Judge Rules Against Graphic Cigarette Packs

District Court says FDA mandate would violate First Amendment.

Consumers may yet be spared graphic images of diseased lungs and smokers with holes in their throats, after R.J. Reynolds, Lorillard, and other tobacco companies prevailed over the Food and Drug Administration in the U.S. District Court for the District of Columbia today. Judge Richard Leon ruled that forcing cigarette manufacturers to offer their products only in gruesome packages was a violation of free speech, and therefore unconstitutional. The companies were granted a preliminary injunction, while the FDA regroups and lawyers rehuddle.

The judge wrote that “plaintiffs raise for the first time in our Circuit the question of whether the FDA's new and mandatory graphic images, when combined with certain textual warnings on cigarette packaging, are unconstitutional under the First Amendment. Upon review of the pleadings, the parties' supplemental pleadings, oral argument, the entire record, and the applicable law, the Court concludes that plaintiffs have demonstrated a substantial likelihood that they will prevail on the merits of their position that these mandatory graphic images unconstitutionally compel speech, and that they will suffer irreparable harm absent injunctive relief pending a judicial review of the constitutionality of the FDA's Rule.” (Complete ruling available here).

As Josh Gerstein reported at POLITICO, Leon “found that the new warnings, which occupy 50% of the front and back of cigarette packs, convert them into "mini-billboards...for [the FDA's] obvious anti-smoking agenda." Both Health and Human Services Secretary Kathleen Sebelius and FDA Commissioner Margaret Hamburg were also named in the lawsuit.

Judge Leon foresees a slippery constitutional slope if such mandates are allowed to bloom:

When one considers the logical extension of the Government's defense of its compelled graphic images to possible graphic labels that the Congress and the FDA might wish to someday impose on various food packages (i.e., fast food and snack food items) and alcoholic beverage containers (from beer cans to champagne bottles), it becomes clearer still that the public's interest in preserving its constitutional protections - and, indeed, the Government's concomitant interest in not violating the constitutional rights of its citizens - are best served by granting injunctive relief at this preliminary stage.

Graphics Credit: http://pubcit.typepad.com

To Flush or Not To Flush

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FDA lists meds for trash or toilet.

A recent post here on the subject of illegal bong water in Minnesota—coupled with a perceptive comment by a reader about drugs in the water supply—got me thinking again about what gets thrown in the sink or flushed down the toilet.

I was surprised to discover that, according to the Food and Drug Administration (FDA), consumers are better served by flushing some drugs down the toilet. The FDA has put up a web site dedicated to the proposition that flushing drugs is the preferred method for certain kinds of drugs—but not for every kind of drug.

While noting that “flushing is not recommended for the vast majority of medicines,” the FDA asserts at druginfo@fda.hhs.gov that “certain medicines may be especially harmful and, in some cases, fatal in a single dose...” To dangerous, in other words, to leave around the house or in the trash.

The potential for fatal overdose, particularly with prescription morphine and its derivatives, suggests that flushing will be the preferred method of disposal unless or until communities and pharmaceutical companies get serious about take-back programs and other medicine disposal services.

Specifically, drugs recommended for flushing include:

--Morphine Sulfate (Morphine, Avinza, Embeda, Kadian, MS Contin, and Oramorph).

--Fentanyl Citrate (Actiq, Duragesic, Fentora, Onsolis).

--Meperidine Hydrochloride (Demerol).

--Methylphenidate (Daytrana).

--Hydromorphone Hydrochloride (Dilaudid).

--Methadone Hydrochloride (Methadone, Methadose, Dolophine).

--Oxymorphone Hydrochloride (Opana).

--Oxycodone Hydrochloride (Oxycontin, Percocet, Percodan).

-- Sodium Oxybate (Xyrem).

The FDA says that the disposal of “these select, few medicines by flushing contributes only a small fraction of the total amount of medicine found in the water. FDA believes that any potential risk to people and the environment from flushing this small, select list of medicines is outweighed by the real possibility of life-threatening risks from accidental ingestion of these medicines.”

The preferred disposal method for all other drugs, says the FDA, is to mix them with kitty litter or coffee grounds, place the mixture in a sealed plastic bag, and throw the container in your household trash.

Photo Credit: www.pri.org

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FDA Bans Flavored Cigarettes

An unintentional boost for cigar sales?

