Showing posts with label fda. Show all posts
Showing posts with label fda. Show all posts

29 April 2017

HEALTH - FDA Targets Illegal Cancer Treatment Claims

It is a violation of the Federal Food, Drug and Cosmetic Act to market and sell products that claim to prevent, diagnose, treat, mitigate or cure diseases without first demonstrating to the FDA that they are safe and effective for their labeled uses.

This week the FDA sent warning letters to 14 US-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer.

The products are being marketed for human and/or pet use and mainly sold through websites and social media.

“Consumers should not use these or similar unproven products because they may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment,” said Douglas W. Stearn, director of the Office of Enforcement and Import Operations in the FDA’s Office of Regulatory Affairs.

The illegally sold products cited in the warning letters include a variety of product types, such as pills, topical creams, ointments, oils, drops, syrups, teas and diagnostics (such as thermography devices).

The products make illegal, unproven claims regarding preventing, reversing or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims.

Companies receiving the warning letters are:
  • AIE Pharmaceuticals Ltd.
  • Amazing Sour Sop Inc.
  • BioStar Technology International, LLC
  • Caudill Seed & Warehouse Inc.
  • DoctorVicks.com
  • Everything Herbs
  • Hawk Doc Natural Salve, LLC
  • Healing Within Products & Services Inc.
  • LifeVantage Corporation
  • Nature’s Treasure Inc.
  • Oxygen Health Services, LLC
  • Sunstone Inc.
  • The Vibrant Health Store, LLC dba Dr. Christopher’s Herbs
  • The Vitamin C Foundation

It is important to consult with a veterinarian or physician before using any products for health care treatment.

The FDA encourages health care professionals and consumers to report adverse reactions associated with these or similar products to the agency’s MedWatch program.



10 April 2017

HEALTH - Cattle Veterinarians Asked to Provide Illegal VFD's

With the implementation of the Veterinary Feed Directive (VFD) at the beginning of the year, it’s not surprising there have been a few challenges as farmers, feed mills and veterinarians adapt to the new regulations.

The AVMA and American Associ­ation of Bovine Practitioners (AABP) published a joint statement March 6 on the AVMA@Work blog warning that both organizations had received reports veterinarians had been pressured to issue veterinary feed directives for chlortetracycline-containing feeds in unapproved formulations or for unapproved indications.

The VFD was implemented to eliminate the use of antibiotics in feed for production purposes, ie: growth promotion and feed efficiency, and have them used judiciously and only when appropriate for specific animal health purposes.

The goal is to reduce the risk of antibiotic resistant bacteria.

Canadian officials and the U.S. Centers for Disease Control caution the “growing use of antibiotics in farm animals' food supply is worsening the problem of antimicrobial resistance – the phenomenon of bacteria becoming immune to antibiotics,” a Huffington Post article stated.

Both the AVMA and AABP are encouraging their members to educate themselves about the VFD and work with clients, producers and feed mills to ensure that everyone is following the Veterinary Feed Directive rules.

A common question in issuing VFDs for medicated mineral feed is determining whether the feed is a “free choice” or a “hand fed” feed.

“Hand fed” is designated when there is a concern for adverse drug reactions; the animals are fed daily in order for them to be observed daily.  

Feed – including mineral feed – can only be labeled as free choice when both the drug label and the feed formulation have been approved for this indication by the FDA.

Before the VFD was implemented, some feed mills and customers were using their own mineral formulation mix, adding chlortetracycline, and then feeding it as a free choice mineral feed.

Since the formulation was not approved by the FDA, the intake level and dose would be unknown; therefore this would be an illegal use.

The joint statement goes on to say:
“To date, no regulatory enforcement has occurred as a result of this activity; however, veterinarians who are asked to write VFDs for these mineral mixes that are clearly being used as free choice feeds are placed in a difficult position because this is not allowed under the VFD rules. Writing such VFDs is illegal, and veterinarians should not provide them.”

The organizations encourage veterinarians to talk with their producers and feed mills about the legal and illegal uses of medicated feeds so that everyone is familiar and stays in compliance with the VFD regulations.

22 March 2017

HEALTH - More Pet Food Recalls

Concerns about pet food may be on the rise this year as more products have been recalled since InfoStream’s initial report in February.

Evanger’s Dog & Cat Food voluntarily expanded its recall of Hunk of Beef and is also recalling Evanger’s Braised Beef and Against the Grain’s Pulled Beef Products due to potential adulteration with pentobarbital.  

