Category: Food Regulations

FDA Import Alerts

An import alert is a notification from FDA to its field staff and public that the agency has substantial evidence on products that appear to be in violation of FDA regulations and that all future shipments of the such products are subject to Detention Without Physical Examination (DWPE) at the port of entry. These violations could be related to the product, manufacturer, shipper etc. Some examples of violations that may trigger import alerts are:

  • Product appears to be adulterated
  • Product appears to be misbranded
  • Manufactured, processed, or packed under insanitary conditions
  • The product is unapproved new drug
  • Foreign firm has refused FDA inspection
  • Forbidden or restricted for sale in the country in which it was produced or from which it was exported

Types of import alerts:

  • Country- or area-wide
  • Manufacturer/Product Specific
  • Shipper
  • Country/World Wide Alert

When FDA issues an import alert it is added to the red list. When the firms, products or countries have met the criteria for exemption from DWPE, they are added to green list. The firms, products or countries that are subject to intense surveillance or additional analyses are added to yellow list.

Every importer should check if the products being imported are subject to DWPE or not. Once a shipment is refused admission to the U.S., the importer has an opportunity to provide evidence to overcome the appearance of a violation. Such imported product, firm or country may remain in this status until FDA is convinced that the conditions to apparent violations have been resolved and that future entries will be FDA compliant.

Individual Import Alerts may include specific information regarding removal from DWPE. You should review the import alert specific to your alert and submit any and all documentation called for. You can access FDA’s Import Alerts here. FDA notifies the responsible parties that an imported product violates FDA regulations by issuing a Notice of Detention and Hearing. The notice provides a Respond By date to provide FDA with evidence to overcome the appearance of a violation.

Firms can seek expert guidance to make sure their product ingredients are approved and the labels are truthful and compliant with FDA regulations.

Liberty Management Group LTD  is one of the leading FDA consulting groups in USA. LMG provides guidance with FDA registrations, label and ingredient compliance, and many more FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on March 06, 2019

FSMA – PRODUCE SAFETY RULE

As per FDA about 48 million people get sick, 128000 are hospitalized and 3000 die every year from food borne illnesses. FSMA (Food Safety Modernization Act) was signed into law in 2011 by President Obama to reform America’s food safety system. It enables FDA to focus on preventing food problems rather than reacting to problems after they have already occurred.

To implement FSMA, FDA has finalized seven major rules which recognize that ensuring food safety is a shared responsibility among various points in the global supply chain for both human and animal food. One of the rules that takes care of farms is Produce Safety Rule, officially known as Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption.

Produce Safety Rule established science-based standards for safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption. The rule lays down preventative measures that would help bring significant benefits to consumers. The measures take care of:

  • Agricultural water
  • Farm workers training on health and hygiene
  • Biological soil amendments
  • Domesticated and wild animals’ control
  • Equipment, tools and building
  • Sprouts

Food safety risk is high for certain foods example leafy vegetables. In November 2018, several warnings were issued to consumers to avoid eating lettuce in US, as there was an E. coli outbreak linked to it, while there were investigations ongoing.

FDA has provided various compliance dates depending on the size of producer and type of produce.

FDA will begin routine inspections of large farms, other than sprouts operations, in spring 2019. The routine inspection of small farms will begin in spring 2020.

Farmers may refer to the draft guidance created by FDA to know how these requirements can be met.

Liberty Management Group LTD  is one of the leading FDA consulting group in the USA. LMG provides assistance with various FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on February 20, 2019

What are Food Additives?

Food Additives are substances the intended use of which results or may be expected to result, directly or indirectly, in its becoming a component of any food.

Direct Food Additives are any substances that are intentionally added to food to enhance or preserve its taste, texture, nutrition or appearance.

FDA registration is required for all domestic and foreign facilities that manufacturer, pack, label and store food additives. In addition all foreign facilities must also designate a US Agent for the purpose of FDA registration.

All food additives are deemed unsafe and are subject to premarket approval by FDA unless the substance is GRAS (Generally Recognized As Safe).

It is the responsibility of the food manufacturers to make sure that all ingredients in his products are approved and are used within the permissible limits of law. The regulatory status of a food is affected by the regulatory status of each food ingredient. The authorization is determined by the identity, properties and limitations of use. The regulatory status may be checked at the FDA website.

Food additives can be of various kinds such as; pH Control Agents, Anti-caking Agents, Emulsifiers, Humectants, Stabilizers, Thickeners and Gelling Agents, Leavening Agents etc.

To market a new food additive or before using an additive already approved for one use in another manner that is not yet approved, a manufacturer or other sponsor must either submit a Food Additive Petition or submit GRAS notification.

A Food Additive Petition is either approved or denied by FDA. If an additive is approved, FDA issues regulations that may include the types of foods in which it can be used, the maximum amounts that can be used, and how it should be appear on food labels.

Alternatively, a manufacturer may choose to go with GRAS notification. Under GRASN, a company notifies FDA that a particular use of a substance has been determined to be GRAS and provide the same type and quality of data to the agency as in the FAP process. FDA reviews the notification data but there is neither approval not denial.

Liberty Management Group LTD  is one of the leading FDA consulting group in the USA. LMG provides assistance with FDA registrations, Label Review and many more FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: February 14, 2019

Why is Prior Notice important?

