How to Find the Right “DIETARY SUPPLEMENTS” for Your Specific Product (Service)

These have to match what is specified in the master manufacturing record.

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Compliance4All, a leading provider of professional training for all areas of regulatory compliance, is organizing a 90-minute webinar on the topic, “Dietary Supplements CGMPS – 21 CFR 111 Compliance”, on February 5. John E. Lincoln, a medical device and Regulatory Affairs consultant, will be the expert at this webinar.

Please visit http://bit.ly/2DIk8lf to enroll for this webinar.

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How to find the right dietary supplements for your specific product (service) can be quite a challenge, if you are one of the players in the industry. The reason is this: manufacturers, labelers and packagers of dietary supplements, and even those who hold them, have to comply with the requirements set out in 21 CFR Part 111.

21 CFR Part 111, or what is called the “DS CGMP rule”, requires those who manufacture, package, label and stock dietary supplements to ensure the quality of the product by adhering strictly to the packaging and labeling requirements set out in this Part. These have to match what is specified in the master manufacturing record.

Till the FDA published the Dietary Supplements CGMPs as a “Final Rule”, which brought 21 CFR 111 into existence, the Quality Management Systems and controls on dietary supplements were loose and voluntary in nature. About the only requirement was the one set out by the Dietary Supplement Health and Education Act of 1994 (DSHEA), by which the Congress defined what is meant by a “dietary supplement”, and only required that every supplement be labeled a dietary supplement.

Complying with 21 CFR 111 is not optional

All that has changed with 21 CFR 111. To start with, the FDA now has a set of regulations for dietary supplements that is different from what is set out for conventional foods and drug products.  And then, players in the dietary supplements field that fail to comply with these requirements can have their products termed “adulterated” or “misbranded” by the FDA.

Despite the introduction of this Part, considerable confusion abounds in the industry as to just what type of manufacturing controls and record keeping, and labeling content the FDA requires, with the result that this Part continues to be a regulatory sore point for many new and established companies in the industry.

It is this confusion that this webinar seeks to clarify. John E. Lincoln will help participants of this session resolve these issues.

John will explain all the aspects of FDA Part 111, which will include Quality Management System/Quality Assurance/Quality Controls, personnel, facilities, equipment, software controls, production and Process Controls, holding and distribution, complaints and returns, and records.

At this 90-minute webinar, which is aimed at benefiting Senior Management in the dietary supplements industry, QA/RA, R&D, Consultants, those in Engineering and Marketing, those tasked with Product, Process, Validations and CGMP responsibilities, as well as other interested consumer groups, medical and other healthcare professionals, staff and office personnel, and start-ups, John will cover the following areas:

  • History of Dietary Supplement regulation in the U.S
  • The Dietary Supplement Health and Education Act (DSHEA)
  • The key requirements of the Dietary Supplements CGMPs, 21 CFR 111
  • Required steps for CGMP compliance
  • Problem areas, common pitfalls
  • Implementation: Systems, templates and tools.

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About the speaker:

John E. Lincoln is a graduate of UCLA. His experience also includes managing pilot production, regulatory affairs, product development/design control, 510(K) submissions, risk management per ISO 14971, and projects. He brings over 28 years of experience in the FDA-regulated medical products industry, during which he has worked with companies ranging from startups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt.

6 artificial flavorings with cancer-causing properties – (FDA bans)

The announcement from the U.S. Food And Drug Administration carries a yawn-inducing title: “FDA Removes 7 Synthetic Flavoring Substances from Food Additives List.” It sounds like a regulatory move aimed at food-makers, and it is. But it’s one that has a slightly alarming backstory: The FDA is effectively banning these artificial substances because they have been shown to cause cancer in animals.

Under a provision of the Federal Food, Drug, and Cosmetic Act known as the Delaney Clause, the FDA cannot approve ingredients for use in food that have been found “to induce cancer in humans or animals at any dose.” Six of the substances “delisted” (effectively, banned) by the FDA have been found to cause cancer in animals exposed to very high doses. The seventh ingredient was delisted because it is no longer used at all by the food industry, the FDA says.