The 12 oz. cans of dog foods that are being voluntarily recalled have the following barcodes.  The numbers listed below are the second half of the barcode, which can be found on the back of the product label:
  • Evanger’s: Hunk of Beef: 20109
  • Evanger’s: Braised Beef: 20107
  • Against the Grain: Pulled Beef: 80001

Consumers may return any can of these Evanger’s products to their place of purchase for a full refund for the inconvenience.

Customers may contact the company at 1-847-537-0102 between 10am and 5pm Central Time, Monday - Friday with any questions.

WellPet has initiated a voluntary recall of a limited amount of one canned topper product due to potential elevated levels of naturally occurring beef thyroid hormone.

Recalled Product Details:
  • Wellness 95% Beef Topper for Dogs – 13.2 oz
  • Best-By Dates of 02 FEB 19, 29 AUG 19 and 30 AUG 19 (located on the bottom of the can)

These WellPet products have the potential to contain elevated levels of naturally occurring beef thyroid hormone.

Elevated levels may affect a dog’s metabolism and can be associated with anxiousness, increased thirst, increased urinary output and weight loss.

However, with prolonged consumption these symptoms may increase in severity and may include vomiting, diarrhea, and rapid or difficulty breathing.

While multiple studies indicate that, for the vast majority of pets, symptoms are reversible once the pet stops eating product with elevated thyroid hormone, if your pet has consumed this product and has exhibited any of these symptoms, please contact your veterinarian.

Camelle Kent, chief executive officer of WellPet, the maker of Wellness products, said, “We fully intend on maintaining the trust you have placed in us to keep your pets healthy and happy, and are removing this product as part of our ongoing commitment to quality and food safety.”

If you have any of the 13.2 oz recipe with these three best-by dates, please email WellPet at wecare@wellpet.com or call 1-877-227-9587.

Blue Buffalo is voluntarily recalling one production lot of BLUE Wilderness® Rocky Mountain RecipeTM Red Meat Dinner Wet Food for Adult Dogs.

Like Wellness, this product has the potential to contain elevated levels of the beef thyroid hormones.

Wet Food for Adult Dogs 12.5 oz cans with a UPC code of 840243101153 and best before date of June 7, 2019 are impacted.

Consumers who have purchased this product should dispose of it or return it to the place of purchase for a full refund.

Consumers with questions may contact Blue Buffalo at 866-201-9072 from 8am to 5pm Eastern Time Monday through Friday, or by email at  CustomerCare@bluebuffalo.com for more information.

EuroCan Manufacturing is voluntarily recalling Lot Number 84 consisting of its individually shrink-wrapped, 6-pack, 12-pack and 25-pack bags of Barnsdale Farms®, HoundsTooth® and Mac's Choice® Pig Ears because they have the potential to be contaminated with Salmonella.

Salmonella can affect animals eating the products and there is a risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

The pig ears were distributed throughout the United States and Canada.

Consumers who have purchased any of the above-described Barnsdale Farms® pig ears should return product to the place of purchase for a refund.

Contact the company Monday – Friday from 9am to 5 pm Eastern Standard Time at (888) 290-7606 with any questions.


Stay on top of pet food recalls by visiting the AVMA or FDA websites.

19 March 2017

HEALTH - Canine Cancer Drug Taken Off the Market

Oasmia Pharmaceutical AB has taken a canine cancer drug, Paccal Vet, or paclitaxel for injection, off the market to study lowering the dose to reduce adverse effects.

Paccal Vet had been conditionally approved by the FDA for the treatment of:
  • Non-resectable stage III, IV or V mammary carcinoma in dogs that have not received previous chemotherapy, or radiotherapy.
  • Resectable and non-resectable squamous cell carcinoma in dogs that have not received previous chemotherapy, or radiotherapy.

To receive a conditional approval from the FDA, a drug company must prove, among other things, that the animal drug is safe and has a “reasonable expectation of effectiveness” when used according to the label for the proposed conditionally-approved use.

Conditional approval allows the drug company to legally market the animal drug for up to five years.

During this period, the company develops and submits to the FDA the necessary data to prove that the drug meets the “substantial evidence” standard of effectiveness for full approval.

Paccal Vet-CA1 had been available to a limited number of oncology specialists and veterinarians are now being told to stop using the drug.

Oasmia anticipates that lowering the dose to reduce side effects and improve comfort for companion animals will make the product far more attractive to veterinarians and pet owners.