Prior Notice is a notification issued to FDA prior to the importation of an article of food for human or animal consumption into USA. This includes 50 US states, District of Columbia, Puerto Rico only. The US territories are not covered under this definition.

Food that is imported with inadequate Prior Notice is subject to refusal and detention at the port of entry.

For Prior Notice, food includes all foods for human or animal consumption, irrespective of intended use.

Prior Notices are considered inadequate:

  • When there is either no prior notice submitted, or
  • The information submitted in prior notice is inaccurate, or
  • The prior notice is not submitted in accordance with required timeframes.

The requirement for prior notice is not based on the requirement of FDA registration. FDA registration is required for facilities that are engaged in manufacturing, processing, packing or holding of food for consumption in USA. Prior Notice is required for articles of food imported into US.

There are two online systems available that may be used to file Prior Notices namely., FDA’s PNSI and CBP’s ABI/ACS. For a prior notice submitted via CBP’s ABI/ACS, you may not submit prior notice more than 30 calendar days before the anticipated date of arrival. For a prior notice submitted via the FDA’s PNSI, you may not submit prior notice more than 15 calendar days before the anticipated date of arrival.

The requirement of Prior Notice does not apply to:

  • Food for personal use that accompanies the individual.
  • Home made food sent as personal gift to another individual in US.
  • Food that is imported & then exported and doesn’t not leave the port of arrival.
  • Meat and Poultry food products regulated exclusively by USDA.
  • Food brought in diplomatic bags.

Any person with knowledge of the required information may submit prior notice for an article of food being imported.

Timeframes for submitting Prior Notice:

For foods arriving by international mail –

  • For foods arriving by road, 2 hours before arrival;
  • For foods arriving by rail or by air, 4 hours before arrival;
  • For foods arriving by water, 8 hours before arrival

For foods arriving by Express Couriers like FEDEX – before the food is sent

Liberty Management Group LTD  is one of the leading FDA consulting groups in the USA. LMG provides assistance with Prior Notice, FDA registration and other FDA regulations.  

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: February 06, 2019

How Dietary Supplements are regulated by FDA?

Dietary supplements are regulated by FDA as special foods.

A dietary supplement is a product, taken by mouth, that contains a dietary ingredient intended to supplement the human diet. The DSHEA defines an ingredient, as dietary ingredient if it is one or a combination of the following substances; vitamins, minerals, herbs, amino acids, enzymes, extracts, or concentrates.

Under the DSHEA, it is the responsibility of the manufacturer of a dietary supplement to ensure that their product is safe before marketing in US.

FDA considers any dietary ingredient to be a New Dietary Ingredient if it was not marketed in the US as a dietary supplement before October 15, 1994. Such an ingredient cannot be used legally in a dietary supplement until the manufacturer or distributor submits an NDI (New Ingredient Notification) to FDA, at least 75 days before marketing this dietary supplement. An NDI includes details of what the dietary ingredient is and the history of its use or other evidence establishing that it can reasonably be expected to be safe.

For marketing dietary supplements in US, all dietary supplement facilities must beFDA registered and ensure that the product labels are compliant with FDA regulations. Foreign facilities are also required to designate a US Agent for FDA communications.

FDA has detailed labeling requirements specific to dietary supplements. Supplements are not permitted to make claims implying their use for the purpose of treating, diagnosing, preventing, or curing diseases.

Foreign dietary supplement facilities must also file a Prior Notice with FDA before their shipment enters US. Failure to issue a Prior Notice will result in detainment of shipment.

Liberty Management Group LTD  is one of the leading FDA consulting group in the USA. LMG provides assistance with Registration, US Agent Service, Prior Notice, Label Review and many more FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: January 16, 2019

FDA LACF Registration

All food facilities engaged in manufacturing, packing, labeling or holding of food for consumption in US must be FDA registered. In addition all foreign facilities must designate a US Agent for the purpose of FDA communications.

In addition, all commercial processors of low-acid and acidified foods located in the US and all foreign processors who export low-acid canned food (LACF) or acidified food products into the US must also register their processing plants (Food Canning Establishment Registration – FCE) and submit scheduled process filing with FDA.

LACF is any food with a finished equilibrium pH greater than 4.6 and a water activity greater than 0.85 excluding tomatoes and tomato products having a finished equilibrium pH less than 4.7.

An acidified food is a low-acid food to which acids are added and which has a finished equilibrium pH of 4.6 or below and a water activity greater than 0.85.

Any LACF food offered for import that is manufactured in a facility with no FCE registration will be refused admission into US. Wholesalers, distributors, broker and importers are not required to register or file processes. But they must ensure that their suppliers FCE registration is in order.

Any manufacturer that is required to register as an FCE must also submit its scheduled process for all of its Low Acid Canned foods to FDA to obtain a SID number for all such products. The manufacturer’s scheduled process must be reviewed and accepted by FDA before any such food is permitted to enter the US. The manufacturer must update the SID filing if there is any change in the manufacturing process, container type, size etc.

Liberty Management Group LTD  is one of the leading FDA consulting group in the USA. LMG provides assistance with Food Facility Registration, Food Canning Establishment Registration, Scheduled process filing and Label Review.  

   

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: January 9, 2019