FDA recently issued the first marketing orders for new waterpipe (hookah) filler tobacco products. Although there are hookah products currently on the market either because they are grandfathered or are subject to current enforcement discretion, these are the first new hookah products to be reviewed and authorized by FDA under the agency’s premarket review standards. In total, 10 products manufactured by Al Fakher Distribution USA, Inc. were made eligible to enter into interstate commerce.
Four Exemption from Substantial Equivalence (EX REQ) Products
On April 3, FDA issued four orders under the exemption from substantial equivalence (EX REQ) pathway:
- Al Fakher Plum Flavour 250 grams
- Al Fakher Golden Eskandarani Apple Flavour 250 grams
- Al Fakher Cherry with Mint Flavour 250 grams
- Al Fakher Golden Strawberry Flavour 250 grams
Under the EX REQ pathway, before a tobacco product that receives an exempt order can be legally marketed, the applicant must (1) submit an Abbreviated Report; and (2) ninety days must pass since FDA’s receipt of the Abbreviated Report before the products may be introduced to the market. Upon administrative review of Al Fakher’s Abbreviated Report, FDA notified them of the 90-day waiting period, which ended on July 8, 2020.
EX REQ is one of three FDA pathways—in addition to premarket tobacco product applications and substantial equivalence reports—for companies that seek to introduce new tobacco products to the U.S. market. Tobacco companies may submit EX REQs if the proposed new tobacco product is modified from a legally marketed tobacco product and the modifications are minor – such as adding or deleting a tobacco additive or increasing or decreasing the quantity of an existing tobacco additive. In addition, companies must demonstrate that a substantial equivalence report is not necessary and that an exemption is otherwise appropriate. FDA anticipates that EX REQ may be a viable pathway to market a number of deemed tobacco products, such as waterpipes (also known also known as waterpipe tobacco, maassel, shisha, narghile, or argileh), cigars, and pipes.
Six Substantial Equivalence (SE) Products
On June 30, FDA issued six orders under the substantial equivalence (SE) pathway for additional waterpipe filler products manufacturer by the company:
- Al Fakher Melon Flavour 50 grams
- Al Fakher Pineapple Flavour 50 grams
- Al Fakher Coconut Flavour 50 grams
- Al Fakher Mango Flavour 50 grams
- Al Fakher Plum Flavour 50 grams
- Al Fakher Cocktail Flavour 50 grams
Under the SE pathway, these six products were immediately eligible to be marketed.
Companies that seek to market a new tobacco product via the SE pathway must demonstrate that the proposed new products have either the same characteristics as predicate products or have different characteristics than predicate products but do not raise different questions of public health. In this case, the corresponding predicate products are all grandfathered, meaning they were commercially marketed in the United States other than exclusively in test markets as of Feb. 15, 2007. The only change from the predicate products was reducing the quantity of each product from 250 grams to 50 grams. Based on the FDA’s experience with SE reports, FDA determined that the products met the statutory criteria to issue SE orders.
Premarket Application Deadline for Hookah Tobacco and Other Deemed Products
As a reminder, applications for deemed new products on the market as of Aug. 8, 2016 – including waterpipe (hookah) products – must be submitted by Sept. 9, 2020. Manufacturers of hookah tobacco who wish to market a new tobacco product that may be similar to a tobacco product that is grandfathered, or to one previously found to be substantially equivalent, may want to consider the SE and EX REQ pathways. Learn more on FDA’s website.