Paclitaxel has been used in the treatment of people with breast, lung, prostate and other cancers.


16 February 2017

HEALTH - Plethora of Pet Food Recalls

If it seems like there have been an awful lot of pet food recalls this year, it’s because there have been 21 products recalled in the first month and a half of 2017.
 
Compared to 39 pet food products recalled March through December last year (10 months), according to the AVMA’s animal food recalls and alerts webpage.

The most recent is Blue Buffalo Homestyle Recipe Healthy Weight, Chicken Dinner with Garden Vegetables dog food which was voluntarily pulled by the company due to possible metal contamination.

The affected cans are 12.5oz with a UPC code of 8-40243-10017-0, and expiry date of August 3, 2019.

PetSmart’s Grreeat Choice Adult Dog Food with Chicken & Rice, 13.2 oz cans were recalled last week due to metal contamination that could be a choking hazard.

This month there has also been two types of dog food recalled due to the potential presence of pentobarbital, a drug that is most commonly used for pet euthanasia.

The affected dog foods are:
  • Against the Grain Pulled Beef w/ Gravy Dinner, 12 oz can, Lot #2415E01ATB12; second half of the UPC code is 80001; and expiration date of December 2019.

  • Evanger’s Hunk of Beef Canned Food, Lot numbers that start with 1816E03HB, 1816E04HB, 1816E06HB, 1816E07HB, and 1816E13HB, and have an expiration date of June 2020. The second half of the barcode on these products reads 20109, which can be found on the back of the product label.

Other pet foods recalled in 2017:
  • Rogue All Purpose Rabbit Pellets

  • Blue Ridge Beef Turkey with bone, 2lb package

  • 9Lives Meaty Pate Chicken & Tuna, 13oz, 12/case

  • 9Lives Meaty Pate Seafood Platter, 5.5oz and 13oz

  • 9Lives Meaty Pate Super Supper, 5.5oz and 13oz

  • 9Lives Meaty Pate with Chicken and Seafood, 4-pack of 5.5oz pkgs

  • 9Lives Meaty Pate with Chicken and Tuna, 5.5oz

  • 9Lives Meaty Pate with Chicken Dinner, 5.5oz

  • 9Lives Meaty Pate with Liver and Chicken, 4-pack of 5.5oz pkgs

  • 9Lives Meaty Pate with Ocean Whitefish, 5.5oz pkg

  • 9Lives Seafood Poultry Variety Pack, 5.5oz

  • 9Lives Meaty Pate with Chicken & Tuna, 4-pack of 5.5oz pkgs

  • EverPet Mixed Grill Dinner, 13oz pkg

  • Special Kitty Beef and Liver Dinner, 13oz pkg

  • Special Kitty Classic Tuna Dinner, 13oz pkg

  • Special Kitty Mixed Grill Dinner (w/ & w/o printed wrap), 13oz

  • Special Kitty Super Supper, 13oz pkg


A large number of pet food recalls in 2007 resulted in a decrease in trust in the pet food industry.

Today a growing number of class action lawsuits against pet food companies, for incorrect labeling of ingredients, falsely claiming to be made in the US or requiring prescriptions for diets that contain no drugs or other legally controlled substances, could indicate that distrust continues.

For complete details and up-to-date information on pet food recalls, visit the AVMA or FDA websites.

30 November 2016

HEALTH - First FDA Approved Drug for Dogs With Lymphoma

VetDC, a veterinary cancer therapeutics company, has completed the final steps towards U.S. Food and Drug Administration’s Center for Veterinary Medicine (FDA-CVM) approval for Tanovea™.

Tanovea™ (rabacfosadine for injection) is a novel small molecule drug designed to preferentially target and attack cancer cells implicated in lymphoma, one of the most common cancers seen in companion animals.

In multiple clinical studies in over 300 client-owned dogs with naturally occurring lymphoma, Tanovea has consistently demonstrated robust anti-tumor activity in both naïve and relapsed cases, with a generally well-tolerated safety profile.

Tanovea would be an every-three-week treatment (via intravenous) for up to five doses.

This represents a substantial reduction in client visits relative to non-approved, ‘human’ generic multi-agent chemotherapy regimens commonly utilized in dogs with lymphoma.

“This is an incredibly exciting time for VetDC, as we are now in the home stretch toward introducing the first FDA-approved drug for use in dogs with lymphoma, one of the most common cancers affecting pets today,” Steven Roy, VetDC’s President and CEO, said in a release.

