VAPETASIA

compliance

VAPETASIA

compliance

VAPETASIA

compliance

Compliance with Federal, State and Local Laws 

All Company distributors and retailers are obligated to maintain compliance with all applicable Federal, State and Local laws and regulations, as applicable, including:  

  • The Federal Food, Drug and Cosmetic Act (FDCA), as amended by the Family Smoking Prevention and Tobacco Control Act – see below 
  • State and Local Health Codes 
  • State and Local Licensing and Tax Programs  
  • State and Local Laws and Regulations Applicable to Distribution of the Company’s Products, including state laws regarding state minimum purchase age for vapor products and delivery sales requirements (see Attachment I), California’s Stop Tobacco Access to Kids Enforcement Act (STAKE Act), and California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65)  

 All distributors must:   

  1. Enter into a written agreement with the Company to do business, which shall include an indemnification provision negotiated by the parties. To the extent that the Company has established business relationships with existing distributors, the Company will provide a shortened version of these guidelines to the those distributors with a future purchase order, as well as a website link to these full Guidelines, to put them on notice of the Company’s positions.
  2. Sell only to people who are old enough (at least 21 years old throughout the United States, confirmed using valid ID for any face-to-face transactions with consumers. If sales are made online, use adequate age-verification technology to prevent underage access to the website and to prevent underage sales through the Internet.  Age-verification technology should include independent, third-party age- and identity-verification services that compare customer information against third-party data sources.  The consumer’s age should be verified using reputable age-verification software such as AgeMatch (Veratad), Agechecker.net or BluecheckFor sales made to California residents, follow heightened online age verification requirements as provided in California’s Stop Tobacco Access to Kids Enforcement Act (STAKE Act). Ensure compliance with state laws on the minimum purchase age for vapor products and delivery sales requirements as provided in Attachment I. 
  3. If sales of flavored, cartridge-based ENDS products are made online, such sales must include a limit on the quantity of such flavored ENDS products (other than tobacco and menthol ENDS products) that a customer may purchase within a given period of time. This limit should correspond to the amount an individual can reasonably consume within the specified time period.  
  4. Not sell e-cigarettes or other ENDS in a vending machine unless in an adult-only facility.
  5. Not sell flavored ENDS products (except tobacco-flavored, and menthol-flavored ) to downstream online or brick-and-mortar retailers that have sold to minors – as indicated by FDA’s searchable retailer inspection database. 
  6. Not give out free samples to individual consumers.  
  7. Not bundle the Company’s product with e-liquids without the Company’s express permission.
  8. Not bundle the Company’s products with any food, beverage, drug or other consumable products. 
  9. Only provide samples to businesses in quantities sufficient to advance a business purpose and only with written assurances from the recipient that the product will be used for business purposes and not further distributed or sold.
  10. Not modify any Company labels or advertising without express written permission. 
  11. Agree to abide by all FDA and state law requirements regarding advertising and marketing of tobacco products, and indemnify and hold harmless Company for any violations of such laws. For example, provide the required nicotine warning statement in all advertising, including online advertising. For sales made to California residents, ensure compliance with any applicable California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) product packaging and website warning requirements.
  12. Agree not to market the Company’s products for anything other than recreational adult vaping or as directed by the Company (i.e., no “offlabel” uses).
  13. Ensure that it does not make, allow others within its control to make, or publicize or publish or distribute, any marketing materials, statements or claims, including but not limited to product review videos and articles (regardless of online or offline), without prior written authorization by Company regarding Company’s productsIf prior written authorization is received, any such marketing, including endorsements by social media influencers, must include necessary and appropriate disclosures about the health risks of nicotine, and any material connection must be clearly and conspicuously disclosed in such endorsements.
  14. Obtain appropriate product liability and other insurance and include Company as an additional insured when applicable.
  15. Not make any health or therapeutic claims, including smoking cessation claims, about the Company’s products.
  16. Not make any claims that the Company’s products: (i) present a lower risk of disease or is less harmful than another tobacco product; or (ii) contain a reduced level of, or is free from, a substance, or that exposure to a substance is reduced or eliminated.
  17. Require down-stream distributors and retailers, if any, to comply with above requirements by establishing and enforcing contractual penalties for such contracted parties.
  18. Distributors are responsible for adherence to all other FDCA requirements and this non-exhaustive list may be modified from time-to-time to aid distributors in identifying obligations under the FDCA.  If you are unsure of your obligations under the FDCA or whether a particular action complies with the law, please contact us immediately.  

