FDA Compliant Packaging and Advertising 1
E-Alternative Solutions & Me E-Alternative Solutions Founded in 2015; President is Jacopo D Alessandris Sister company of Swisher International, Inc. Markets closed system, subohm device Expanded launch of Cue Vapor System in 2017 Chris Howard General Counsel & CCO since July 2016 Formerly General Counsel & CCO of Fontem Ventures (blu ecigs) Treasurer, Board Member for Vapor Technology Association 2
Disclaimer The information presented is for informational purposes only and not for the purpose of providing legal advice. You should contact your attorney to obtain advice with respect to any particular issue or problem. Participation in this presentation does not create an attorney-client relationship between the presenter and you. The opinions expressed during this presentation are the opinions of the individual author and may not reflect the opinions of EAS. 3
EAS Proprietary and Confidential Information 4
Packaging FDA Requirements Nicotine Warning Placement and Font Space Requirements and Size Punctuation and Orientation Other Labeling Statements California Proposition 65 5
21 CFR 1143.3 Requirements Warning requirements apply to covered tobacco products A covered tobacco product is defined as any tobacco product deemed to be subject to the Tobacco Control Act, but excludes any component or part that is not made or derived from tobacco. See 21 C.F.R. 1140.3. E-liquids containing nicotine derived from tobacco are covered tobacco products Pre-filled devices containing nicotine e-liquid are covered tobacco products Zero-nicotine e-liquids that do not contain any other tobacco-derived substances are not covered tobacco products Open-system devices and components and parts (i.e., hardware, batteries, tanks, etc.) sold separately from e-liquid are not covered tobacco products 6
FDA Nicotine Warning 21 CFR 1143 Compliance Deadline: August 10, 2018 Required language: WARNING: This product contains nicotine. Nicotine is an addictive chemical. FDA provides specific guidance for small packages, see 21 CFR 1143(d) which provides that the warning may appear on the carton, outer container, wrapper or permanently affixed tag. 7
Warning Placement and Font Warnings must appear directly on the package and must be clearly visible underneath any cellophane or other clear wrapping as follows: Placement: Be located in a conspicuous and prominent place on the two principal display panels of the package, and the warning area must comprise at least 30% of each of the principal display panels; Font Size: Be printed in at least 12-point font size and ensure that the required warning statement occupies the greatest possible proportion of the warning area set aside for the required text; Appearance: Be printed in conspicuous and legible Helvetica bold or Arial bold type (or other sans serif fonts) and in black text on a white background or white text on a black background in a manner that contrasts by typography, layout, or color, with all other printed material on the package; Punctuation: Be capitalized and punctuated as indicated above; and Position: Be centered in the warning area in which the text is required to be printed and positioned such that the text of the required warning statement and the other information on the principal display panel have the same orientation. 8
Warning Space Requirements/Size 70% 6 mg/ml nicotine 6 mg/ml nicotine Placement: Be located in a conspicuous and prominent place on the two principal display panels of the package, and the warning area must comprise at least 30% of each of the principal display panels 30% 10 ml bottle WARNING: This product contains nicotine. Nicotine is an addictive chemical. 10 ml e-liquid WARNING: This product contains nicotine. Nicotine is an addictive chemical. Font Size: Be printed in at least 12-point font size and ensure that the required warning statement occupies the greatest possible proportion of the warning area set aside for the required text 9
Principal Display Panels Many manufacturers are wondering how to determine the principal panels on bottles Answer is it depends Remember some bottles may qualify for the small package warning Have to use judgment on the bottle In our example, the front and back facing information makes it easier Bottles with a front label only place label on front and back Bottles with wrap around label that has front and side data place label on front and side 6 mg/ml nicotine 10 ml e-liquid WARNING: This product contains nicotine. Nicotine is an addictive chemical. NOT FOR SALE TO MINORS. INGREDIENTS: Vegetable Glycerin, Propylene Glycol, Artificial and Natural Flavors, Nicotine. Flavors made in USA with domestic and imported ingredients. Distributed by darn good vape, Inc. (Nevada, Mo 68304). WARNING: This product contains nicotine. Nicotine is an addictive chemical. 10
Font, Punctuation and Orientation 6 mg/ml nicotine 10 ml bottle WARNING: This product contains nicotine. Nicotine is an addictive chemical. 6 mg/ml nicotine 10 ml e-liquid WARNING: This product contains nicotine. Nicotine is an addictive chemical. Appearance: Be printed in conspicuous and legible Helvetica bold or Arial bold type (or other sans serif fonts) and in black text on a white background or white text on a black background in a manner that contrasts by typography, layout, or color, with all other printed material on the package Punctuation: Be capitalized and punctuated as indicated in the rule; and Position: Be centered in the warning area in which the text is required to be printed and positioned such that the text of the required warning statement and the other information on the principal display panel have the same orientation 11