A decision is anticipated within 60 days and upon FDA approval, VetDC intends to begin commercialization in early 2017.


11 October 2016

HEALTH - Veterinary Feed Directive to Control Antibiotic Use

Farmers in many fields – raising everything from cattle to chickens and even bees – are anxious to see how a new federal feed directive will impact operations.

Set to take effect January 1, 2017, the rules will make it more difficult to get antibiotics for livestock but at the same time offer veterinary supervision to hopefully limit the amount consumed by humans.

“Essentially, the directive is an attempt by the U.S. Food and Drug Administration to reduce the amount of antibiotics fed to animals that could potentially end up in the human food supply,” a Utah-based Daily Herald article states.

All producers raising animals for human consumption regardless of operation size must comply.

The rules will also require a relationship to be forged between livestock producers and vets when it comes to acquiring medicated food used to treat animals for illnesses including pneumonia and mastitis (an inflammation of the mammary glands which can lead to infection and see a reduction in milk production) the Herald states.

Many in the industry are scrambling to ensure those affected will be prepared when the rules take effect and not blind-sided when looking to access antibiotics for animals.

The new regulations also mean medicated feed can no longer be used to create weight gain but only for medicinal purposes – disease prevention and control.

Currently, livestock owners can get medicated food directly from a feed store but next year it will no longer be legal for them to sell medicated feed without a written directive from a vet.

Some fear that mandating an order be written by a veterinarian will be cumbersome and cause delays, of several days, in the process of getting medication to an animal.

Growing pains are anticipated.

“Most veterinarians aren’t accustomed to the dosages and feeding rates and feeding lengths of time, so there’s going to be a little bit of struggle with that,” Marty Short, general manager of the North Region Feed Mill told the Daily Herald.

According to the Centers for Disease Control at least two million people in the U.S are infected annually by bacteria resistant to antibiotic treatment and more than 20,000 die from these infections.

The major push behind the directive is “to mandate judicious antibiotic use in livestock to reduce the risk of antibiotic resistant bacteria.”

And there appears to be an appetite among would-be consumers to make meat antibiotic free.

A & W, for instance, heavily advertises the fact they no longer have antibiotics (nor hormones or preservatives) in their beef.

While the amount and type of hormones used in meat is closely regulated by Health Canada and the U.S Food and Drug Administration, the issue of antibiotics in farm animals' food supply has been one leading to warnings from health officials both sides of the border.

Canadian officials and the U.S. Centers for Disease Control caution the “growing use of antibiotics in farm animals' food supply is worsening the problem of antimicrobial resistance – the phenomenon of bacteria becoming immune to antibiotics,” a Huffington Post article stated.

Short says, ideally the directive will shed a positive light on the industry in the eyes of consumers.

“The whole process can be a positive for us in improving consumer perception,” he told the Daily Herald.

“Even though most of us feel these things have been judiciously used in most cases, consumers do see a need for it and we need to respond to consumer concerns and we need to take this seriously and do the best we can to comply with these rules.”

Of course, there are glitches yet to be worked out as the directive is rolled out.

Utah beekeepers, for instance, could see operations complicated given most veterinarians – required to write the directives – do not prescribe to bees, David Wilson, a dairy extension veterinarian at Utah State University told the Daily Herald.

“In order to get the antibiotic-medicated cakes, somebody's going to have to become the bee vet,” he said.

Many argue that large-scale meat production relies on antibiotics to keep animals healthy and, according to a CBS report, some studies suggest the risk to humans consuming animals who have been treated with antibiotics is extremely low.

Others contend the “overuse of antibiotics in humans – not animals – (is) causing a rise in drug-resistant bacteria,” and a 2004 study showed “the likelihood that antibiotic would not work in a human due to animal use at 1 in 82 million.”

“The problem is not an animal or human issue per se,” Dr. Tom Chiller with the Centers for Disease Control and Prevention told CBS.

“It's about using the antibiotics as judiciously as we possibly can in situations where they are needed.”

By Nadia Moharib
Nadia is an animal lover who has adopted everything from birds to hamsters, salamanders, rabbits, fish and felines. She has written about all-things-pets for years and was a long-time editor of a pet magazine in a daily newspaper which featured a Q & A column, Ask Whit, penned by her pooch (ghost written, of course.) The serial dog owner lives in Calgary, Alberta and most days can be found at a dog park picking up after her rescue pooch, Scoots.

