The
CDC study, published as
a letter Wednesday in the Journal of the American Medical Association, looked at trans fat levels in people before and after the
2006 Food and Drug Administration mandate requiring trans fat amounts to be listed on Nutrition Facts food labels.
Even before that rule was imposed, the prospect of FDA action and heightened publicity about the risk of heart disease from trans fat spurred a switch to healthier oils. The CDC study sought to determine the effect of government regulation and those other moves.
Christopher Portier, director of CDC?s National Center for Environmental Health said all the efforts were effective "in reducing blood TFAs (trans fatty acids) and highlight that further reductions in the levels of trans fats must remain an important public health goal."
"Credit for the reductions in trans fat is shared by many parties," noted a news release from Michael Jacobson of the Center for Science in the Public Interest. CSPI has petitioned the FDA over trans fat, and also sued restaurants chains that were frying foods in partially hydrogenated oil. "New York, Philadelphia, Baltimore, California, Montgomery County, MD, and other jurisdictions banned most artificial trans fat from restaurant food.
"The FDA helped greatly by requiring that trans fat be listed on Nutrition Facts labels. And oil processors, seed developers, and farmers worked hard to produce and market healthier oils for restaurants and food manufacturers to use," said Jacobson, adding that the dramatic drop in trans fat levels in people "represents enormous public health progress and is almost certainly preventing thousands of heart attacks and premature deaths each year."
CSPI says more must be done. In urging the FDA to ban partially hydrogenated oil -- a major source of trans fat -- it has
highlighted the foods still loaded with trans fat. It observes that the U.S. Department of Agriculture, which has jurisdiction over foods with meat or poultry such as pot pies, has not adopted the FDA's trans fat labeling rule.
Unlike other dietary fats, trans fats are not essential to human health and do not promote good health. High consumption of trans-fatty acids is linked to cardiovascular disease in part because TFAs increase LDL cholesterol ("bad" cholesterol), the CDC says. Changing to a diet low in TFAs may lower LDL cholesterol levels, thus decreasing the risk for cardiovascular disease.
To avoid trans fat in one's diet, the CDC recommends:
- Looking for the trans fat listing on the Nutrition Facts label. Comparing brands and choosing the one lowest in trans fat, preferably with no trans fat. - Replacing margarine containing trans fat with unsaturated vegetable oil. - If you use margarine, choose a soft margarine spread instead of stick margarine. Check your labels to be sure the soft margarine does contain less trans fat. If possible, find one that says zero grams of trans fat.
While the current study looked only at white adults, CDC researchers are also looking at blood TFAs in other adult race/ethnic groups, children and adolescents, Portier said. The trans fat research is a part of a larger
National Biomonitoring program, which measures more than 450 environmental chemicals and nutritional indicators in people.
http://www.sciencedirect.com/science/journal/17406773
Drug Discovery Today: Therapeutic Strategies, Volume 8, Issues 3–4, Pages 57-144 (Winter 2011)
Edited by Christopher A. Lipinski
An article appearing in Drug Discovery Today: Therapeutic Strategies examines the landscape of drug repurposing. Repurposing refers to the process of taking existing or abandoned molecules and assigning new indications to them. This practice is not designed to replace drug discovery and development but rather to complement existing regulations facilitating orphan drug development as another strategy for increasing the number of available products to treat rare diseases. Besides the obvious benefits to the patient and healthcare provider a larger arsenal of treatment offers, the authors point out the benefits to the sponsor of repurposing existing molecules: "The traditional methods for drug discovery require a large infrastructure while repurposing FDA-approved drugs is relatively inexpensive; repositioning is especially valuable for smaller companies. With repurposed drugs, developers can bypass almost half of the overall cost by eliminating preclinical assessment. Venture capitalists prefer the repositioning over investing in technology platforms".
Rules for
Senate Bill (SB) 81, which went into effect last Sept. 1, were not made public until Dec. 1 at a meeting of the Texas State Health Services Council.
At issue are labeling requirements for food items prepared by home kitchen retailers. The rules call for the burgeoning
cottage food industry in Texas to list the ingredients on the label for each product they sell. Home bakers think that requirement is ridiculous.
Rep. Lois Kolkhorst, chair of the Texas House Committee on Public Health, says the rules are "are a shining example of overreach." Her staff is telling Texas media that major food retailers have been at work influencing the rule-makers in the Texas Department of Health.
And the cottage food industry is saying it is being subjected to requirements stricter than commercial bakeries and restaurants have to follow. Kelly Masters, spokeswoman for the home kitchen bakers, asks how often Starbucks has to list the ingredients on labels for its bakery items.
As signed by Texas Gov. Rick Perry last June, SB 81 does include some labeling requirements. Specifically, the law says labels on retail goods produced in a home kitchen must include the name and address of the food producer and state that the products were made in an uninspected and unlicensed home kitchen.
