09.02.2012 12:59:07
Last year the Texas Legislature approved a bill to allow the sale of food made in uninspected and unlicensed home kitchens, but some now say the state's rules implementing the new law are unnecessarily burdensome and subvert the measure's intent.
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.
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.
08.02.2012 12:59:02
Consumer groups formally petitioned the U.S. Food and Drug Administration Tuesday to switch gears and evaluate genetically engineered (GE) salmon as a food additive, not a veterinary drug, as the agency has been for several years.
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.
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.
08.02.2012 12:59:03
Research by the Centers for Disease Control and Prevention indicates blood levels of trans fatty acids in U.S. white adults dropped by 58 percent from 2000 to 2009 -- a decrease being hailed as huge public health progress.
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.
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.
2012-02-09 09:20:51
For those who want their daily dose of caffeine without having to drink a cup of coffee or eat a chocolate bar, now you can buy a lipstick-sized tube and inhale it, which has some officials worried that the product could become the next abused club drug by young adults. The product, called AeroShot, was developed by biomedical engineering professor David Edwards of Harvard University. AeroShot comes in a single gray and yellow canister, sold online and at most convenient stores for $2.99. It contains 100 milligrams of caffeine powder plus B-vitamins, and each container has up to six uses. Once a user puffs the AeroShot into his or her mouth, the powder, which is flavored, begins to dissolve almost immediately. The product hit store shelves late last month in Massachusetts and New York, and is also available in France. Edwards said AeroShot is safe and has no common additives, like taurine, which is commonly used to enhance the caffeine effect in many energy drinks. He also said the product is calorie-free. He told the
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/
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/
09.02.2012 8:00:00
The amount of trans fat in the American bloodstream fell by more than half after the Food and Drug Administration required food manufacturers to label how much of the unhealthful ingredient is in their products, according to a new study. Blood levels of trans fat declined 58 percent from 2000 to 2008. FDA began requiring trans-fat labeling in 2003.
08.02.2012 11:00:00
WEDNESDAY, Feb. 8 (HealthDay News) -- Sklice Lotion, a prescription-strength shampoo to treat head lice, has been approved by the U.S. Food and Drug Administration for people six months and older, the French product maker Sanofi said. The shampoo ...
07.02.2012 17:31:58
The Association for the Advancement of Medical Instrumentation (AAMI) will join forces with the U.S. Food and Drug Administration to host a fall summit on how to improve interoperability in healthcare--without compromising patient safety.
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