10 August 2016

RESEARCH - 'Natural' 'Humane' Food Labels Create Confusion

A recent survey by Lake Research Partners shows that even though 77% of American consumers are concerned about the welfare of farm animals, there is significant confusion about how to make ethical purchases and what existing labelling means.

28% of consumers who are not paying attention to labels relating to welfare standards just don’t know what to look for. And even among those consumers who are paying attention, confusion about what the labels mean is a big problem.

For example, “free range” does not mean that the labeled product comes from an animal that spent most, or even much, of its time in a pasture.

There is no legal definition of “free range” for pork, beef, or dairy, and while there is a legal definition for poultry, it is far from what the label seems to indicate. In order to be labeled “free range,” it is only necessary for the birds to have had access to the outdoors, regardless of the size of that space, or how long they were allowed out.

Similarly, “humane” has no legal definition and producers can use it regardless of their farming practices, and “natural” only refers to how the meat is handled after slaughter.
This is a big problem both for consumers who want to support humane farming practices, and for producers who are holding themselves to higher standards.

75% of consumers in the survey also said they want independent inspectors and qualified third parties to ensure that the labels on products mean what they seem to imply.

This is an important take-away for stores and brands, and one way that producers who are aiming for higher standards can ensure that consumers are able to find and trust their products.

The Food and Drug Administration (FDA) defines ‘natural’ as “nothing artificial or synthetic,” such as color additives, has been added to a food that would not normally be expected to contain it. But that definition is over two decades old.

With a variety of class action suits accusing companies of misleading consumers by labeling foods containing artificial, synthetic or genetically modified ingredients as “all natural,” petitions from citizens and a number of federal court judges have called upon the FDA to update their definition.

As a result, the FDA collected comments on the use of this term in the labeling of human food products and are currently compiling the data.

Some certifications are currently available, such as the Animal Welfare Approved (AWA), Certified Humane (CH), or Global Animal Partnership (GAP) certifications. These organizations do provide the kind of independent inspection that consumers are starting to demand.

The Canadian Federation of Humane Societies has adopted the “Five Freedoms,” a concept originating in, and still used by, the UK government. But despite this, and the research that supports standards based on the Five Freedoms, there is still a lack of comprehensive, independent oversight in any of these jurisdictions.

As one way to address this issue the American SPCA has launched Shop With Your Heart, a resource guide that hopes to help consumers learn about farm animal welfare, understand existing labeling, find products that have a higher welfare standard, and even resources to help consumers request that supermarkets carry a wider variety of welfare-certified products.

By Tiffany Sostar
Tiffany is a writer, editor, academic, and animal lover who came late to her appreciation of pets. At 18, a rescue pup named Tasha saved her from a depression and she hasn't looked back. She has worked as the canine behaviour program coordinator for the Calgary Humane Society, and was a dog trainer specializing in working with fearful and reactive dogs for many years. She doesn't have any pets right now, but makes up for it by giving her petsitting clients (and any dogs she comes across on her frequent coffee shop adventures) extra snuggles.

17 June 2016

HEALTH - New Medication for Dogs with Noise Anxiety

It’s a common sight - Fido panting, trembling or running for cover when he hears loud noises like thunder or fireworks.

Noise aversion or anxiety has been treated with anti-anxiety medicine, tranquilizers and behaviour modification with mixed results.

Now pet owners have a new option - a gel medication that can be safely administered at home to help calm dogs without sedation. This allows dogs with noise aversion to remain calm yet fully functional.

Manufactured by Zoetis, SILEO is a gel formulation of dexmedetomidine, a highly selective alpha-2 adrenoceptor agonist that blocks norepinephrine release, a chemical in the brain that is involved with the development of fear and anxiety.

“We know that noise aversion has been difficult to treat, is stressful for pet owners and can be traumatic for their dogs. SILEO works the way veterinarians and pet owners need it to work, calming dogs while allowing them to interact normally with the family,” said Shelley L. Stanford, DVM, MS, MBA, group director, Companion Animal Veterinary Professional Services at Zoetis.

“It has rapid speed of onset, is easy to administer at home and works ‘in the moment,’ without any other treatments or training.”

SIELO is the first and only medication approved by the U.S. Food and Drug Administration (FDA) for treatment of noise aversion in dogs.

Each dose lasts two to three hours and takes effect within 30-60 minutes after application.

The first dose can be given as soon as the dog shows signs of anxiety and fear, or approximately 30–60 minutes before a known anxiety- or fear-causing noise stimulus, such as fireworks.