However, other details were left up to the rule-making process.
SB 81 was a little more complicated than most cottage-food bills introduced and in some cases approved around the country. The Texas measure also set out to put fresh produce wholesalers under state regulation for the first time. When Gov. Perry signed the bill, the harvest, packaging, washing and shipping of all raw produce was put under a state inspection regime. Texas lawmakers were moved by reports of recent contamination and outbreaks involving produce such as tomatoes, spinach, and peppers, which previously had been viewed as too low-risk to merit state attention.
While SB 81 does not require a license to grow produce in Texas, it did require the Texas Department of Health to adopt rules for safe handling of fruits and vegetables.
State health officials are also required under the new law to provide "best practices" education programs to the food businesses they regulate. It also addresses regulation of farmers' markets in larger Texas counties that have local health departments, and prevents officials from mandating "temperature control requirements."
All of that churned up a lengthy rule-writing assignment for an agency that currently regulates 11,000 licensed food producers. Agency officials anticipate that only a few existing licensed food establishments will switch over to becoming unlicensed cottage-food operations.
The new law includes definitions for "baked goods" and "cottage-food production operation." It prohibits local health departments from regulating them, but requires both state and local health departments to keep records of any complaints they get about cottage foods.
Rule-makers produced 12 pages of requirements for the new law in a document roughly four times longer than the bill itself. The new rules state, in part:
"A cottage food production operation allows an individual to operate out of the individual's home, who produces a baked good, a canned jam or jelly, or a dried herb or herb mix for sale at the person's home; has an annual gross income of $50,000 or less from the sale of the described foods; and sells the foods produced only directly to consumers."
Labels must state the food was "made in home kitchen, food is not inspected by the Department of State Health Services or a local health department" in at least the equivalent of 11-point font and in a color that provides a clear contrast to the background.
The rules also require that "ingredients shall include components of the ingredients" and also dictate the ink and typeface requirements. Internet sales are prohibited and no health claims can be made in advertising.
Home kitchens would be required to list on labels all ingredients in descending order, including all food coloring and preservatives and follow the U.S. Food and Drug Administration (FDA) guidelines for allergen labeling.
A 30-day comment period on the new rules ends February 26.
Though the political fight over GE salmon has primarily focused on the potential environmental impact of the technology--a fight fueled by environmental groups and lawmakers with constituent salmon interests--the petition, brought by Consumers Union, Food & Water Watch and the Center for Food Safety is focused primarily on food safety concerns.
Developed by Massachusetts-based AquaBounty Technologies, the engineered AquAdvantage Salmon are essentially Atlantic salmon with an inserted growth gene from a Chinook salmon and an antifreeze gene from an ocean pout. They grow twice as fast as typical Atlantic salmon and require approximately 10 percent less feed to achieve the same weight.
If cleared by FDA, the fish would be the first GE animal approved for human consumption.
"Atlantic salmon is a substance traditionally regarded as safe. [AquaBounty's] GE process significantly alters the salmon's composition, however, in a way that is reasonably expected to alter its nutritive value or concentration of constituents, and the new substance raises safety concerns," reads the petition. "Under the Agency's regulations and guidelines, such a substance must be treated as a food additive and the Agency must make a closer inquiry into the safety of its consumption, including, but not limited to, subjecting it to extensive pre-market testing."
The petition also asks that the agency not designate the GE salmon as generally recognized as safe (GRAS). As the petition notes, food additives are presumed to be unsafe, and therefore the company seeking approval for an additive "carries the burden to prove that a food additive is GRAS.
The groups blasted the data supplied by the company to FDA's Center for Veterinary Medicine and said it "cannot be relied upon to show that AquAdvantage salmon is safe to consume."
"The data FDA has on GE salmon, which were supplied by Aquabounty, are incomplete, biased, and cannot be relied upon to show that the GE salmon is safe to consume," said Food & Water Watch executive director Wenonah Hauter. "Aquabounty's own study showed that GE salmon may contain increased levels of IGF-1, a hormone that helps accelerate the growth of the transgenic fish and is linked to breast, colon, prostate, and lung cancer."
In the petition, consumer groups warn that the potential health risks of GE salmon are no "different from a number of food additives the FDA has banned in the past, including those that are cancer causing."
"FDA's choice to allow the first proposed transgenic animal for food to somehow only be review as a drug is contrary to law, science and common sense," said George Kimbrell, senior attorney for the Center for Food Safety. "Public health and transparency should be championed, not skirted, particularly when contemplating such an unprecedented approval."
Aquabounty did not respond to requests for comment on the petition.
The company maintains that the GE salmon are biologically and nutritionally identical to non-GE salmon and pose no threat to human health.
LOUISVILLE, Ky.
