Wednesday, September 28, 2016

FDA Issues New Draft Guidance on Regulation Compliance for Certain Types of E-Cigarettes; CDC Comments

The FDA took steps yesterday to clear a big point of confusion that has arisen concerning a subset of electronic cigarettes on the market. Due to novel technology that allows nicotine to be extracted in concentrated form from potatoes, a number of e-cigarette companies have switched to using potatoes as a source of nicotine for their e-liquids. Several companies have asked the FDA's Center for Tobacco Products for guidance on whether they need to comply with the tobacco product regulations, since their products do not contain tobacco and the nicotine used is not derived from tobacco.

Here is the relevant excerpt from the FDA's guidance document which explains how these products will be treated by the agency:

On May 10, 2016, the agency published a final rule that deems all products meeting the statutory definition of “tobacco product,” except accessories of the newly deemed tobacco products, to be subject to FDA's tobacco product authorities under chapter IX of the FD&C Act. Section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), as amended by the Tobacco Control Act, defines the term “tobacco product,” to mean “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)” and does not mean “an article that is a drug under subsection (g)(1), a device under subsection (b), or a combination product described in section 353(g) of this title.”

Products that contain nicotine derived from tobacco meet the definition of a tobacco product under the FD&C Act and are required to bear a health warning on packages and in advertisements stating: “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” For products that are made or derived from tobacco (but do not contain nicotine), manufacturers may submit a certification to FDA and, instead, bear the statement “This product is made from tobacco.”

The definition of “tobacco product” as set forth in section 201(rr) of the FD&C Act includes all components, parts, and accessories of tobacco products (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). FDA interprets components and parts of a tobacco product to include any assembly of materials intended or reasonably expected: (1) To alter or affect the tobacco product's performance, composition, constituents or characteristics; or (2) to be used with or for the human consumption of a tobacco product. E-liquids that do not contain nicotine or other substances derived from tobacco may still be components or parts and, therefore, subject to FDA's tobacco control authorities, if they are an assembly of materials intended or reasonably expected to be used with or for the human consumption of a tobacco product and do not meet the definition of accessory.

E-liquids that contain nicotine derived from potatoes do not meet the statutory definition of "tobacco product" unless they are reasonably expected to be combined with a tobacco product. However, since e-liquids that contain nicotine derived from potatoes are "potato products," the agency declares that such products must comply with Marketing Order No. 946, as amended (7 CFR part 946), regulating the handling of potatoes, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”  

Under the order, regulated potatoes must be inspected and certified by FSIS. As authorized under the order, the Committee uses information included on FSIS inspection certificates as a basis for collecting assessments and compiling industry statistics. The order requires handlers to submit reports to provide information on the volume of red types of potatoes handled for the fresh market. The order includes handling regulations for all varieties or varietal types of potatoes grown in the production area. These regulations can include minimum grade, size, quality, maturity, and inspection requirements. They can also provide for the size, capacity, weight, dimensions, pack, marking, or labeling of containers used in the handling of such potatoes. 

Because the agency has deemed e-liquids using nicotine derived from potatoes to be "potato products," these e-liquids and any vaping devices intended for use with these e-liquids are subject to inspection and certification by FSIS. These e-cigarette manufacturers must also submit reports to provide information on the volume of red potatoes handled for the fresh market. They must also comply with the handling regulations for all varieties or varietal types of potatoes grown in the production area.

The Rest of the Story

I have to give the FDA credit for at least following its own logic. If e-liquids that use nicotine derived from tobacco are "tobacco products," then e-liquids using nicotine derived from potatoes are "potato products," and their manufacturers should be subject to all regulations for potatoes, including handling, inspection, packaging, labeling, and production requirements. However, I have to question why the agency ignored the recent emergence of companies that are using nicotine derived from eggplants to prepare e-liquids. Clearly, these products should be deemed "eggplant products" and should be required to comply with all USDA regulations governing the production, inspection, and labeling of eggplants.

Understandably, many small business owners who are in the e-liquid potato nicotine extraction business were upset. The president of NicoSpud E-Liquids was quoted as saying: "These regulations are going to decimate the potato nicotine extraction business. As a small company, we cannot afford the expense of complying with the detailed reporting, inspection, packaging, and labeling requirements. The FDA has basically handed the entire market over to Big Potato." Indeed, the two largest potato manufacturers have each put their own brand of potato-derived e-cigarettes on the market. The R.D. Offutt Company is now selling its "E-Tater" brand in major convenience stores across the country. J.R. Simplot is test-marketing its "SafeSpuds" in Colorado and Utah.

But the national anti-vaping groups defended the FDA's action. According to the Campaign for Tobacco-Free Kids: "Following the playbook of Big Tobacco, e-cigarette companies are using sweet flavors to entice kids to what could turn into a lifetime addiction to nicotine." The Campaign called out "Sweet Potate," a Tampa-based company, for using the word "sweet" in the very name of the product (Sweet Potate Cigs).

The CDC also supported the new guidance, saying: "The use of nicotine in any form is hazardous and can cause impaired brain development in adolescence. The great gains we have seen over the past decades in reducing youth smoking are sadly being undermined by their increased use of potato products."

The CDC, in classifying e-cigarettes using nicotine derived from potatoes as "potato products," has recently documented a large increase in youth potato use. While actual youth consumption of potatoes has fallen significantly, overall potato use among high school students has increased over the past two years.

I do not understand why the FDA and CDC need to lie about these e-cigarettes. They are not potato products simply because the nicotine in their e-liquids happens to be derived from potatoes. And classifying the use of these e-cigarettes as "potato use" is disingenuous at best. Why do we need to lie in order to make our point? Wouldn't it be enough to tell kids that these products are not made from potatoes and therefore do not carry the same safety profile as potatoes. Already, there is evidence of widespread public confusion. More than 50% of youth surveyed believe that e-cigarette use is no more hazardous than eating candied yams.

The rest of the story is that by treating e-cigarettes like NicoSpud, SafeSpud, and SweetPotate exactly like potato products and by classifying them as potato products, the FDA and CDC are essentially telling the public, including our children, that the hazards of vaping these products are virtually identical to those of consuming potatoes.

What will it take for these agencies to understand that just because the nicotine in the latest generation of e-cigarettes happens to be derived from potatoes, that does not mean they are potato products? It is misleading if not outright dishonest to talk about these e-cigarettes as "potato products," to classify them as potato products in surveys, and to claim that youth who are using these products are engaging in potato use.

ADDENDUM: It has come to my attention that many readers did not realize that this is a parody  – my attempt at satire. It is a sad state of affairs that the FDA’s logic has been so terrible that my readers don’t know if this is true or not. That was my exact point in doing this piece. I wanted to show the absurdity of the FDA’s approach – and I think this analogy points it out in a way that many anti-vaping organizations would not understand in any other way. If there is any doubt about whether the deeming regulations are "arbitrary and capricious," this is the proof.

No comments: