STAT News

OCTOBER 19, 2022

After years of deliberation, the FDA recently announced a new set of rules it proposes to regulate claims on food packaging that a product is “healthy.” ” The most basic rule: the product must actually contain food, not just ingredients.

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XTalks

JANUARY 26, 2023

The US Food and Drug Administration (FDA) has added sesame to its list of major allergens, making it easier for people with sesame allergies to safely consume packaged food without fear of an allergic reaction. Identifying which foods contain sesame is an important step in food safety and health care as an estimated 0.2

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XTalks

SEPTEMBER 24, 2020

Despite our best efforts to avoid added chemicals, the food and beverages we consume likely contain one or more of some 10,000 chemicals allowed to be added to foods. Related: FDA Issues First Injunction of its Product Safety Rule.

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Pharmaceutical Technology

MARCH 10, 2023

Freeze drying is a crucial technique to prolong the shelf life of pharmaceutical products. Also known as lyophilisation, the technique stabilises and preserves sensitive products such as biologics, and diagnostic kits, in a permanently storable state.

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Pharmaceutical Technology

JULY 29, 2022

This data has been shared with regulators, including the US Food and Drug Administration (FDA), and a request for US Emergency Use Authorisation (EUA) is planned. Regulators are well-disposed to these boosters. 1 sub-lineage on 19 July. Moderna ready to compete with Pfizer for new variant business.

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XTalks

JANUARY 17, 2023

The US Food and Drug Administration (FDA) has added sesame to its list of major allergens, making it easier for people with sesame allergies to safely consume packaged food without fear of an allergic reaction. Beginning this year, all food and dietary supplement manufacturers must clearly list sesame as an ingredient on product labels.

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XTalks

JANUARY 29, 2024

Although the medical device industry is dedicated to advancing healthcare innovation, pursuing environmental responsibility has encountered obstacles mainly due to rigorous regulations. Coloplast’s product portfolio includes Ostomy Care, Continence Care, Wound and Skin Care, Interventional Urology and Voice and Respiratory Care.

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XTalks

NOVEMBER 25, 2021

is recalling four lots of its injectable seizure medication levetiracetam over concerns of container closure integrity on vials of the drug product. Administration of a product that is not sterile may cause serious systemic infections that could pose to be life-threatening. Sagent Pharmaceuticals Inc.

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FDA Law Blog

OCTOBER 31, 2021

SB 343 adds additional requirements; it requires that California’s Department of Resources Recycling and Recovery (CalRecycle) update regulations that require disposal facilities to provide information on recycling data. g)(4) of the California Public Resources Code; or. g)(4) of the California Public Resources Code; or.

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FDA Law Blog

OCTOBER 5, 2022

It is focused on the nutrients in the food product rather than on it overall nutritional “quality.”. In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition.

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XTalks

APRIL 11, 2024

As a staple spice in many kitchens, the discovery of elevated lead levels in cinnamon products has prompted a closer look at food safety practices and regulations. Additionally, the processing of cinnamon, including drying, grinding and packaging, can introduce lead if the equipment or materials are contaminated.

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XTalks

JULY 27, 2022

Pink Sauce, a product created and marketed by a woman who goes by Chef Pii on TikTok, has gone viral for all the wrong reasons. Yet over the past few weeks, she’s faced numerous questions about Pink Sauce’s ingredients, packaging and marketing, prompting a social media-based food scandal. I don’t sell medical products.”

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XTalks

FEBRUARY 13, 2024

As food advertisements become more pervasive across various media, the potential for misleading claims about product quality, ingredients and health benefits also increases. Consumers felt misled by promotional images that depicted products as larger and more laden with ingredients than what was served.

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Camargo

NOVEMBER 15, 2021

It created the possibility of more easily obtaining information to support new product indications or to help with post-approval study requirements. In October, the FDA took a step towards clarifying these questions with a guidance called “ Data Standards for Drug and Biological Product Submissions Containing Real-World Data.”.

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XTalks

AUGUST 25, 2023

In the US, the primary agency responsible for regulating allergen labeling on food products is the US Food and Drug Administration (FDA). While this act is intended to make it easier for consumers with food allergies to identify potential allergens in the products they purchase, many believe it falls short.

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XTalks

SEPTEMBER 13, 2022

While the US Food and Drug Administration (FDA) would normally issue a recall, no recall was issued because the products are no longer available for purchase. The meal kits containing ground beef for this public health alert were shipped to consumers from July 2-21, 2022,” the FSIS stated in a public health alert.

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FDA Law Blog

JANUARY 3, 2024

Palmer & Riëtte van Laack — Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous. CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA).

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XTalks

DECEMBER 7, 2023

In the US, the regulation of food products, including the ban on certain items, falls primarily under the jurisdiction of two key agencies: the US Food and Drug Administration (FDA) and the US Department of Agriculture (USDA). In this episode of the Xtalks Food Podcast, Sydney talks about the top 10 foods banned in the US and why.

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XTalks

AUGUST 15, 2023

In a nation where the majority of store-bought food contain incomprehensible ingredients and employ labeling tactics designed to confuse consumers, understanding the nature of our snacks and meals can often prove difficult. Preservatives and additives serve as routine ingredients for manufacturers, extending the shelf-life of food products.

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XTalks

DECEMBER 20, 2021

Last Friday, The Coca-Cola Company issued a recall of some of its beverages because the affected products may contain pieces of metal bolts, washers or other foreign objects. Both the Minute Maid and Coca-Cola beverages are set to expire in 2022, which means consumers might still have products that contain the unspecified contaminants.

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XTalks

AUGUST 12, 2020

Up to half of all US consumers are confused by whole grain labeling on food products such as cereal, bread and crackers, causing them to make fewer healthy choices when shopping, according to a study published Monday by the journal Public Health Nutrition.

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FDA Law Blog

AUGUST 19, 2021

The latest version of the bill again directs FDA to establish a standard symbol system for front-of-package labeling for conventional foods. Regulation to establish levels of allulose, polydextrose, sugar alcohols or isolated fibers above which require a warning that the food contains levels that cause “deleterious health effects.”.

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The Pharma Data

OCTOBER 26, 2020

Under the terms of the agreement, Novasep will be in charge of developing and manufacturing (cell culture, AAV expression, purification, aseptic distribution and quality control) the two AAV vectors designed for the Sensorion OTOF-GT project and will supply Drug Product batches to support preclinical and clinical studies. Disclaimer.

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FDA Law Blog

SEPTEMBER 29, 2022

Plaintiffs challenged the use of the term bioengineered (rather than GMO or genetically engineered), the limitation of the mandatory disclosure being required only if the food contains detectable modified genetic material and the options of using a QR code disclosure or a text message for the disclosure statement.

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FDA Law Blog

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Test deployment for the changes listed above were deployed to eMDR on August 19, 2022 and will be deployed to production on March 17, 2023.

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Camargo

JUNE 4, 2021

Heron Therapeutic received FDA approval for its bupivacaine/meloxicam extended-release solution product to treat post-operative pain after total knee replacement, bunionectomy, and groin hernia repair. Because of the significant public health need, FDA granted this 505(b)(2) pathway product a fast track designation in late 2017.

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XTalks

JUNE 27, 2023

Food fraud refers to deliberate actions taken to deceive consumers for financial gain by misrepresenting the quality and composition of food products. Many individuals prefer products from reputable brands known for their high quality. Related: What is Food Fraud and How Can the Food Retail Industry Prevent It? What is Food Fraud?

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XTalks

MARCH 23, 2022

Since consumers are more health-conscious than ever, some food manufacturers are pulling out all the stops to convince people to purchase highly processed and unhealthy products with misleading food labeling. . Related: What Do Food Companies Mean When They Advertise Products as “Sustainable?”.

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XTalks

MAY 19, 2022

Mars Wrigley announced a voluntary recall of various candy products after consumers reported thin metal strands in the candy itself or loose in the bag. The products, which were recalled in the US, include Starburst, Skittles and Life Savers gummies. The Mars recall impacted 13 product stock keeping units (SKUs) ranging from 3.5-ounce

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XTalks

NOVEMBER 11, 2021

This exponential growth is especially true of meatless chicken products, which are growing at a rate of approximately 18 percent — more than four times higher than chicken from animals. Even if the word is followed by “vegan” or “plant-based,” meat producers believed there should be alternative names for foods that don’t contain meat.

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XTalks

AUGUST 31, 2020

Importation of contaminated food and food packaging is a feasible source for such outbreaks and a source of clusters within existing outbreaks,” according to the study’s abstract. And Vietnam, a country that had won praise for its aggressive measures in containing the virus, suffered scores of infections and ten deaths in August.

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XTalks

NOVEMBER 9, 2022

However, ultra-processed foods contain more artificial ingredients than those that just have added salt, sugar or oil. They usually have very few whole ingredients and contain flavorings, colorings or other additives.

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Pharmaceutical Technology

DECEMBER 9, 2022

M&A – Commended PRODUCT LAUNCHES – Commended RESEARCH AND DEVELOPMENT – Commende d. The company is ranked in the M&A, PRODUCT LAUNCHES and RESEARCH AND DEVELOPMENT categories in the 2022 Pharmaceutical Technology Excellence Rankings. Pharmaceutical Technology Excellence Rankings – The Verdict.

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XTalks

MAY 24, 2023

Manuka honey, a natural product renowned for its antibacterial and potential health benefits, has been at the center of a prolonged legal dispute between Australia and New Zealand. It underscores the complexities of trademarking food products, the influences of cultural heritage and the growing demand for authenticity.

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FDA Law Blog

AUGUST 17, 2023

FDA-2023-P-0313 and FDA-2023-P-0344 ) regarding its product Hetlioz (tasimelteon). Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. §

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XTalks

MAY 30, 2023

The patch itself is made of biodegradable nanocellulose and contains no plastic additives. The healthcare industry has one of the heaviest environmental footprints, and manufacturers are increasingly faced with regulations to make more sustainable products,” said Mohammad H. Behfar, senior scientist at VTT, in the news release.

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The Pharma Data

DECEMBER 30, 2020

Regulators said that the first dose of the vaccine had 70% effectiveness in protecting against COVID-19 in the period between the first dose taking effect and a second shot. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia,” the company said.

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