Other Labeling Requirements (FDCA 903(a)(2)) Tobacco products must bear a label containing: The name and place of business of the product manufacturer, packer or distributor An accurate statement of the quantity in terms of weight, measure, or numerical count Percentage of domestic and foreign grown tobacco* Statement Sale only allowed in the United States 12
Name & Place of Business The name and place of business of the product manufacturer, packer or distributor NOT FOR SALE TO MINORS. INGREDIENTS: Vegetable Glycerin, Propylene Glycol, Artificial and Natural Flavors, Nicotine. NOT FOR SALE TO MINORS. INGREDIENTS: Vegetable Glycerin, Propylene Glycol, Artificial and Natural Flavors, Nicotine. Flavors made in USA with domestic and imported ingredients. Distributed by darn good vape, Inc. (Nevada, Mo 68304). WARNING: This product contains nicotine. Nicotine is an addictive chemical. Flavors made in USA with domestic and imported ingredients. Distributed by darn good vape, Inc. (Nevada, Mo 68304). WARNING: This product contains nicotine. Nicotine is an addictive chemical. 13
Contents 6 mg/ml nicotine Ensure an accurate representation of what is in the package Cigarettes were easy 20 Class A Cigarettes 903(a)(2)(B) states: an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count In the example, we list the quantity of the contents 10 ml e-liquid The content requirement does not seem to require any description of PG/VG ratios or other specific ingredients 6 mg/ml nicotine 10 ml e-liquid WARNING: This product contains nicotine. Nicotine is an addictive chemical. 10 ml bottle WARNING: This product contains nicotine. Nicotine is an addictive chemical. 14
Sale Only Allowed in the United States Sale only allowed in the United States The statement Sale only allowed in the United States is to be included on outer packaging such as cartons and boxes as well as package labels Sale only allowed in the United States 2016 darn good vape Inc. darn good vape is a trade mark of darn good vape Inc. Purpose to prevent illicit trade in tobacco products 2016 darn good vape Inc. darn good vape is a trade mark of darn good vape Inc. 15
Percentage of Domestic and Foreign Grown Tobacco FDA recognized the difficulty in quantifying the amount of domestic and foreign grown tobacco that contributes to the nicotine in e-liquids In draft guidance issued in January 2017* FDA indicated that it would not enforce the domestic/foreign percentage provisions, section 903(a)(2)(c), at this time * See, Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops, January 2017 16
903(a)(3) - Prominence On packages all labeling must be prominent and in such terms that render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use (903(a)(3)) This means that required language on package labels should not be in such fine print to be unreadable to average consumers nor so similar to branding fonts to go unnoticed 17
Small Package Accommodation (d) Small packages. A tobacco product that would otherwise be required to bear the warning in paragraph (a)(1) of this section but is too small or otherwise unable to accommodate a label with sufficient space to bear such information is exempt from compliance with the requirement provided that the information and specifications required under paragraphs (a)(1) and (2) of this section appear on the carton or other outer container or wrapper if the carton, outer container, or wrapper has sufficient space to bear the information, or appear on a tag otherwise firmly and permanently affixed to the tobacco product package. In such cases, the carton, outer container, wrapper, or tag will serve as the location of the principal display panels. 18
Alternate Warning for Non-Nicotine Products 21 CFR 1143.3 allows for a non-nicotine warning for covered tobacco products that do not contain nicotine The rule states that the warning, This product is made from tobacco should appear on all package and advertisements in accordance with the requirements of this part (the rule) Alternate warning must follow all of the same rules (e.g., placement, text, etc., as the nicotine warning ( in accordance wit the requirements of this part. ) 19
California Proposition 65 Future Requirement Revised Prop 65 Warning is required August 2018 Include Prop 65 warning for all products which contain nicotine. a. Fonts, Size and Placement. Section 25249.12, California Health and Safety Code; Title 27 California Code of Regulations Article 6, Section 25602-603 sets forth details regarding required California Proposition 65 Warning statement: (i) An on-product warning that complies with the content requirements in Section 25603(b). The entire warning must be in a type size no smaller than the largest type size used for other consumer information on the product. In no case shall the warning appear in a type size smaller than 6-point type. (ii) A symbol consisting of a black exclamation point in a yellow equilateral triangle with a bold black outline. Where the sign, label or shelf tag for the product is not printed using the color yellow, the symbol may be printed in black and white. The symbol shall be placed to the left of the text of the warning, in a size no smaller than the height of the word WARNING. and (iii) The word WARNING in all capital letters and bold print. (iv) For exposures to listed reproductive toxicants, the words, This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to www.p65warnings.ca.gov. 20
