FDA Is Getting Ready to Go After Non-Compliant Manufacturers

The agency is hiring and training inspectors to find violators

1
FDA-restricted

With registration and product listings due soon from e-liquid and other vape manufacturers, the FDA is making plans to inspect facilities — and to enforce their rules.

Any business that makes, packages, repackages, or labels vaping products is considered a manufacturer, and all are required to register all facilities with the federal agency. After the third delay announced last week, registration and product listings are now due on Oct. 12.

A vape shop is also considered a manufacturing facility if employees modify products, refill closed system products, or building coils. Assembling devices that are intended to be used together, repairing broken products, and showing customers how products work do not qualify as manufacturing.

Vape shops and retailers that don’t manufacture or modify products are not required to register or provide product listings. Neither are foreign manufacturers — for now anyway.

But vape shops that make e-liquid on site, and all manufacturers of e-liquid and other vape products, will be subject to FDA enforcement of the rules after the deadline. Facilities that aren’t registered, or make products not listed with the FDA, or make products they can’t prove were in production before Aug. 8, 2016, are subject to penalties for selling “misbranded” or “adulterated” products.

A finding of intentional violation of the rule against adulterated products can result in fines up to $250,000 per violation. Adulterated products would also be seized, and manufacturers could also be subject to state and local penalties too.

No one knows what the FDA intends to do. The agency may not enforce the rules aggressively right away — or even at all. The new leadership seems to have some sympathy for the vaping industry.

On the other hand, the FDA is still engaged in public relations campaigns to demonize vaping, and doesn’t seem particularly thrilled with the prospect of thousands of flavored e-liquid products being available. With more than two million product listings in its system already, if the agency wants to enforce, it will have to choose a sample of shops and enforce selectively, making examples of some offenders.

Whatever enforcement strategy the FDA is planning, it is planning something. The deeming regulations are still around, and vape businesses are expected to comply with them.

Here come the vape inspectors

An employment and training organization called AMTIS, Inc. says it has been contracted to inspect vaping manufacturing facilities by “a Federal agency that regulates tobacco products.” Only one federal agency does that.

The AMTIS recruiting ad explains the vape inspector job:

We have been contracted to conduct inspections of VAPE Manufacturers for a Federal agency that regulates tobacco products. The inspectors we hire for this project will perform non-confrontational inspections on local VAPE Manufacturers to inspect establishments engaged in the manufacture, assembly, preparation, compounding, processing, packing or repacking, labeling or relabeling, or holding of regulated tobacco products to document compliance with certain legislative provisions. The agency will utilize the information and evidence collected during inspections to document manufacturers’ compliance with all applicable requirements and to pursue enforcement actions. We are looking to hire flexible temporary, Part-Time to Full-Time Inspectors to conduct compliance check inspections on VAPE Manufacturers and to collect all data necessary to determine a retailer’s compliance with the applicable laws.

Required Qualifications:

  • Bachelor’s degree preferred, Associates of Arts (AA) degree is required preferably with 24 hours in criminology coursework OR 2 years of related experience in lieu of the education requirement.
  • Employment as a health, food, or drug officer or employee of any State, Territory, or political subdivision thereof (also known as “state and local officials” such as teachers, law enforcement officers, or firefighters) is required. Must possess excellent written and oral communication skills.
  • Skilled in observing places of business.
  • Experience in gathering and analyzing data.
  • Possess great attention to detail.
  • Skillful at using tools, equipment and systems to accomplish work.
  • Possess exceptional time management and organizational skills.
  • Must successfully complete a training session.
  • Able to obtain/maintain a Level 5 Public Trust clearance.
  • Able to obtain a commission.
  • Must not have a conflict of interest with the assigned manufacturers.

Preferred Qualifications:

  • Experience performing inspections and compliance checks preferred.

Essential Functions:

  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Travel to assigned locations according to schedule to complete compliance checks.
  • Perform regular inspections of tobacco (VAPE) retailers and complete compliance check inspection forms.
  • Identify and document relevant facts and findings needed to complete inspections assigned.
  • Perform interviews and inspections with key business officials in a professional manner.
  • Capture and collect high quality photographs of evidence pertaining to the requested information from the inspectional form to submit to FDA.
  • Provide accurate highly quality and timely reports on all inspections.
  • Prepare narrative report revealing potential compliance issues or violations.
  • Adhere to strict regulations regarding the performance of inspections.

Work Conditions:

  • Work is primarily performed in the manufacturer’s environment and within a home office setting for reporting purposes.

The original deadline for registering and product listing was last December. It has been postponed three times. Manufacturers that don’t know about the rules, or decide to purposely ignore them, won’t have a leg to stand when charged with not complying.

Clearly, the FDA Center for Tobacco Products is planning on enforcing its regulations. Will the small, independent vaping industry be prepared when the inspectors come knocking?

Jim McDonald
Smokers created vaping without any help from the tobacco industry or anti-smoking crusaders, and vapers have the right to keep innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I recently joined the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy