ECigIntelligence - U.S. e-liquid manufacturers face deluge of FDA paperwork
ECigIntelligence - 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.”
Freddie Dawson - ECigIntelligence staff