The six other artificial flavorings — benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, and pyridine — are now no longer permitted for use in food, even though the FDA states that previous testing found “they do not pose a risk to public health under the conditions of their intended use.” Eager to not incite any kind of a panic, the FDA is stating the animals that developed cancer did so after exposure to very high levels of these flavorings — much higher doses than any human would likely ingest: “The FDA is only revoking the listing of these six synthetic flavorings as a matter of law. The FDA has concluded that these substances are otherwise safe.”

This latest FDA mandate comes on the heels of two other moves away from non-natural ingredients: In January, Dunkin’ announced it would phase out artificially derived coloring in its products by the end of the year, and last month, McDonald’s pledged that it would remove all artificial colorings and preservatives from its classic burgers (minus those pesky pickles). Taken together, these individual developments suggest the movement away from artificial colorings, preservatives, and flavorings is gaining serious traction.

FDA Viral news related to Health every one has to know https://goo.gl/tVE3WP

You Can Check the Restaurant’s FDA Rating on Hygiene!

The aim is to reduce the incidence of food-borne illnesses and associated costs to the economy.

In the first phase, the FDA carried out the rating for 30 restaurants. These included 15 in Mumbai, 10 in Pune and five in Nagpur, which got their star ratings at a public function by officials on Thursday.

Pallavi Darade, Commissioner, FDA, spoke to The Times of India, highlighting the purpose of the unique rating system.

She said, “The food hygiene rating given will reflect our inspection findings. The purpose of this scheme is to allow consumers to make informed choices about the places where they eat out. The aim is to reduce the incidence of food-borne illnesses and associated costs to the economy.”

So how does this system help you and me? Let’s find out!

  • The restaurants will have to complete an online self-assessment for hygiene, which would be later followed by FDA inspectors inspecting the restaurants.
  • The parameters that these restaurants will be rated on include cleanliness, design and facilities, availability of water and soap, non-toxic fittings, walls free of flakes, window nets, sufficient light and air, food thawed hygienically, proper reheating, use of good oil etc.
  • The FDA will also use a scoring system to rate how well a food business is run. While the best restaurant will get five stars, the worst will get none.
  • Another unique way these assessments will benefit restaurants is the opportunity to earn a tag that identifies them as a “responsible place to eat”. The only way to be rated on this parameter is if the staff maintains hygiene and undergoes periodic health checks, every six months.
  • The staff will also have to ensure that the surplus food at the restaurant is not wasted but donated and that their beverages are made in potable water, and cooking methods are hygienic.
  • These eateries and joints will also be rated on the advice they give out to customers, whether it is about maintaining a balanced diet or minimising their sugar and salt intake. They can create awareness through posters, display screen, menu etc.
  • Restaurants will also receive brownie points if their kitchens are open to consumers who want to check if the food handlers and cooks wear protective gear.
  • Eateries that have an effective consumer redressal mechanism in place including WhatsApp numbers and emails will be considered too.
  • These are some of the 20 parameters that will be used to examine restaurants.

 

Most deadly opioid not among drugs to be added to random drug testing for airline pilots

Aircraft filled with passengers cross the country, and the pilots become responsible for many lives.

DETROIT – Airline pilots are randomly tested for safety reasons, but the Local 4 Defenders uncovered serious lapses in the testing program that could cause concern for flyers.

Right now, pilots aren’t being tested for some of the most addictive painkillers on the market, and while the federal government said it’s working feverishly to fix that, pilots will not be tested for one of the biggest opioid killers, fentanyl, even though top safety officials said they should be.

Planes take off from Detroit Metro Airport and other airports across the country about 75,000 times each day. Aircraft filled with passengers cross the country, and the pilots become responsible for many lives.

But pilots aren’t being tested for many popular opioids, and 64,000 people die every year from opioid overdoses.

