30/03/2021

USA: FDA Announces Investigation into Real Water

 


The U.S. Food and Drug Administration (FDA) has announced an investigation into Real Water alkaline water, which is allegedly the link between several cases of acute non-viral hepatitis. The investigation comes amid the filing of several lawsuits alleging harm to consumers of the water, including children. The agency announced that Real Water was not cooperating with the investigation because it failed to provide records or access to facilities.

“The FDA is committed to protecting the health of Americans and is especially concerned when there is a food safety issue impacting our youngest, and some of the most vulnerable in the population – infants and young children,” a press release stated. “Upon learning about reports of acute non-viral hepatitis in Nevada, impacting five young children, the FDA quickly activated a team to further investigate. We are working closely with the CDC, state and local partners to complete our investigation and monitor for any additional illnesses.”

By Mark Anstoetter et al. [Shook, Hardy & Bacon L.L.P.].





18/03/2021

In brief: food and animal safety in USA

 

Food safety, certification programmes, animal safety and disease

Livestock legislation

Primary processors in the United States are subject to legislation governing their methods of treatment and slaughter of live animals. The Humane Methods of Slaughter Act (HMSA) governs the slaughter process itself. The HMSA enjoys some pre-emptive power over the states and is enforced by the US Department of Agriculture (USDA). Importantly, the HMSA does not apply to poultry slaughter.

Another principal piece of legislation in this area is the Federal Meat Inspection Act (FMIA). The FMIA confers broad authority onto the Food Safety and Inspection Service (FSIS), a federal agency within the USDA, to implement and enforce thorough inspection criteria for food processors. The FMIA applies to slaughterhouses that transport their products across state lines. A supplemental piece of legislation, the Wholesome Meat Act, requires all states to have intrastate inspection programmes ‘equal to’ that of the federal government. These laws work in tandem to create a national scheme of health and safety governance applicable to primary processors of most live animals. Relatedly, the Poultry Products Inspection Act (PPIA) imposes safe and humane slaughter and processing of poultry products.


Food safety regime


Different statutes regulate the safety and labelling of meat and poultry at the federal level. The FMIA and the PPIA regulate the production, safety and labelling of meat and poultry products, respectively, with few exceptions. Under the FMIA and the PPIA, and their implementing regulations and policy statements, the FSIS broadly regulates nearly all aspects of the harvest, processing and labelling of meat, poultry and certain egg products regulated under the Egg Products Inspection Act (EPIA). 

Two important concepts run through these regulatory schemes: adulteration and misbranding. Adulteration is the standard for food purity and safety, broadly defining which food products meet regulatory requirements and are safe for consumption. Misbranding relates to whether the labelling of a food meets regulatory requirements. The FSIS regulations, policy memoranda and the Food Standards and Labelling Policy Book provide additional labelling requirements and guidance for meat and poultry products.

Most food products are regulated under the Federal Food, Drug and Cosmetic Act (FDCA) administered by the Food and Drug Administration (FDA). Whole eggs in shells are regulated under the FDCA but other egg products are regulated under the EPIA, administered by the FSIS. Animal feed and pet food are also regulated under the FDCA as are dietary supplements, medical foods and infant formula, but with some additional requirements. Alcohol products are almost entirely regulated under the Federal Alcohol Administration Act, administered by the US Treasury Department’s Alcohol and Tobacco Tax and Trade Bureau. Organic food products are regulated under the Organic Food Production Act, administered by USDA.


Safety enforcement

The Food Safety Modernization Act (FSMA) imposes numerous food safety requirements on food companies, including a mandate that companies that manufacture, pack or hold food develop written food safety plans. These food safety plans include, among other things, a hazard analysis to identify reasonably foreseeable hazards to humans or animals and controls to minimise or prevent those hazards.


The FSMA arms the FDA with enhanced monitoring and enforcement powers, including the authority to issue a mandatory recall when there is ‘reasonable probability’ that a food is adulterated or misbranded and will cause serious adverse health consequences or death to humans or animals. The FDA rarely uses its recall power, instead using public announcements and other means to encourage a company to issue a voluntary recall. The FDA can suspend a facility’s registration, seize and detain food, and impose both civil and criminal liability for individuals or corporations that sell adulterated or misbranded products.

Regarding meat, poultry and eggs products, the FSIS has similar legal authority to take administrative, civil or criminal enforcement actions against individuals and companies for violations of the FMIA, the PPIS and the EPIA. These actions can include detention of products when there are insanitary conditions at a facility or inhumane slaughter or handling. Recalls are initiated by the manufacturer or distributor. At times, the FSIS recommends a company initiate a recall, but all recalls are voluntary. If a company refuses to initiate a voluntary recall, the FSIS has the legal authority to detain and seize those products in commerce. The FSIS can also stop facility production, seize product, file an injunction and seek civil or criminal penalties.