Deadlines - 21 CFR 1143 The Tobacco Control Act (and implementing regulations) require that: Products must be manufactured with compliant packages as of August 10, 2018 All distribution of non-compliant packages must end as of September 11, 2018 Retailers cannot offer for sale, sell, distribute, or import products with non-compliant packages as of August 10, 2018, UNLESS the retailer falls within the safe harbor: A retailer will not be in violation of this section for packaging that (i) Contains a health warning; (ii) Is supplied to the retailer by the tobacco product manufacturer, importer, or distributor who has the required state, local, or Alcohol and Tobacco Tax and trade Bureau (TTB) issued license or permit, if applicable, and (iii) Is not altered by the retailer in a way that is material to the requirements of this section. 21 CFR 1143(a)(3)(ii), Distributors and retailers may continue to sell and distribute the tobacco product packages after the effective date, but only if the products were manufactured before the effective date of the new required warning statement for covered tobacco products. Manufactures, importers, distributors and retailers who direct their own advertising must include the addictiveness warning as of August 10, 2018 (21 CFR 1143), and Products are misbranded if they do not include the FDCA 903(a)(2) required labeling as of August 10, 2018. 21
Packaging Question Selling Goods with Non-Compliant Labels Once label regulations go into effect, are bottles currently on the shelf grandfathered in? Or do we have to swap those out prior to that date? FDA Guidance Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule" (August 2017) states: Manufacturers cannot manufacture products with non-compliant packages after August 10, 2018 Manufacturers cannot distribute such products irrespective of date of manufacture after September 11, 2018 Retailers cannot offer for sale, sell, distribute or import products with non-compliant packages unless the retailer falls within the retailer safe harbor after August 10, 2018 A retailer of any cigarette tobacco, roll-your-own tobacco, or covered tobacco products (other than cigars) will not be in violation of this section for packaging that: (i) Contains a health warning; (ii) Is supplied to the retailer by the tobacco product manufacturer, importer, or distributor who has the required state, local, or Alcohol and Tobacco Tax and Trade Bureau (TTB)-issued license or permit, if applicable; and (iii) Is not altered by the retailer in a way that is material to the requirements of this section. Distributors and retailers may continue to sell and distribute the tobacco product packages after the effective date, but only if the products were manufactured before the effective date of the new required warning statement for covered tobacco products. What does this mean? If you are a manufacturer stop making non-compliant by August 10, stop distributing by September 11 If you are retailer selling off product should be acceptable under certain circumstances 22
Packaging Question Selling Goods with Non-Compliant Labels Been wondering the same thing. I have a ton of labels that I need to use and I hope to use them until the day of. FDA Guidance Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule (August 2017) states: Manufacturers cannot manufacture products with non-compliant packages after August 10, 2018 Manufacturers cannot distribute such products irrespective of date of manufacture after September 11, 2018 So one can manufacture with those labels until the deadline, but cannot distribute those products after September 11, 2018 23
Packaging Question Adding a Sticker or Label Yourself Can we add a warning label? Short answer depends If you are not a manufacturer, any repackaging of the product makes you a manufacturer and if not registered the product is adulterated under the FDCA If you are a manufacturer, you can repackage your products, but those products must be in compliance with all labeling and packaging requirements 24
Submission Question Changes to Packaging Question asked about submitting labeling changes to FDA Section 905(i)(3) of the FD&C Act requires the following changes to the product list to be reported twice a year Guidance indicates that [a]ny material change in any information previously submitted must be provided Updates to representative labeling and advertising could be deemed material If necessary would be completed in FURLS at the June/December update if you are domestic manufacturer 25
EAS Proprietary and Confidential Information 26
Advertisements 21 CFR 1143.3(d) requires the FDA Nicotine Warning on all forms of advertising Specific guidance is provided in the rule for print advertisements No guidance is provided for other media such as electronic, television or radio Even in the absence of guidance, the warning statement is still required (21 CFR 1143.3(d)(1)) 27
