Monday December 11, 2017

Anti-epilepsy pill manufactured with 3D printer gets US FDA approval

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www.fdalawyersblog.com

Washington: The US Food and Drug Administration has approved the sale of an anti-epilepsy pill manufactured with a three-dimensional (3D) printer.

Photo Credit: www.medscape.com
Photo Credit: www.medscape.com

Aprecia Pharmaceuticals announced that the FDA had approved its Spritam medication for the treatment of epilepsy.

The company said that with its ZipDose 3D printing technology, it is possible to create a detailed, porous structure which allows the pill to dissolve faster while delivering up to 1,000 mg of medication in a single dose.

Aprecia’s Spritam, the first manufactured with 3D printing technology to win FDA approval, will reach the market early in 2016.

Three-dimensional printing technology has lowered costs substantially over the past few years, enabling designers and experts in a range of fields to create complex pieces and tools in record time.

The FDA has approved the commercial distribution of several medical and prosthetic devices created by 3D printers.

Aprecia said the ZipDose technology will improve the administration of medications to children and the elderly.

(IANS/EFE)

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 Dairy farmers want US regulators to Banish the term “soy milk” : But Why?

The sour history over who gets to use “milk” reaches back to at least 1997, when a soy foods group petitioned the FDA to recognize the term “soymilk"

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A photo shows the ingredients label for soy milk at a grocery store in New York, Feb. 16, 2017. The dairy industry says terms like “soy milk” violate the federal standard for milk, but even government agencies have internally clashed over the proper term.VOA
  • The U.S. Department of Agriculture “fervently” wanted to use the term “soy milk” in educational materials for the public
  • That irked the Food and Drug Administration, the agency that oversees the rule defining milk as coming from healthy cows
  • The sour history over who gets to use “milk” reaches back to at least 1997, when a soy foods group petitioned the FDA to recognize the term “soymilk”

New York, July 4, 2017: Dairy farmers want U.S. regulators to banish the term “soy milk,” but documents show even government agencies haven’t always agreed on what to call such drinks.

The U.S. Department of Agriculture “fervently” wanted to use the term “soy milk” in educational materials for the public, according to emails recently released in response to a lawsuit. That irked the Food and Drug Administration, the agency that oversees the rule defining milk as coming from healthy cows.

It’s “not a trivial decision,” the FDA warned in one of the 2011 emails about the USDA’s desire to use the term.

The sour history over who gets to use “milk” reaches back to at least 1997, when a soy foods group petitioned the FDA to recognize the term “soymilk”. A couple of years later, the group pointed out that the FDA itself had used the term. Even now, the National Milk Producers Federation says it’s working to build support for legislation directing the FDA to enforce the federal standard. The dairy group says both “soy milk” and “soymilk” are inappropriate ways to describe non-dairy drinks made from soybeans, and that the one-word version is just an attempt to get around the definition.

ALSO READNDDB accounts for 90 percent of milk production in India: T Nanda Kumar

There are plenty of other food names at issue. A European Union court recently ruled that a company named TofuTown can’t describe its products as “cheese.” U.S. rice producers have railed against “pretenders ” like diced cauliflower and said they may take the issue to the FDA.

But the FDA hasn’t even always been able to get other agencies to go along, as illustrated in the emails obtained by the Good Food Institute, which advocates alternatives to industrial animal agriculture. The GFI sued the FDA for public records relating to soy milk.

The email exchange started when a nutrition adviser at the Department of Health and Human Services alerted the FDA that the USDA planned to use “soy milk” in educational materials about dietary guidelines.

“USDA staff are preparing consumer publications and fervently want to use the term ‘soy milk’ because beverages are widely marketed this way,” the adviser wrote.

The FDA bristled and provided the federal definition of milk as a “lacteal secretion” from cows. Therefore, the FDA declared that referring to soy, almond and rice drinks as “milk” would be incorrect. It suggested the other agency say “beverage” or “fortified beverage.”

When that didn’t put the matter to rest, the FDA warned that the USDA’s use of the term could undermine the FDA’s regulatory authority.

That apparently didn’t stop the USDA, either.

“They are adamant about using the term in consumer publications,” the nutrition adviser wrote. The USDA had indicated that it would use “soy beverage” in official policy documents, but it wanted to use “plain language” in materials for the public.

Despite the federal regulation, others may also consider “soy milk” an acceptable term. The Merriam-Webster dictionary doesn’t limit milk’s definition to cows, saying it is “a fluid secreted by the mammary glands of females for the nourishment of their young.”

It also allows for a “food product produced from seeds or fruit that resembles and is used similarly to cow’s milk.”

Asked how the spat was resolved, the USDA provided materials from 2011 that use both terms by referring to “soymilk (soy beverage).” The agency also uses the term elsewhere, including on its “Choose My Plate” website, which currently says “calcium-fortified soymilk (soy beverage)” is part of the dairy group.

The National Milk Producers Federation says the USDA’s usage of the term shows even other government agencies are confused about how to describe soy beverages in the absence of consistent enforcement by the FDA.

The FDA declined to comment. (VOA)

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Zika Virus Fight: FDA Plans To Exterminate Disease With Genetically Modified Mosquitoes

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Zika virus

There is a new plan to combat the growing threat of Zika virus with genetically modified mosquitoes; the F.D.A. has given preliminary approval to conduct a trial just north of Key West on Saturday. Experts claimed that these insects are unlikely to harm humans, animals or the environment. “The consequences of escape, survival, and establishment of…

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Spicy lies: Yippee ad claims being safe, FDA disagrees

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img1440393117822By NewsGram Staff Writer

After the recent Maggi ban and its subsequent upliftment, now Yippee noodles is on the path of courting controversy.

Today’s  Hindustan Times flashed a huge brightly colored advertisement that claims that Yipee is safe and bases the claim on a number of tests it underwent to prove its credibility. However, Indian Express, dated 24th August 2015, in a report claims that excessive lead has been found in the samples of Yippee noodles.

The report says that Uttar Pradesh Food and Drug Authority (FDA) recently found excess lead in ITC’s Yippee noodles. The samples tested contained lead amount  “in excess to the permissible limit”. The tested samples had 1.057 ppm of lead as against the permissible amount of below 1 ppm.

The report has been sent to the FDA Chief Commissioner for permission before filing an official case.