At yesterday’s meeting with the U.S. House Subcommittee on Agriculture and Rural Development to discuss FDA’s Fiscal Year 2019 budget, Food and Drug Administration (FDA) Commissioner Scott Gottlieb discussed the Agency’s regulation of the tobacco industry and noted, among other things, that when all the requirements for the newly deemed products, including vapor products, went into effect last year, FDA now has authority to inspect and impose GMP standards and enforce age restrictions. Gottlieb indicated that FDA would be “stepping into this fight in a vigorous way in the coming weeks.”
Being prepared for an FDA inspection is critical to maintaining compliance. Just a few weeks ago, FDA’s recently-issued Request for Proposal (RFP), Vape Inspection Services (FDA-RFP-18-1190619), was extended on March 22, 2018 to allow for additional time for FDA to receive, review and consider responses from government contractors submitting bids to conduct inspections of establishments engaged in the retail sale of FDA-regulated tobacco products.
The RFP provides valuable insight into the Agency’s current thinking with regard to the scope of inspections that are expected to begin shortly, as mandated by the Tobacco Control Act.
Specifically, the RFP indicates that the contractor(s) shall, in the course of a facility inspection:
- Complete and provide FDA with a signed Form FDA 482 (“Notice of Inspection”);
- Complete an inspection form, detailing:
- Administrative information;
- The scope of the facility’s business (e.g., manufacturing, retail, import/export of products);
- A list of potential violations of the Federal Food, Drug, and Cosmetic Act; and
- Be prepared to testify on behalf of FDA in any regulatory or judicial proceeding.
The RFP focuses extensively on the type of evidence collection and storage permissible under the Agency’s guidelines – including the collection of photographic and physical evidence. The RFP further requires that the contractor complete required Agency training regarding the permissibility of collecting reports, data, documents, and photos (including limitations on Confidential Business Information (CBI), sales data, and personnel data).
The RFP describes the scheduling of inspections on a continuing, quarterly basis, in accordance with designated quotas. The program allocates funding for one full-time program manager, approximately 10 program coordinators, and 20 inspectors (based on 2,080 annual hours per full-time equivalent).
Keller and Heckman continues to monitor developments relating to FDA’s forthcoming inspections of tobacco and vapor manufacturing establishments, and, to help companies prepare, recently launched the Audit and Inspection Program (AIP). The AIP provides establishments with an opportunity to conduct advance, client-confidential, independent auditing to identify and remedy any deficiencies. In addition, the AIP provides establishments with training regarding FDA’s inspection authority, the permissibility of Agency collection of business information, and optional environmental and occupational health and safety components. For additional details on the AIP Program and to register, click here.
On May 2, 2018 (3:00 PM ET), attorneys Azim Chowdhury and Daniel Rubenstein will be participating in a free webinar hosted by the Smoke-Free Alternatives Trade Association (SFATA), “The FDA is Coming – Are You Ready” and will be discussing Keller and Heckman’s AIP and how manufacturers and retailers can prepare for an FDA inspection. Register for the webinar here.