Current Good Manufacturing Practices “cGMP” and E-Cigarettes / E-Liquids
Current Good Manufacturing Practices “cGMP” and E-Cigarettes / E-Liquids
cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). FDA has published cGMPs, for various products, including medical devices, drugs and food products. These require companies to put systems to ensure sufficient product design and control. Existing cGMP regulations are intentionally ambiguous to allow flexibility in implementation. FDA largely leaves it up to manufacturers to “fill in the blanks” for the detailed requirements in company standard operating procedures (SOP).
However, with regard to e-cigarettes/e-liquids, FDA states it must “first promulgate through rulemaking good manufacturing practice requirements applicable to tobacco products (or Tobacco Product Manufacturing Practice). Once these requirements are in effect, they will apply to newly deemed tobacco products.” As of the date of this blog, no such requirements are in effect.
While the FDA has not yet established GMP regulations for tobacco products, the agency can rely on existing statutes, such as the FDCA [Food, Drug and Cosmetic Act], to prohibit adulterated and misbranded products from entering interstate commerce. Particularly, section 906(e) of the TCA [Tobacco Control Act] provides in relevant part as follows: “In applying manufacturing restrictions to tobacco, the secretary shall, in accordance with subparagraph (B), prescribe regulations (which may differ based on the type of tobacco product involved) requiring that the methods used in, and the facilities and controls used for, the manufacture, preproduction design validation (including a process to assess the performance of a tobacco product), packing and storage of a tobacco product conform to current good manufacturing practice or hazard analysis and critical control point methodology, as prescribed in such regulations to assure that the public health is protected and that the tobacco product is in compliance with this chapter. …”.
Further, as manufacturers are preparing their Pre-Market Tobacco Application, you will note that very detailed information on manufacturing is sought. Including, “a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packaging of the new tobacco product, including e-liquids and aerosolizing apparatus.” This includes SOP’s, for all aspects of manufacturing, including, but is not limited to: production control, management responsibility, training, formulations processes, supplier selection and monitoring, purchasing controls and a variety of others.
The e-cig/e-liquid attorneys at Brown & Charbonneau, LLP are up to date on all issues affecting the industry,including FDA manufacturing requirements, and are prepared to assist you. To learn more, call us today at 714.406.4397 to set up a consultation. For more information about the e-cigarette, e-liquid and ENDS industry, please click here