Other Distributor Requirements  

  • Maintain all facilities where the Company’s products are manufactured or stored in a manner that ensures the health and safety of the product (see non-exhaustive list below); maintain written procedures in accordance with the same  
  • Provide timely and recurring certifications of the above to the Company   
  • Supply the Company with any requested or required documentation demonstrating compliance with the same  
  • Timely notify the Company in the event of: 
  • (1) any notice of inspection; 
  • (2) the results of any such inspection; 
  • (3) any notice of violation resulting from the same; and 
  • (4) plans to take corrective actions 
  • Timely notify the Company in the event of any deviation from typical production processes (e.g., damaged or lost materials; materials kept outside of normal operating conditions; carrier issues)
  • Timely notify the Company in the event of any consumer complaints received 
  • Agree that the distributor shall not sub-contract any responsibilities delegated to the distributor without the express, written permission of the Company 
  • Agree that the distributor shall indemnify the Company for any losses related to non-compliance with these provisions  

Health and Safety Requirements 

The following is a non-exclusive list for all facilities where the Company’s products are manufactured or stored.  

Grounds: 

  • Maintain outside that is free of weeds, grass and bushes that might harbor pests 
  • Avoid standing water inside and outside of facility 
  • Ensure adequate lighting 
  • Prevent nesting of rodent and birds near access points (doors, windows, etc.)  

Facilities: 

  • Ensure adequate ventilation and climate control 
  • Ensure adequate restrooms and handwashing facilities 
  • Maintain personal hygiene policies 
  • Maintain separate eating and smoking/vaping areas 
  • Maintain adequate waste disposal procedures 
  • Maintain a pest-control program 
  • Conduct periodic cleaning  

Equipment: 

  • Ensure equipment is maintained in precise, calibrated, functional, and clean/sanitary conditions 
  • Prevent buildup of debris and take steps to avoid cross-contamination 
  • Ensure that employees are properly trained and certified on the proper use of equipment  

Storage: 

  • Ensure that storage locations are properly labeled 
  • Maintain an inventory control system (e.g., Quality Management Systems, First-in-first-out, etc.)  

Safety: 

  • Facility should conduct routine audits to ensure: 
  • Prevention of access by minors 
  • Prevention of tampering 
  • Prevention of access by unauthorized individuals 

 All retailers must:   