The one-time vice president of a health care company has pleaded guilty to charges of misbranding and altering drugs and to committing health care fraud.
A statement from the U.S. Attorney's Office says 62-year-old Johnny Perry of Mount Washington entered the plea Monday in U.S. District Court in Louisville. Perry served as an executive with National Respiratory Services.
A grand jury charged Perry in August with altering medications that were not FDA approved, but billing them as approved. Perry was also charged with submitting false claims to Medicare for the cost of FDA approved drugs. Prosecutors say Medicare paid the company $2,030,343 from November 2006 through June 2008.
Perry also faced charges of misbranding and altering inhalation drugs.
A sentencing date has not been set.
As a result of increasing concerns associated with the
use of Actos® medication, manufacturer Takeda Pharmaceuticals has been forced to cut its work force. The company announced on January 18, 2011 that 2,800 jobs within the United States and in Europe will be cut as the result of decreasing sales. The company has also purchased Swiss drug company, Nycomed.
The company expects that sales will continue to drop as concerns with Actos increase and the introduction of generic versions of Actos enter the market. They have made plans to cut jobs slowly over the course of four years.
This reduction in Takeda’s workforce will represent about 9% of the company but is expected to help the company save $1.7 billion by March of 2016.
The FDA approved Actos for the treatment of type II diabetes in July of 1999. This once a day pill was designed to aid the body’s sensitivity to insulin and accrued sales of $4.3 billion for Takeda Pharmaceuticals in 2010. However, these sales quickly dropped after concerns associated with Actos were actively reported to the FDA.
Generic versions of Actos medication are expected to be released by August of 2013, further reducing sales dollars for Takeda.
Victims who have taken Actos claim that Actos causes bladder cancer and allege that Takeda failed to properly issue sufficient warnings to patients and the medical community.
In September of 2010, the FDA began to review safety concerns of Actos due to interim data from an ongoing ten year study that revealed a link between
Actos and bladder cancer. The agency mandated updated warning labels for Actos in the U.S. and the health regulating agency in Europe also mandated new warning labels as well.
Actos lawyers continue to pursue compensation for individuals who have suffered bladder cancer injuries after taking Actos.
Associated Press (AP) that when people use it for the first time, it sort of surprises them and often makes them laugh. He said about 24 cases have been sold since stocking shelves late last month. But at least one storeowner said he sent a case back to the distributor because it wasn’t selling. “It’s garbage,” the Parsley & Sage storekeeper, who wished to remain anonymous, told Bill Hutchinson of the
New York Daily News. Democratic US Senator Charles Schumer of New York said he wants the US Food and Drug Administration (FDA) to review AeroShot, fearing it will be abused, and users will party until they drop dead. Edwards said despite the fears that young adults will abuse it, it is no different than the many caffeine-packed drinks that are on the market, often dubbed as “blackout in a can” because of their potency. He explained that AeroShot is not targeting anyone under 18 and it safely delivers caffeine into the mouth, just like coffee does. “Even with coffee — if you look at the reaction in Europe to coffee when it first appeared — there was quite a bit of hysteria,” Edwards told the AP. “So anything new, there's always some knee-jerk reaction that makes us believe 'Well, maybe it's not safe.” Dr. Lisa Ganjhu, a gastroenterologist at St. Luke’s Roosevelt Hospital in New York, said people need to be aware of how much caffeine they are ingesting. “You want those 10 cups of coffee, it will probably take you a couple hours to get through all that coffee with all that volume that you are drinking,” Ganjhu told the AP and New York Daily News. “With these inhale caffeine canisters you can get that in 10 of those little canisters -- so you just puff away and you could be getting all of that within the hour.” Edwards said the product packaging warns people not to consume more than three AeroShots per day. The makers of AeroShot state they are not trying to replace coffee, but are offering an alternative for people to get their caffeine fix on the go. “AeroShot can be used in a variety of settings inconvenient for liquids, such as when you study in the library, board an airplane or get into the car for a long drive,” the company says on its website. “It’s easy to take AeroShot with you when you go biking, skiing, curling, or any other activity that consumes energy.” AeroShot is manufactured in France and is the primary product of Cambridge-based Breathable Foods Inc. Edwards had the pleasure of discussing the potential for breathable foods with celebrity chef Thierry Marks in 2007. “We were discussing what interesting culinary art experiments we might do together and I had the idea that we might breathe foods since I’ve done a lot of work over the last 10 or 15 years on medical aerosols,” Edwards said. Edwards’ first venture was to create breathable chocolate, called Le Whif. Now he is preparing to promote a product called Le Whaf, which involves food and drinks being placed in futuristic-looking glass bowls that offer low-calorie clouds of flavor. You can see more AeroShots by visiting the website at:
http://www.aeroshots.com/
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