 

Product certification 
 

In the United States, third-party certifying organisations establish adherence to certain voluntary standards, such as organic certification and labelling and labelling products as ‘non-GMO’. Organic certification verifies that the company complies with USDA organic regulations and allows certified companies to label, market and sell products as organic.

Bioengineered foods are regulated by the USDA under the National Bioengineered Food Disclosure Standard of 2016. All bioengineered foods or foods containing bioengineered food ingredients must bear specific labelling by 1 January 2022. The bioengineering disclosure requirement does not address foods that claim to be ‘non-GMO’; this is a claim usually made with certification from a third party that the food is ‘non-GMO project verified’.

 

Food labelling requirements


Federal jurisdiction over food labelling is divided between two key agencies: the FDA and the USDA. The FDA governs most foods sold in the United States under the FDCA. The FDCA requires five mandatory label elements: product name; net contents; nutrition fact panel; ingredient list; and name and place of the manufacturer or distributor. Health claims (statements regarding how foods affect the ‘structure and function’ of the human body) and claims such as ‘light’, ‘fewer calories’, ‘less fat’, ‘fresh’, ‘bioengineered’, ‘pasteurized’, ‘organic’, ‘allergens’ and others are found in FDA regulations, guidance documents and compliance policy guides. In many cases, these regulations establish minute details of how text may appear on a label, including font size and placement.

Labelling of meat, poultry and certain egg products is regulated by the USDA’s FSIS. In contrast to products regulated by the FDA, labels for these products must be preapproved by the FSIS.

Labelling compliance is important; if the label fails to meet regulatory standards, the food may be characterised as ‘misbranded’ and subject to government enforcement actions ranging from warning letters to product recalls to product seizures. Misdemeanour or felony criminal penalties are also possible. However, perhaps the most discussed enforcement development in the last decade has been the growing trend of consumer class action lawsuits seeking substantial damages for labelling transgressions, both real and perceived.




Food animal legislation

 

The FSMA establishes robust, proactive food safety measures across the spectrum of industries that market food products to the public. It imposes safety and control requirements on the production of animal food, including food provided to food-producing animals, such as cattle and poultry.

A framework of federal statutory, regulatory and decisional law governs the transportation of food animals. For example, food animals’ health is protected during transportation by the ‘28 Hour Law’. Additionally, state negligence law often sets the standard for protecting food animals from exposure to contagions and other disease-causing stimuli.


Animal movement restrictions


Transportation of animals within the United States is subject to restrictions found at Title 49 of the US Code, section 80502 (West 2019). Known as the ‘28 Hour Law’, this federal statute prohibits the ‘confine[ment of] animals in a vehicle or vessel for more than 28 consecutive hours without unloading the animals for feeding, water, and rest’. The statute applies to:

  • rail carriers, express carriers and common carriers (except by air or water);
  • receivers, trustees or lessees of a carrier; and
  • owners or masters of vessels or vehicles transporting the animals.

 

There are exceptions, as follows:

  • the confinement period may be extended by an additional eight hours in two circumstances:
    • when the transported animals are sheep and the 28-hour maximum concludes at night; and
    • if the owner or custodian of the animals makes a separate request in writing for a time extension;
  • any animal may be confined in excess of 28 hours if unloading the animal cannot be accomplished safely in light of ‘accidental or unavoidable causes that could not have been anticipated or avoided when being careful’; and
  • the confinement period is inapplicable where the animals are transported by means that allow for food, water, space and an opportunity for rest.

 

Maximised confinement periods must be followed by five consecutive hours of release when food, water and rest are provided. Violations of the 28 Hour Law expose those bound by it to civil penalties ranging from US$100–US$500.

The Safe Air Travel for Animals Act governs the transportation of pets and other live animals through air travel.


Slaughter legislation


The regulations are primarily codified under Title 9 of the Code of Federal Regulations. The USDA’s virtual ‘National Agricultural Library’ houses pertinent statutory and regulatory law and explanatory secondary sources in a retrievable format. The Humane Methods of Slaughter Act, FSIS regulations and training materials and Government Accountability Office enforcement reports are accessible through the USDA’s library.


Pest control requirements


In the United States, the Environmental Protection Agency (EPA) regulates pesticides, with authority derived from the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). FIFRA operates as a registration statute and requires EPA approval and registration of pesticides prior to their sale, distribution or use in the United States. A party seeking to register a pesticide must submit certain categories of testing data to the EPA. In determining whether to register a pesticide, the EPA engages in a cost-benefit analysis of the pesticide’s intended uses, weighing the potential adverse effects on human health and the environment against the benefits of the intended use. Additionally, states may regulate the sale and use of pesticides if they do not allow a sale or use that is prohibited by FIFRA. States cannot impose labelling requirements in addition to or different from those required under FIFRA.

