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This Week in FDA Regulations: Roll-Your-Own, Trans Fat, Cosmetics

By William Peacock, Esq. on August 15, 2013 | Last updated on March 21, 2019

Here are a few good questions: What's the difference between filtered cigarillos and cigarettes? How about pipe tobacco and roll-your-own cigarette tobacco? And why are cigarettes, cigarillos, cigars, and pipe tobacco all regulated differently?

If the lines between types of tobacco are blurry, then the regulations are even more so, though the FDA is stepping up their enforcement. Meantime, someone is suing the FDA for not regulating, specifically their inaction towards trans fat. And in another area of nonregulation, the FDA has issued "guidance," rather than binding regulations, on cosmetics.

Read on for the regulation roundup:

Roll It, Pipe It, Puff It

Back in 2009, the government tweaked the rules on roll-your-own tobacco in order to put it on even ground with manufactured cigarettes, tax and regulation-wise. In response, sales of RYO tobacco dropped by more than 76 percent in 2011, while "pipe tobacco" sales increased by 573 percent, according to Tobacco-Free Kids.

Are pipes becoming trendy among hipsters who can't afford a pack of Marlboros? We certainly haven't seen them being pulled out at our local watering holes, and per Tobacco-Free Kids, there is no evidence of any increase in actual pipe smoking.

Instead, a series of letters sent out by the FDA, including this one, seem to point to a different culprit: Roll-your-own tobacco is being relabeled as pipe tobacco, while the promotion and packaging strongly suggests that it is to be used for RYO purposes.

Clever. And it saved the manufacturers from paying $1.3 billion in taxes from April 2009 to August 2011, according to CDC estimates. We'll see how long this loophole lasts, especially now that the FDA has caught on.

Ban Trans Fat

We're all pretty sure that trans (partially hydrogenated) fats are bad for you. After a bit of an uproar about it a few years ago, we noticed many fast food eateries touting "Trans Fat Free!" signs (which may have been less than truthful). That doesn't mean the grease, which is allegedly linked to heart disease, Type 2 diabetes, and other ailments, has completely disappeared.

If Fred Kummerow has his way, it will. The 98-year-old researcher, who has studied heart disease for more than 60 years, petitioned the FDA to ban trans fats in 2009.

Since then, they've done, well, nothing. They haven't even issued a final response to his petition. He's kept quite busy, however, and has now filed a lawsuit to compel action and a response, reports Courthouse News Service. Here's hoping he succeeds. New York City's 2006 ban has worked out quite nicely, according to Time.

Makeup... Unregulated

You'd think, with people plastering chemical-laden substances all over their faces, lips, and eyelids, that cosmetics would be a heavily-regulated area. It is now, at least in Europe. New regulations just took effect in the EU that requires the appointment of an EU compliance "operator," as well a mandate that "good manufacturing practices" (GMPs) are followed.

Packaging Materials notes that while most major manufacturers voluntarily comply with GMPs, there is no such mandate here in the States. Instead, the FDA has recently issued draft guidelines that suggest that companies use GMPs. Existing binding regulations are minimal, banning only a few ingredients, such as chloroform and mercury.

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