In early 2011 the FDA issued guidance asking for 905(j) reports to seek approval for cigarette rolling papers introduced or changed (including a change in design) after February 15, 2007.
They estimate that it takes 360 hours to prepare the 905(j) report (not kidding). Plus they also want ingredient submissions for every product. So – private label cigarette rolling papers introduced or changed after February 15, 2007 have to file this report and submit ingredients. It’s an incredible burden and one that costs around a hundred thousand dollars. Think of it this way, if a typical lawyer gets paid $250/hr and it takes 360 hours to do the 905(j) report; that is $90,000.00 plus laboratory and filings costs!
The regulation requires reporting BEFORE you introduce a product to market. Then you are supposed to wait for approval from them. So you could spend this money, wait years and then get a negative response.
Here is what the FDA said: At this time, however, FDA intends to limit its enforcement of the requirements of Section 910 and 905(j) to finished, regulated tobacco products. These finished, regulated tobacco products include the products named in section 901(b) (i.e. cigarettes, smokeless tobacco and roll-your-own tobacco) and tobacco products deemed by regulation to be regulated under chapter IX, as well as the component parts of regulated tobacco products sold or distributed for consumer use, (e.g., cigarette rolling papers, filters, or filter tubes sold separately to consumers or as part of kits).
The time required to complete this information collection is estimated to average 360 hours per response, including the time to review instructions, search existing data sources, gather the data needed, and complete and review the information collection.
A new tobacco product is defined at section 910(a)(1) as “any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.” This part that says “including a change in design” is what caused us to discontinue offering custom cigarette rolling papers.
This 905J report is IN ADDITION to the component submission guidance published by the FDA (so besides submitting your components, there is also this separate 905J report).
Here’s a warning for our customers – others are out there still offering custom cigarette rolling papers. They sell Chinese cigarette rolling papers shipped directly to you from China with your brand on it. This means you are the importer and the person on the hook. Even if they imported them for you – if it’s your brand you’re likely responsible for getting 905J approval from the FDA, and for component (ingredient) submissions! ** (The broker who tries to sell you these Chinese papers might claim they submitted to the FDA for you, or that they are “compliant” or that they are “the same as older papers”. Insist on copies of their submissions, component/ingredient reports and 905J report for your specific brand. Save those copies in case the FDA later demands them from you!).
HBI takes regulatory issues and compliance very seriously. We do our best to work with the FDA and to legally challenge them only when we feel it is absolutely necessary. Our Federal suit against the FDA in 2009 is an example of how seriously we take compliance.
*Guidance for Industry and FDA Staff: Section 905(J) Reports: Demonstrating Substantial Equivalence for Tobacco Products
**The upshot is, even though we adamantly object to the FDA’s authority to promulgate these regulations, for the time being, it seems the industry cannot ignore them. They do threaten some serious implications. This information above is not legal advice and should not be relied upon on as such. Instead I urge you to speak with an FDA legal specialist ad-nauseam about this and get their professional opinion.
A link to the FDA information page is provided here
PS: We asked the FDA if brand name changes (custom papers) can qualify for the exemption, this is the answer they gave us:
Thank you for your inquiry. Please refer to the “Overview Questions: Exemptions from Substantial Equivalence Requirements” which can be found on http://www.fda.gov/TobaccoProducts/ResourcesforYou/ForIndustry/ucm261935.htm. The SE Exemption pathway is available for a minor modification to additives in tobacco products that meet the statutory criteria and can be sold under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This pathway is not applicable to other modifications to tobacco products (e.g., design features, brand/subbrand name, heating source). Additives are defined in FD&C Act Section 900 as: “any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any tobacco product (including any substances intended for use as a flavoring or coloring or in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding), except that such term does not include tobacco or a pesticide chemical residue in or on raw tobacco or a pesticide chemical” (21 U.S.C. 387(1)). Substantial equivalence exemption requests may be submitted only by the manufacturer of a legally marketed tobacco product for a minor modification to that manufacturer’s product. The request must be for minor modification to additives (adding or deleting a tobacco additive or increasing or decreasing a quantity of an existing additive).”