“The first reaction anyone has is, ‘How could this possibly be bad?'” Dr. Michael Harbut, M.D. said.

Doctors familiar with opioid abuse know the dangers of addiction. Those hooked on opioids have a terrible time getting clean, and addiction can happen to anyone, including airline pilots.

Pilot Brian Halye, and his wife, Courtney Halye, recently died in an apparent overdose.

Brian Halye, of Ohio, had been a pilot for nine years. He and his wife died from fentanyl. They were two of 20,000 fentanyl overdoses in 2016.

Fentenyl claims more lives than any other type of opioid, and there is no plan in place to test for it in pilots anytime soon. That worries passengers, who had no idea pilots were not being tested.

“With the epidemic that it is in society today, why wouldn’t we?” asked Ryan Rezmierski, of Ann Arbor.

Pilots are currently tested for alcohol and drugs such as marijuana, cocaine, heroin, meth and PCP. But some of the most popular prescription drugs aren’t on the list.

Government bureaucracy and battles with the unions increase the amount of time it takes to add new drugs to the testing list. It’s been many years since the testing policy has been adjusted.

Federal officials said they will soon add four opioid prescription medications — hydrocodone, hydromorphone, oxycodone and oxymorphone — that would catch most of the popular painkillers.

“If you’re going to go looking for them, once you find them, you really need to know to be responsible to society and to the flying public on what to do next,” Harbut said.

While it’s obvious flyers don’t want pilots high on pills, doctors and union officials warned that testing for prescriptions is an imperfect science. Medications taken under a doctor’s care are perfectly safe and should be allowed, so finding abuse isn’t as easy as finding a drug in a blood or urine test.

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Many UK SMBs don’t invest in security solutions

The cybersecurity company partnered with YouGov to survey 1,0009 senior decision makers across the UK to determine.

A third of UK small businesses are risking their online safety by operating at or below the “security poverty line,” according to new research from Duo Security.

The cybersecurity company partnered with YouGov to survey 1,0009 senior decision makers across the UK to determine how much they are spending on cybersecurity and whether government initiatives such as Cyber Essentials and Cyber Risk Aware have been effective at protecting SMBs from cyber threats.

The survey found that 38 percent of small businesses had spent nothing at all to protect themselves from cybersecurity threats this year and 30 percent of respondents said that less than three percent of their overall budget was allocated for cybersecurity.

Duo Security’s survey also revealed that 36 percent of UK small businesses are operating at or below the security poverty line and are close to being unable to effectively protect their organization from cybersecurity threats. Despite this though, 45 percent of those surveyed do not consider themselves to be possible targets for hackers.

For depth Article http://snip.ly/pcmfy

U.S. asks China not to enforce cyber security law

The United States has been communicating these concerns directly to high level officials and relevant authorities in China

GENEVA (Reuters) – The United States has asked China not to implement its new cyber security law over concerns it could damage global trade in services, a U.S. document published by the World Trade Organization showed on Tuesday.

China ushered in a tough new cyber security law in June, following years of fierce debate around the move that many foreign business groups fear will hit their ability to operate in the country.

The law requires local and overseas firms to submit to security checks and store user data within the country.

The United States, in a document submitted for debate at the WTO Services Council, said if China’s new rules enter into full force in their current form, as expected by the end of 2018, they could impact cross-border services supplied through a commercial presence abroad.

“China’s measures would disrupt, deter, and in many cases, prohibit cross-border transfers of information that are routine in the ordinary course of business,” it said.

“The United States has been communicating these concerns directly to high level officials and relevant authorities in China,” the U.S. document said, adding it wanted to raise awareness among WTO members about the potential impact on trade.

“We request that China refrain from issuing or implementing final measures until such concerns are addressed.”

China’s Ambassador to the WTO Zhang Xiangchen spoke on Tuesday at a WTO conference panel on trade protectionism, which he said was an underestimated problem that was causing a crisis at the WTO.

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