FDA to decide on relaxing merchandising restrictions for Plan B
WASHINGTON — The Food and Drug Administration will decide on Wednesday whether to remove merchandising restrictions on the emergency contraceptive Plan B and allow the product to be merchandised in the front-end without age restrictions, according to a report published Monday in the Washington Post.
According to the report, Teva Pharmaceutical Industries requested that the FDA relax merchandising restrictions based on two new consumer usage studies showing that pre-teen and teenage women appropriately self-selected use of the emergency contraceptive. One study involving 335 girls ages 12 to 17 years showed that between 72% and 96% of them understood the proposed package label well enough to use the drug safely and effectively on their own. The second study, involving about 300 girls ages 11 to 16 years, showed that they could use the product properly and safely, according to Teva.
Separately, a hearing is scheduled for Dec. 13 on a motion to declare the agency in contempt of court for failing to review its decision to leave age restrictions in place as part of a suit filed against the agency by the Center for Reproductive Rights.
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FDA, FTC issue seven warning letters to companies promoting OTC HCG products
SILVER SPRING, Md. — The Food and Drug Administration and the Federal Trade Commission on Tuesday issued seven warning letters to companies marketing over-the counter human chorionic gonadotropin products that are labeled as "homeopathic" for weight loss. The letters warn the companies that they are violating federal law by selling drugs that have not been approved and by making unsupported claims for the substances. There are no FDA-approved HCG drug products for weight loss.
HCG is a hormone produced by the human placenta and found in the urine of pregnant women. HCG is FDA-approved as an injectable prescription drug for the treatment of some cases of female infertility and other medical conditions. The FDA produced a video, featuring Elizabeth Miller — pharmacist and acting director of FDA’s Division of Non-Prescription Drugs and Health Fraud — warning consumers of the consequences of taking HCG and following the recommended 500-calorie-a-day diet. To view that video, click here.
The joint action is the first step in keeping the unproven and potentially unsafe products from being marketed online and in retail outlets as oral drops, pellets and sprays.
The labeling for the "homeopathic" HCG products states that each product should be taken in conjunction with a very low calorie diet. There is no substantial evidence HCG increases weight loss beyond that resulting from the recommended caloric restriction. Consumers on a very low-calorie diet are at increased risk for side effects, including gallstone formation, electrolyte imbalance and heart arrhythmias.
"These HCG products marketed over-the-counter are unproven to help with weight loss and are potentially dangerous even if taken as directed," stated Ilisa Bernstein, acting director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research. "And a very low calorie diet should only be used under proper medical supervision."
"Deceptive advertising about weight-loss products is one of the most prevalent types of fraud," added David Vladeck, director of the FTC’s Bureau of Consumer Protection. "Any advertiser who makes health claims about a product is required by federal law to back them up with competent and reliable scientific evidence, so consumers have the accurate information they need to make good decisions."
According to the warning letters, the companies have 15 days to notify the FDA of the steps they have taken to correct the violations cited. Failure to do so may result in legal action, including seizure and injunction or criminal prosecution.
Nearly 3-in-4 parents want to breast-feed as long as they are able
ANDOVER, Mass. — As many as 95% of women reported having at least attempted to breast-feed their babies, with 35% continuing between four and six months, and another 52% breast-feeding for seven to 12 months, according to the Philips Mother & Child Care Index that was released Monday by the Philips Center for Health and Well-being.
And parents would like to breast-feed even more — 72% expressed a desire to continue breast-feeding as long as possible. The survey cited pain and lack of milk supply as the two top reasons women give-up on breast-feeding, and a return to the workplace also contributed to their decision to stop breast-feeding.
“The findings show that parents are placing a very high value on breastfeeding,” stated Katy Hartley, director for the Philips Center for Health and Well-being. “There is an opportunity to help parents who want to breastfeed their children for longer than six months, but lack the resources to help cope with problems that may arise.”
Pain was usually a factor that caused women to stop breast-feeding within the first three months, and lack of supply typically caused women to stop between three and seven months. As many as 67% of American women cited a lack of milk supply as a reason, compared with 40% globally. And 73% of American women completed a breast-feeding course, compared with 41% of mothers globally.
“Parents’ commitment to breast-feeding should be bolstered by a recent IRS ruling that expenses paid for breast pumps are deductible medical expenses under IRS Section 213(d),” Philips AVENT marketing director Ron Tiktin said. “As a result, expenses for these items may now be reimbursed by flexible spending arrangements, health reimbursement arrangements and health savings accounts.”
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