  1. Enter into a written agreement with the Company to do business, which shall include an indemnification provision negotiated by the parties. To the extent that the Company has established business relationships with existing distributors, the Company will provide a shortened version of these guidelines to the those distributors with a future purchase order, as well as a website link to these full Guidelines, to put them on notice of the Company’s positions.  Company requires down-stream distributors and retailers to comply with these requirements by establishing and enforcing contractual penalties for such contracted parties. 
  2. Screen retailers in advance of establishing or renewing distribution agreements based on the strength of the retailers’ age verification policies. 
  3. Establishing and publicize a hotline for anonymous reporting of noncompliant sales 
  4. Implement a policy of notifying FDA of retailer violations. 
  5. Check photo ID of everyone under age 27 who attempts to purchase e-cigarettes or other ENDS. Sell only to people who are old enough (at least 21 years old throughout the United States) confirmed using valid ID for any face-to-face transactions with consumers. If sales are made online, use adequate age-verification technology to prevent underage access to the website and to prevent underage sales through the Internet.  Age-verification technology should include independent, third-party age- and identity-verification services that compare customer information against third-party data sources.  The consumer’s age should be verified using reputable age-verification software such as AgeMatch (Veratad), Agechecker.net or Bluecheck. For sales made to California residents, follow heightened online age verification requirements as provided in California’s Stop Tobacco Access to Kids Enforcement Act (STAKE Act). Ensure compliance with state laws on the minimum purchase age for vapor products and delivery sales requirements as provided in Attachment I.  
  6. If sales of flavored, cartridge-based ENDS products are made online, such sales must include a limit on the quantity of such flavored ENDS products (other than tobacco and menthol ENDS products) that a customer may purchase within a given period of time. This limit should correspond to the amount an individual can reasonably consume within the specified time period.  
  7. Not sell e-cigarettes or other ENDS in a vending machine unless in an adult-only facility.
  8. Not sell or distribute e-cigarettes or other ENDS without a required nicotine warning statement on the package. Do NOT display advertisements for e-cigarettes or other ENDS without a required nicotine warning statement.  
  9. Not give out free samples to individual consumers, including any tobacco product components or parts 
  10. Not bundle the Company’s product with e-liquids without the Company’s express permission.   
  11. Not bundle the Company’s products with any food, beverage, drug or other consumable products. 
  12. Not break open packages to sell products in smaller amounts. 
  13. Implement appropriate retailer hiring and management practices as part of a comprehensive retailer training program intended to reduce the illegal sale of tobacco products to persons under the age of 21. This may include requiring clerks who sell tobacco to be at least 21 years of age (studies have shown that clerks under the age of 18 are more likely to sell tobacco to minors than are older clerks). Notify applicants for positions that involve selling tobacco or ENDS products both verbally and in writing of the importance of complying with laws prohibiting the sale of  tobacco or ENDS products to youth, and require these individuals to sign an acknowledgement stating that they have read and understand the information. Current employees should be given these notifications and should be required to sign an acknowledgement stating that they have read and understand the information. Consider establishing company policies that take employee performance on compliance checks into account in company decisions about compensation, promotion, and retention. Consider establishing disciplinary sanctions for employee noncompliance. 
  14. Develop an internal compliance check program, such as a mystery shopper program. In this type of program, use either a person of legal age who is younger than 27 years old (to test whether clerks are requesting photographic identification) or a person who is under the legal age to buy tobacco (to test whether clerks are both requesting photographic identification and refusing to make a sale to underage youth). Internal compliance checks should be performed at random and varying times of the day and at least once every six months. Employees who fail the internal compliance check should be notified immediately and given additional training, and this should be appropriately documented. 
  15. Not modify any Company labels or advertising without express written permission.   
  16. Agree to abide by all FDA and state law requirements regarding advertising and marketing of tobacco products, and indemnify and hold harmless Company for any violations of such laws.  For sales made to California residents, ensure compliance with any applicable California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) product packaging and website warning requirements.   
  17. Agree not to market the Company’s products for anything other than recreational adult vaping or as directed by the Company (i.e., no “off label” uses).
  18. Ensure that it does not make, allow others within its control to make, or publicize or publish or distribute, any marketing materials, statements or claims, including but not limited to product review videos and articles (regardless of online or offline), without prior written authorization by Company regarding Company’s products.  If prior written authorization is received, any such marketing, including endorsements by social media influencers, must include necessary and appropriate disclosures about the health risks of nicotine, and any material connection must be clearly and conspicuously disclosed in such endorsements.  
  19. Obtain appropriate product liability and other insurance and include Company as an additional insured when applicable. 
  20. Not make any health or therapeutic claims, including smoking cessation claims, about the Company’s products. 
  21. Not make any claims that the Company’s products: (i) present a lower risk of disease or is less harmful than another tobacco product; or (ii) contain a reduced level of, or is free from, a substance, or that exposure to a substance is reduced or eliminated.  

 Retailers are responsible for adherence to all other FDCA requirements and this non-exhaustive list may be modified from time-to-time to aid distributors in identifying obligations under the FDCA.  If you are unsure of your obligations under the FDCA or whether a particular action complies with the law, please contact us immediately. 

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