA warning letter against the brand product


*A Certificate of Analysis is mandatory

Only third-party kratom testing can confirm that 7-hydroxymitragynine extracts are free from residual chemicals and contain appropriate potency levels.


COA requirements:

1. Must not be older than 12 months

2. Must have the exact name of the item on it

3. Must be from an accredited lab

4. If there are multiple flavors multiple COAs are needed

5. If your company name is not on the COA please provide an invoice that links your company to the name of the company provided on the COA


‍6. COA must be for the end product, not the parts


7. COA must be displayed on the product page


*Shipping limitations must be displayed on the site. If on WOOCommerce, WAAVE´s Compliance plugin will manage your disclaimer and age gate for you.


Example disclaimer:

“Our products are not for use by or sale to individuals under the age of 21. The sale of products containing 7-hydroxymitragynine exceeding 2% of total alkaloid content is prohibited in Arizona, Oklahoma, Texas, and Utah. Additionally, 7-OH products are not shipped internationally;Tennessee and Georgia ban 7-OH as it is considered a processed product. State and Local Restrictions:7-hydroxymitragynine is banned in states and jurisdictions that prohibit kratom, including but not limited to: States: Alabama, Arkansas, Indiana, Rhode Island, Vermont, WisconsinCounties and Cities: Concordia Parish (LA), Sarasota County (FL), Union County (FL), Malheur County (OR), Denver (CO), San Diego (CA), City of Oceanside (CA), Jerseyville (IL), Alton (IL), Edwardsville (IL), Franklin (LA), Rapides (LA), Parker and Monument (CO), Ascension and Grant Parishes (LA), Franklin (NH), Newport Beach (CA), Washington D.C., and various counties in Mississippi. ID Verification: ID verification is required for shipments to the following states: Florida, Virginia, West Virginia, Colorado, Louisiana, Oregon, and South Dakota. Health and Safety Warnings: 7-hydroxymitragynine is NOT intended to diagnose, treat, cure, or prevent any disease, illness, or condition. Please consult your doctor before using any new products.This product contains chemicals, including nickel, arsenic, and lead, known to the State of California to cause cancer, birth defects, or other reproductive harm. For more information, visit www.p65warnings.ca.gov. Pregnant women should avoid use, as kratom has not been tested for safety in pregnancy. For FDA guidance, see FDA alert 54-15.Shipping Restrictions: Products cannot be shipped to military bases. Important Notes: This product is not classified as kratom and is not a natural product. It may contain synthetic or unknown chemicals. Use responsibly and in compliance with local regulations.”








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