The FDCA will apply if pesticides are applied to food or food crops. Under the FDCA, as amended by the Food Quality Protection Act, the EPA must establish a maximum safe level, or tolerance, of pesticide residue depending on the type of crop. Statutes such as the Endangered Species Act, the Clean Water Act and the Safe Drinking Water Act apply generally to a broader category of chemical use and storage, but certain pesticides may be addressed specifically.

Source: Faegre Drinker Biddle & Reath LLP - Breia L. SchleussJacob D. Bylund, John P. Mandler and Sarah L. Brew






16/03/2021

Hungary: "BEER, BURGER, BARBECUE FESTIVAL" - Lack of distinctiveness of word combination

 


Hungarian applicant filed the combination word mark BEER, BURGER, BARBECUE FESTIVAL in Classes 32 (beer), 41 (festivals) and 43 (catering and similar services).

Decisions

The Hungarian Intellectual Property Office (HIPO) rejected the application, holding that it was descriptive. It referred to the European Court of Justice's (ECJ's) Biomild judgment (C-265/00), which held that word combinations which comprise the juxtaposition of several non-distinctive elements remain descriptive and cannot be considered unusual.

The applicant requested a review by the Metropolitan Tribunal, which was rejected. The tribunal agreed with the HIPO in respect of the lack of distinctiveness of the word combination for which the applicant had applied. Moreover, it held that the evidence that the applicant had filed was irrelevant in respect of distinctiveness. It did not prove acquired distinctiveness (ie, intensive use extended in time and space).

The applicant filed an appeal, but the Metropolitan Court of Appeal approved the tribunal's decision (8 Pkf 25 543/2018).

Comment

Distinctiveness is a basic requirement of the EU Trademark Directive (2015/2436/EU) and the EU Trademark Regulation (2017/1001). In the 18th century, long before the implementation of these rules, distinctiveness was also a key condition for trademark protection under US law and the laws of several European countries.

The situation is slightly different where trademark protection is required for a word combination. In this case, the HIPO referred to the ECJ's Biomild judgment as a precedent, which found that the addition of non-distinctive word elements cannot result in a distinctive sign. The same idea can be found in the ECJ's Postkantoor (post office) judgment (C-383/99).

A word combination that comprises terms which are not distinctive can be protected as a mark only if a surprising, unexpected sign is created. An example of such a linguistic effect can be found in the ECJ's Baby Dry judgment (C-383/74), which was quoted without reference in the HIPO's decision in this case. It is clear that it is not easy to create such a word composition.

It is also possible to acquire protection for a non-distinctive word combination if it has acquired a secondary meaning through successful use and publicity. In this case, the evidence filed in this respect was examined by the courts in both instances and found to be unconvincing.


Alexander Vida


Source: https://www.internationallawoffice.com/search?pd=2021-03-15T00%3A00%3A00.0000000Z&w=Intellectual+Property&j=Hungary&ac=true&ov=false

13/03/2021

List of shame

 


Non-exhaustive list of publishers that request articles, book chapters or presentations and then demand a payment (!) to publish it.



bhattacharya@healthj.org

radosevich@agriculturej.org

lydiajones@scisj.org

Functional Food Center <ffc@functionalfoodcenter.com>

Editor Granthaalayah <editor@granthaalayah.com>

Nutritionalbiochemistry <maryamnicolas2023@gmail.com>

Plant Science <plant@globalepisteme.com>

Vestrucci Paolo <vestrucci@agriculturej.org> NO ANSWER!

Philipp Aerni <philipp@sjofmat.org> NO ANSWER!



  • Danik (Martirosyan) Martirosyan
  •  contacto de 1er grado
  • Danik tiene una cuenta premium

President, Functional Food Center/Functional Food Institute 🤑🤑🤑🤑🤑🤑🤑🤑🤑🤑🤑🤑🤑


ding@educationj.org

abigailwilson@scieej.org

sharma@healthj.org

Chaturvedi Devdutt <chaturvedi@healthj.org>

Marc Rosen <marc@sjofbio.org>

nutrition@biomedscis.info

mitropoulos@clinicalmedicinej.org

albert@sjofs.org

ding@educationj.org NO ANSWER!

mitropoulos@clinicalmedicinej.org (in the blog "Flaky Academic Journals")

manfred@sjofco.org



Blacklist of the blog of deceptive alleged event organizers:

foodscience congress <congressfoodscience@gmail.com>

Food Research Webinar 2021 <foodresearch@crgmeetings.org>

NUTRICON Congress - 9-11 June 2021 - Call for Abstracts - Kakurinov Vladimir <kakurinov.vladimir@gmail.com>









See also: https://spamassassin.apache.org/



[If you receive this type of "spam", please communicate it to ceeudeco@yahoo.es]



11/03/2021

FDA Announces Increased Inspections and Enforcement Actions, Additional Guidance to Reduce Toxic Elements in Food for Babies and Young Children

 

On March 5, 2021, FDA issued a public statement announcing regulatory actions to reduce toxic elements — with a particular focus on arsenic, lead, cadmium and mercury — in food for babies and young children. FDA cited the risk heavy metals pose to infant and young children’s neurological development. The Agency indicated that it would take the following actions:

  • Issue guidance to develop action levels for contaminants such as heavy metals.
  • Increase inspections of facilities to ensure compliance.
  • Increase testing of foods for babies and young children.
  • Collaborate with academia, industry and government to support research of additional safety information on toxic elements in food for babies and young children and additional steps that industry can take to further reduce levels.

