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.”
To download the complete report, click here.
Healthcare scorecard: The bad offsets the good
MINNETONKA, Minn. — United Health Foundation’s "2011 America’s Heath Rankings," released Tuesday, found that increases in obesity, diabetes and children in poverty are offsetting improvements in smoking cessation, preventable hospitalizations and cardiovascular deaths. According to the report, the country’s overall health did not improve between 2010 and 2011 — a drop from the 0.5% average annual rate of improvement between 2000 and 2010, and the 1.6% average annual rate of improvement seen in the 1990s.
“Where people live matters. Every state can make improvements to ensure healthier quality of lives for their residents,” stated Reed Tuckson, United Health Foundation board member and EVP and chief of medical affairs for the UnitedHealth Group. “In the history of the rankings, we have seen many examples of stakeholders coming together to improve their standing. States, such as Tennessee and Maine — which made explicit efforts to improve their rankings — have shown us that improved public health is achievable but must be tackled in a concerted and aggressive way.”
For the fifth year in a row, Vermont is the nation’s healthiest state. States that showed the most substantial improvement include New York and New Jersey, both moving up six places, largely because of improvements made in smoking cessation. Idaho and Alaska showed the most downward movement. Idaho dropped 10 spots, from number nine to 19 in this year’s rankings, and Alaska dropped five places.
To see the rankings in full, click here.
This year’s rankings, which offers a state-by-state snapshot of population health based on 23 measures, includes several positive nationwide trends:
Smoking cessation: 17.3% of the population smoked in 2011, down from 17.9% in 2010 — a 3.4% decline since 2010; a 25.4% decline since 2001;
Preventable hospitalizations: 68.2 preventable hospitalizations per 1,000 Medicare enrollees in 2011, down from 70.6 preventable hospitalizations in 2010 — a 3.4% decline since 2010; a 17.3% decline since 2001; and
Cardiovascular deaths: 270.4 deaths per 100,000 in 2011, down from 278.2 deaths per 100,000 in 2010 — a 2.8% decline since 2010; a 22.2% decline since 2001.
These improvements were offset by increases in:
Obesity: 27.5% of the adult population in 2011, up from 26.9% of the adult population in 2010 — a 2.2% increase since 2010; a 37.5% increase since 2001. 2011 marks the first year when no state had an obesity prevalence under 20%;
Diabetes: 8.7% in 2011, up from 8.3% in 2010 — a 4.8% increase since 2010; a 42.6% increase since 2001; and
Children in poverty: 21.5% in 2011, up from 20.7% in 2010 — a 3.9% increase since 2010; a 33.5% increase since 2001.
The fact that the country did not improve in overall health status means there was a balance between improvements and detriments across all 23 measures. A compelling example of this stagnation is the improvement in the number of smokers being offset by worsening rates of obesity: the rankings found that, for every person who quit smoking in 2011, another person became obese. And a 2010 report from the UnitedHealth Center for Health Reform & Modernization indicated that if current trends continue, diabetes and prediabetes will account for approximately 10% of total healthcare spending by 2020 at an annual cost of almost $500 billion — up from an estimated $208 billion this year.
“While this year’s rankings shows some important improvements, we also see some very alarming trends — particularly diabetes and obesity — that, left unchecked, will put further strain on our country’s already strained health care resources,” Tuckson said. “At a time when the nation, states and individual families are grappling with tightening budgets and growing healthcare expenses, this year’s rankings sends a loud wakeup call that the burden of preventable chronic disease will continue to get worse unless we take urgent action."
In conjunction with the report, United Health Foundation is launching an interactive “Take Action for Change” campaign to incent Americans to adopt healthier habits. “Take Action for Change” is designed to inspire people to adopt healthier behaviors. For every day someone pledges an “act of health” on the America’s Health Rankings Facebook page, United Health Foundation will make a 25 cent donation — up to a total of $50,000 — to nonprofit organizations dedicated to improving the nation’s health.
Visitors to the Facebook page will be able to upload their own “acts of health” and vote for which nonprofit organization will receive the donation.
The American Cancer Society, Campaign for Tobacco-Free Kids and YMCA are partnering with United Health Foundation on this initiative.