Advertisement Warning Requirements The Tobacco Control Act and implementing regulations require that all advertisements for ENDS products bear the FDA Nicotine Warning effective August 10, 2018 (21 CFR 1143) Required language. WARNING: This product contains nicotine. Nicotine is an addictive chemical. Print and other advertisements with a visual component must bear the required warning statement in the upper portion of the area of the advertisement. This includes, for example: Signs, Shelf-talkers, Internet web pages, and Electronic mail correspondence. 28
Advertisements - Placement Occupy at least 20% of the upper portion area of the advertisement WARNING: This product contains nicotine. 20% Nicotine is an addictive chemical. 80% To Learn More, Contact Customer Service at (800) 555-5555 or Visit darngoodvape.com NOT FOR SALE TO MINORS 2016 darn good vape Inc. darn good vape is a trade mark of darn good vape, Inc. 29
Advertisements Font Size Appear in at least 12-point font size and ensure that the required warning statement occupies the greatest possible proportion of the warning area set aside for the required text WARNING: This product contains nicotine. Nicotine is 20% an addictive chemical. 80% To Learn More, Contact Customer Service at (800) 555-5555 or Visit darngoodvape.com NOT FOR SALE TO MINORS 2016 darn good vape Inc. darn good vape is a trade mark of darn good vape, Inc. 30
Advertisements - Appearance Appear in conspicuous and legible Helvetica bold or Arial bold type (or other similar sans serif fonts) and in black text on a white background or white text on a black background in a manner that contrasts by typography, layout, or color, with all other material on the advertisement WARNING: This product contains nicotine. 20% Nicotine is an addictive chemical. 80% To Learn More, Contact Customer Service at (800) 555-5555 or Visit darngoodvape.com NOT FOR SALE TO MINORS 2016 darn good vape Inc. darn good vape is a trade mark of darn good vape, Inc. 31
Advertisements - Punctuation Be capitalized and punctuated as indicated in the rule WARNING: This product contains nicotine. 20% Nicotine is an addictive chemical. 80% To Learn More, Contact Customer Service at (800) 555-5555 or Visit darngoodvape.com NOT FOR SALE TO MINORS 2016 darn good vape Inc. darn good vape is a trade mark of darn good vape, Inc. 32
Advertisements - Positioning Be centered in the warning area in which the text is required to appear and positioned such that the text of the required warning statement and the other textual information in the advertisement have the same orientation WARNING: This product contains nicotine. 20% Nicotine is an addictive chemical. 80% To Learn More, Contact Customer Service at (800) 555-5555 or Visit darngoodvape.com NOT FOR SALE TO MINORS 2016 darn good vape Inc. darn good vape is a trade mark of darn good vape, Inc. 33
Advertisements - Border Be surrounded by a rectangular border that is the same color as the text of the required warning statement and that is not less than 3 millimeters or more than 4 millimeters WARNING: This product contains nicotine. 20% Nicotine is an addictive chemical. 80% To Learn More, Contact Customer Service at (800) 555-5555 or Visit darngoodvape.com NOT FOR SALE TO MINORS 2016 darn good vape Inc. darn good vape is a trade mark of darn good vape, Inc. 34
Generously Apply Guidance to Other Ad Forms While FDA only provided guidance for print advertisements, other forms of advertising are not exempt Industry must aggressively follow advertising rules Examples follow: 35
Billboards Warning Compliance Idea: Treat as print advertising follow those rules Other considerations: Placement is Key No Billboards Within 500 Feet of: Schools Youth Oriented Facilities Child Care Facilities Otherwise Treat Like Print Ads for Content 36
Radio/Television Warning Compliance Ideas: TV run visual warning statement with correct font and statement for 20% of advertising time at beginning and end TV run visual warning statement with correct font and statement continuously covering 20% of the screen space Radio speak warning statement for 20% of advertising time at beginning and end Other considerations: Radio Show Content Should Be Directed to Adults Look to Arbitron Data for 85% Adult Listeners TV - 85% Adult Viewership Use Nielsen data Talent/Spokespeople Should be and appear to be 25 Celebrities should have 85% adult following Compare: Rush Limbaugh vs. Ryan Gosling Ensure scripts/ad-lib is reviewed for compliance 37
Internet Social Media Web/Mobile Banner Warning Compliance Ideas: Treat like print ads and apply to top 20% where practicable Develop warning statements for e-mails Other considerations: Internet same rules apply seek verified 85% adult visits to site Social Media Restrict to adult only social media Restrict your pages to adult only social media Banner Ads Link your banner ads to a webpage with required legal language (e.g., warnings) If no links add warnings and other information Same adult readership rules apply 38
Sponsorships Warning Compliance Ideas: Ensure all branding includes warning statements This includes tents, vans, etc. Other considerations: 85% Adult participation Compare: Burning Man Event to NFL game Other Restrictions like use of talent, coupons, free samples, health claims still apply 39
Point of Sale Advertising Posters, change mats, etc., should be treated like printed advertising materials Store fixtures and furniture Shelf talkers need warnings Branded furniture needs warnings Need to consider methods: Top 20% of the piece of furniture Top 20% of the messaging piece 40
QUESTIONS/DISCUSSION 41