Latest guidance issued by FDA on requirements for US Vape Shops

Tobacco product manufacturers are required to comply with certain requirements under Section 904(a) of the Federal Food, Drug and Cosmetic Act (FD&C Act). What does this have to do with vape shops you may wonder? Well, guidance confirms that these requirements also apply to ENDS retail establishments under certain circumstances. This article outlines what’s been announced, who this guidance will apply to and what activities it relates to.

Background on the guidance

The FD&C Act authorizes the Food and Drug Administration (FDA) to regulate the manufacture of new tobacco products, and all other products that meet the statutory definition of a tobacco product, including ENDS. Requirements in place for these manufactures also apply to retail establishments that mix or prepare e-liquids or create or modify aerosolizing apparatus.

The FDA have recently published a final guidance document; Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Food, Drug and Cosmetic Act Requirements to Vape Shops. This explains which activities subject vape shops to additional requirements under the FD&C Act, and identifies the limited circumstances under which they do not intend to enforce compliance.

What activities does the guidance cover?

Section 904(c) of the FD&C Act requires the submission of information when ‘changing any, or the quantity of any, additive in an existing tobacco product or introducing into interstate commerce a tobacco product that was not previously on the market’.

Vape shops that modify a product so that it is defined as a new tobacco product, or that are engaged in the manufacture, preparation, compounding or processing of tobacco products are required to comply with certain requirements. Examples of applicable activities include:

• Modifying a product outside the marketing authorization order for that product
• Modifying a product that does not yet have a marketing authorization order (unless modifications are consistent with the specifications provided by the original manufacturer)
• Refilling open ENDS product (unless the vape shop does not make any further modifications to the product or e-liquid before, during or after the refill, that are outside the marketing authorization order or, in the case where an order doesn’t exist, that are inconsistent with the original manufacturer specifications)
• Modifying a closed ENDS to refill it for a customer
• Repairing or modifying an atomizer head outside of the marketing authorization order
• Replacing the coil in an ENDS product that was on the market as of August 8, 2016, but does not have a marketing authorization order with coils that have a different ohm and/or wattage rating (unless specifications aren’t issued by the original manufacturer)
• Assembling a custom final product from components or parts sold individually or from multiple pre-built kits, that were on the market as of August 8, 2016, but that do not yet have marketing authorization orders.

What are the requirements vape shops need to comply with?

Vape shops that are engaged in such certain activities are subject to requirements to provide ingredient listings, report Harmful and Potentially Harmful Constituents (HPHCs) and submit health documents. Those that modify a product so that it is defined as a new tobacco product are also required to comply with the premarket authorization requirements.

Vape shops that are engaged in the manufacture, preparation, compounding or processing of tobacco products are also required to comply with establishment registration and product listing requirements.

As a side note, the most recent guidance has confirmed that the FDA does not intend to enforce a separate requirement that tobacco products in package form bear a label that states the percentage of foreign and domestic grown tobacco, in the case of ENDS products. They recognize that in many circumstances this would be difficult to quantify for such products.

How can Broughton help vape shops?

Our experienced team have operated in the ENDS market for almost 10 years and offer an in-depth, commercially-driven understanding of US regulatory requirements. As a privately-owned laboratory delivering analytical, scientific and regulatory services exclusively within the ENDS sector, we are committed to accelerating a smoke-free future, by helping manufacturers and retailers comply with HPHC & PMTA requirements. Book a meeting with us today to discuss your specific requirements.