FDA

New regulations for e-cigarettes are likely to have a large impact on the industry, experts say. The rules could force many small e-cigarette businesses to close, while benefitting large tobacco companies.

The three largest U.S. tobacco companies this week announced they will drop their lawsuit against the Food and Drug Administration, after the agency said it would reconsider rules about the companies’ product labels.

The Food and Drug Administration this week denied a request from two subsidiaries of the tobacco company Reynolds American to change the warning label of smokeless tobacco products to indicate they are less risky than traditional cigarettes.

The Food and Drug Administration has warned the makers of eight dietary supplements that their products contain a potentially dangerous stimulant called BMPEA, The New York Times reports.

The American College of Physicians this week urged the Food and Drug Administration (FDA) to ban flavorings and television ads for e-cigarettes. The group joins many other medical organizations, including the American Medical Association and the American Heart Association, in calling on the FDA to regulate e-cigarettes.

The three largest tobacco companies are suing the Food and Drug Administration (FDA), claiming new guidelines issued by the agency infringe on their commercial speech. The new guidelines are designed to help manufacturers decide which new products require FDA review.

U.S. Senator Charles Schumer of New York is urging the Food and Drug Administration to ban over-the-counter dietary supplements that contain the stimulant beta-methylphenethylamine, or BMPEA. The stimulant, often marketed as a weight-loss aid, can lead to serious health problems, doctors say.

At a Food and Drug Administration hearing this week to consider whether the smokeless tobacco known as “snus” is less harmful than cigarettes, government scientists questioned a proposal to modify cancer warning language on the product’s packaging.

The Food and Drug Administration this week issued guidelines for drug manufacturers on developing opioid painkillers that are more difficult to abuse. The guidelines recommend the types of studies needed to prove drugs can deter abuse, The Wall Street Journal reports.

Although alcohol in powdered form has been around for decades – long before a 1976 patent for it was issued to the General Foods Corporation – the announcement of a new product tabbed for the market has pushed the topic back to the forefront.

The Food and Drug Administration will consider this spring whether the smokeless tobacco known as snus is less harmful than cigarettes.

Drugs to treat alcoholism would not have to lead to sobriety in order to be approved by the Food and Drug Administration, under a proposal by the agency. Instead, drug companies could gain approval for treatments if they prove patients using them no longer drink heavily.

Two organizations representing cancer researchers and specialists are calling on the Food and Drug Administration to bring e-cigarette regulations more in line with those of traditional cigarettes.

The Food and Drug Administration has issued a warning about powdered pure caffeine, following the deaths of at least two young men who used the product.

A Food and Drug Administration hearing last week revealed there are a number of disagreements among experts about abuse-deterrent opioids, MedPageToday reports.

The Food and Drug Administration has approved new labeling for the opioid painkiller Embeda that states the drug has abuse-deterrent features, the Associated Press reports.

After a group of activists called on the head of the Food and Drug Administration (FDA) to quit over the approval of the painkiller Zohydro, three FDA officials say the drug’s approval was warranted.

A group of activists says the Food and Drug Administration has worsened the opioid overdose epidemic. They are calling on the head of the agency, Commissioner Margaret A. Hamburg, to quit, The Washington Post reports.

A group of 29 state attorneys general urged the Food and Drug Administration to impose restrictions on e-cigarettes, according to The Wall Street Journal. They are asking for a ban on television ads and on candy and fruit flavors.

New federal tobacco regulations contain a cost-benefit calculation known as the “happiness quotient,” which weighs the health benefits of reduced smoking against the loss in pleasure that smokers suffer when they quit. This calculation could make it harder for the Food and Drug Administration to take strong action against tobacco companies, critics say.

More prescription drugs have received black-box safety warnings since a law designed to speed the drug approval process was passed in 1992, according to a new study.

A new painkiller that combines oxycodone and naloxone was approved by the U.S. Food and Drug Administration on Wednesday. Naloxone was included in the drug to block the euphoric effects of oxycodone, making it less appealing to abuse.

A federal judge ruled this week that the Food and Drug Administration cannot use findings from a panel report that recommended removing menthol cigarettes from the market. Three of the panel members had conflicts of interest, the judge said.

Studies used to approve drugs to treat attention-deficit hyperactivity disorder (ADHD) did not address long-term safety, according to new research.

The consumer advocacy group Center for Science in the Public Interest is urging the Food and Drug Administration to put safety warnings on energy drinks, according to Reuters. The drinks have been linked to 17 deaths in the past two years.