Background

In 2017, FDA established the Toxic Elements Working Group to reduce exposure to toxic elements (i.e., chemical hazards including heavy metals, mycotoxins and pesticides) in food, cosmetics and dietary supplements. Since that time, FDA has established a limited number of action levels for certain heavy metals listed in the table below.

Element/ProductAction Level
Inorganic arsenic in infant rice cereal100 ppb
Inorganic arsenic in apple juice10 ppb*
Lead in candy products for small children100 ppb (0.1 ppm)**
Lead in juices50 ppb**
*FDA Draft Guidance
**Recommended Threshold

February 4, 2020, report issued by U.S. House of Representatives Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy examined heavy metal levels in baby food products (the Report). The Report found high levels of heavy metals (inorganic arsenic, lead, cadmium and mercury) in the final products. The Report concluded baby foods are “tainted” with toxic heavy metals and criticized FDA’s lack of regulatory action on ensuring the safety of baby food.

The Report recommended FDA adopt the following actions:

  • Mandatory testing of finished products
  • Labeling: Require disclosure of heavy metal levels on food labels
  • Guidance: Establish maximum heavy metal levels across all baby food products to protect against neurological effects

In addition, the Report also recommended that the industry voluntarily find substitute ingredients or phase out products that contain ingredients that frequently test high in toxic heavy metals, such as rice.

In conjunction with FDA’s public statement, FDA issued a letter to industry on March 5, 2021, reminding baby and toddler food manufacturers and processors of the legal requirement to evaluate chemical hazards under FSMA’s Hazard Analysis and Preventive Control Rule (HARPC) and other hazard analyses as required by 21 CFR Parts 120 and 123 where applicable. To emphasize this enforcement priority, the letter cited a January 15, 2021, consent decree issued by the U.S. District Court for the Eastern District of Washington to Valley Processing, Inc. This order required the company to stop distributing adulterated juice products that contained inorganic arsenic and patulin toxins at levels that can pose health risks to consumers.

Implications for Industry: Toxic Elements Such as Heavy Metals are Potential Adulterants

FDA’s public statement and letter to industry clearly show that toxic elements in foods for babies and young children are an enforcement priority. Manufacturers and processors of these products should evaluate their supply chain and require Certificates of Analysis from ingredient suppliers demonstrating an absence of heavy metals and other chemicals of concern. In addition, it is advisable to reexamine HARPC and other hazard analyses to identify steps to reduce chemical hazards as well as conduct periodic final product testing.






09/03/2021

Labels, Italy seeks international allies against the Nutri-Score

 - Minister Patuanelli said this when speaking in Parliament -




"We are organizing together with some European countries that, like Italy, are fighting against the introduction of an absurd traffic light classification of front-pack nutrition labeling. This will be the best way to try to make a common front against who is probably guided by the companies you mentioned, which have an interest in obtaining an advantage in large-scale distribution for products that are not of our territory, but of another type". So Stefano Patuanelli, Minister of Agricultural Policies, answering the question time in the Senate chamber.

"I believe - he added - it is clear to everyone that this is unacceptable for our country and our productions, also because we have many local productions, such as DOP and IGP products, which by law must guarantee the presence of nutritional elements of a certain type and they certainly cannot comply with what is required to get the absurd green light. Some things have already been done. When I was Minister of Economic Development I was one of the signatories of the battery label proposal, which makes much more sense and clearly highlights the nutritional values of foods and those relating to daily needs".

According to Patuanelli "we must make the European Commission understand that what matters is to transmit the cultural values of healthy eating, which means that a glass of wine at the end of a meal is good for you, while a bottle and a half is not. This is the central theme and it cannot be a label on the bottle to say whether a food is bad or not at all, because this always depends on the way a person eats. We are deeply convinced of this and all together we must fight a strong battle in Europe (not only us as a country, but together with other countries that we are involving in this process) because if it is true, as it is true, that citizens and consumers have the right to know the nutritional values of the food they eat, it is equally true that this right must be guaranteed in the correct way and not to bring an unfair advantage to multinational producers".


Source: https://www.efanews.eu/item/17475-labels-italy-seeks-international-allies-against-the-nutri-score.html