When is a cigar more than just a cigar? When its appearance allows it to circumvent the intent of the Food and Drug Administration’s first ruling related to cigarettes, that’s when.

In its first official ruling since Congress passed legislation giving the agency authority to regulate tobacco (see my earlier post), the FDA banned so-called flavored cigarettes. Cigarette makers can no longer add vanilla, clove, chocolate, or any other fruit or candy flavors to their product. Menthol, for now, is exempt from the ban.

FDA commissioner Margaret Hamburg said that 90 percent of adults who smoke began doing so as children. The president of the Campaign for Tobacco-free Kids agreed, calling flavored cigarettes “starter products” for young smokers in a Dow Jones Newswires report by Jennifer Corbett Dooren.

By law, the agency cannot ban regular cigarettes outright. However, as Gardiner Harris reported in the September 23 New York Times, “the legislation left some details vague. For instance, the agency is required to ban flavored cigarettes, but the law did not clearly define what constituted a cigarette."

Huh? As it turns out, a cigarette is in the mind of the beholder. The FDA maintains that the ban applies to all cigarette-type tobacco products, including those that are “labeled as cigars or as some other product.” A spokesperson for the Campaign for Tobacco-Free Kids agreed: “The FDA demonstrated that they’re serious about enforcing the ban on flavored cigarettes, and serious about preventing tobacco companies from circumventing that ban,” according to the New York Times article.

Not so fast, argued Norman Sharp, president of the Cigar Association of America. Sharp told the Times that the ban clearly did not apply to cigars: “We feel this should go a long way to clearing up any confusion in the marketplace.”

Well, not exactly. An exasperated spokesperson for cigarette maker R.J. Reynolds, also quoted in the article, said: “It’s hard to understand. We need clear and timely guidance so all of us can work together so that we can understand what we need to be doing.”

What about the small brown cigarillos sold by an R.J. Reynolds subsidiary?

“They are not cigarettes,” the spokesperson said.


Photo Credit: http://politics.mync.com/tag/cigarette/

addiction drugs smoking nicotine

House Tobacco Bill Moves to Senate

Bill would give FDA control over nicotine products.

It is one of the most popular drugs in America, used and abused by millions. Yet it is not regulated by any government agency. There is no federal testing, no quality control, no standards of any kind. As representative Jared Polis (D-Colorado) memorably told the U.S. House of Representatives: “Tobacco use is the single largest cause of preventable death in our country. Yet it continues to receive less regulation than a head of lettuce.”

That deplorable situation may soon change, as the U.S. Senate takes up a bill recently passed by the House. The legislation would give the Food and Drug Administration (FDA) broad new powers to regulate the tobacco industry for the first time in history.

The house bill is similar to one passed last session, which died in the Senate after it was opposed by the Bush administration. According to reports by Duff Wilson in the New York Times, the legislation would enable the FDA to “approve or reject current and proposed tobacco products and ingredients, based on scientific and health findings.” The FDA would be able to restrict harmful chemicals and reject new tobacco products, but in a major concession to Philip Morris, the nation’s largest cigarette maker, the bill “would not allow a complete ban of tobacco products, or permit the agency to order the complete removal of nicotine.” The Times article also said the bill would lead to larger and more graphic warning labels on cigarette packs.

Senator Edward Kennedy (D-Massachusetts) said he plans to introduce the bill later this month. The legislation is supported by President Obama. An official statement released by the administration said that tobacco use “is a major factor driving the increasing costs of health care in the U.S. and accounts for over a hundred billion dollars annually in financial costs to the economy.” Attempts to mandate FDA regulation of tobacco have been made repeatedly over the past decade.

Tobacco industry supporters have vowed to fight the bill on the Senate floor. Senator Richard Burr (R-North Carolina) said he was considering a filibuster. House Republican Virginia Foxx, also of North Carolina, derided the legislation as “an unnecessary and expensive regulatory scheme at the expense of our rural farming communities.” North Carolina is the country’s leading tobacco growing state.

A spokesperson for the American Heart Association said the Senate was expected to act quickly on the bill: “This has certainly been a passion of Senator Kennedy’s and a legacy he can leave to the public health of America.”

Photo Credit: Winston-Salem Journal

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