American e-liquid manufacturers face a significant rise in paperwork from the deeming regulations currently being finalised by the U.S. Food and Drug Administration (FDA), a consultancy has warned.
Many manufacturers could be taken unawares, particularly smaller operations with no previous experience in the pharmaceutical or tobacco sectors, said Gretchen Rizor, a specialist in training and validation at consultancy InstantGMP in North Carolina.
While it is uncertain what the FDA’s final regulations will include, it is likely that where manufacturing is concerned they will be similar to those governing areas such as pharmaceuticals, tobacco and dietary supplements, she added.
Labelling, training and record-keeping requirements are all likely to increase and manufacturers should be prepared to face some major changes in the way they operate. “For example, the quantity of each ingredient must be disclosed on the label,” Rizor said. “There are no more ‘secret recipes’ – transparency is the name of the game.”
Manufacturers will have to keep track of training in order to show that staff are competent in the tasks they need to perform. Standard operating procedures (SOPs) – directives on how tasks should be performed – will also be required.
“Confusing matters is that the FDA says we must follow rules but they don’t say how to follow them. They don’t tell us what the limits exactly are. For example, the Japanese give very strict limitations on things like heavy metals,” said Rizor. “It’s the same with the EU [European Union], but the FDA gives leeway, which while lenient adds confusion.”
Pre-market tobacco product applications (PMTAs) will also likely be required for new e-cigarette products. This means that manufacturers will need full reports on health impacts, backed up by research on topics such as long-term use under different conditions, or an examination of what exactly constitutes a “puff” of an e-cigarette in order to justify dosage measurements. Many e-liquid manufacturers may not be ready to cope with this, she added.
“There’s a need for manufacturers to think paperwork per flavour, strength and batch size. It will scale up and down with recipe but manufacturers should be prepared to submit a lot of paperwork.”
What This Means: E-liquid manufacturing may not be viable forever on a mom-and-pop scale anyway. It’s already likely that the smaller outfits will eventually be either forced out or bought out as the e-cigarette sector grows and consolidates. However, if FDA regulations come into effect as soon as some are predicting – or if the industry continues to support smaller, independent e-liquid manufacturers – InstantGMP’s warnings could be very pertinent.
– Freddie Dawson ECigIntelligence staff
Photo: Evelyn Berg