Tag: FDA registration

Food Labels

In order to market food products in USA, the manufacturers and distributors must be registered with FDA and their product labels must be FDA compliant.

FDA is responsible for assuring that foods sold in the United States are safe, wholesome and properly labeled. This applies to foods produced domestically, as well as foods from foreign countries.

FDA does not pre-approve product labels, so it is the responsibility of the food manufacturers to ensure compliance. To facilitate that, FDA has detailed comprehensive food labeling regulations. These regulations provide details on each required component of the product label such as Product Name, Type, Quantity, Manufacturers info, Serving size, Nutrition facts, Foreign language etc. The minutest details such as text type, font size, placement is detailed in the guidelines.

In 2016, FDA introduced a new Nutrition Facts Table for all packaged foods with an aim to provide the consumers with more information about the foods they eat and then make an informed decision about consuming them.

The new changes highlight the calorie and servings information along with declaration of the percentage daily values of essential nutrients. The new requirements also modified the footnote to Nutrition Facts Table explaining the meanings and importance of % Daily Values. Some nutrients have been made mandatory while others are made optional.

The new requirement also changes the serving size to what people are actually eating than what they should be eating.

Both foods manufactured as well as imported into US are required to abide by the FDA’s labelling regulations.

FDA has provided the following dates regarding compliance with above nutrition label changes:

January 1, 2020 – For manufacturers with USD 10 million or more in annual food sales

January 1, 2021 – For manufacturers with less than USD 10 million in annual food sales

Since manufacturers still have time to begin using the new and improved Nutrition Facts label, we can still see both label versions on the products in market. However, soon the adoption of new label will be mandatory for all.

The list of labeling requirements is long, and it becomes rather confusing and tiring to go through each one of them and ensure compliance. To ensure a 100% compliance, manufacturers and labelers can use LMG’s label review service. It is fast, effective and economical.

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

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on May 08, 2019

Dietary Supplements vs Drugs

FDA’s Dietary Supplement Health and Education Act (DSHEA) defines dietary supplements as products taken by mouth for supplementing the diet. Supplements include minerals, vitamins, proteins, amino acids, animal by products, extracts, herbals and botanicals. Supplements are not allowed to be marketed for the purpose of treating, preventing, curing or diagnosing diseases.

FDA regulates dietary supplements as special foods. The manufacturers of dietary supplements and dietary ingredients are required to register with FDA and select dietary supplement food category on their FDA registration. It is the responsibility of manufacturers and distributors of dietary supplements to make sure that the products are safe for consumption before they go on the market.

FDA does not approve dietary supplements or its ingredients. If a dietary supplement composes of a new ingredient, it is the responsibility of the manufacturer to notify FDA about the new ingredients prior to marketing the product. Such notification is reviewed by FDA for safety. FDA does not approve the effectiveness of the product.

On the other hand, drugs are regulated much more stringently by FDA. FDA defines drugs as any product that claims to diagnose, cure, treat, prevent or mitigate disease or affect the structure of the body. As per FDA a drug or its ingredients must be approved by FDA.

FDA has outlined detailed drug approval process in case of prescription and new drugs. A series of clinic trials and studies must be conducted to demonstrate the safety and effectiveness of a drug for each of it intended uses. FDA approval process is time consuming and expensive with no guarantee of success. Even for non-prescription drugs, FDA requires abidance to the pre-approved OTC monograph drug ingredients and comprehensive testing by the manufacturer of such products.

In brief, the general rule for supplements is that they are considered safe until proven unsafe while the drugs are considered unsafe until proven safe. FDA does not undergo any testing or trials before supplements are made available to consumers while a comprehensive evaluation process for medications including their packaging and manufacturing conditions is maintained in case of drugs before they are approved for marketing.

Liberty Management Group LTD is one of the leading FDA consulting groups in the USA. LMG provides assistance with Dietary Supplement Registration, Drug Registration, and many more FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: Aptil 24, 2019

FDA policy on Cosmetic recalls

What is a recall?

A recall is when a company withdraws its defective or contaminated products, from the market, that FDA considers to be in violation of laws, and that are likely to invoke a legal action such as seizure.

Role of FDA

Under FD&C Act, FDA does not have the authority to order a recall of cosmetic, but it may request a firm to do so. FDA is actively involved in:

  • Monitoring the progress of a recall by conducting own audit checks at wholesale or retail customers to verify the recall’s effectiveness.
  • Evaluating the product under recall and assigning a classification to indicate degree of hazard posed by the product.
  • Ensure a public notification is issued either by itself or by the firm.
  • Develop recall strategy or review one developed by the firm.
  • Ensure that the recalled products are destroyed or reconditioned suitably.

FDA classifies recalls under three categories:

  • Class I: for situations where products may cause serious health hazards or death
  • Class II: for situations where the product may cause temporary or medically reversible health consequence
  • Class III: for situations where product is not likely to cause adverse health consequences

Role of a Cosmetic Firm

When a product is found to be in violation, a cosmetic firm must:

  • Notify its customer
  • Notify FDA
  • Submit periodic recall status reports to appropriate FDA district office
  • Issue a public notification, if necessary
  • Destroy the products or act to bring them into compliance.

To minimize the damage caused by a product recall, a cosmetic firm must:

  • Prevent product adulteration and misbranding
  • Maintain a contingency plan in case a recall does happen
  • Assign production lot numbers to track the possible affected products
  • maintain adequate records to determine the location of products.

FDA has detailed regulatory procedures regarding what to expect if an FDA investigator conducts an inspection related to a recall. The objective of such inspection is to identify the root cause for the recall and to ensure that the firm has taken measures to prevent the reoccurrence of such problems and their cause. FDA takes the following steps:

  • Issue Notice of Inspection
  • Discuss problem with management
  • Investigate all circumstances which may affect products deficiency
  • Review records, logs for violative lots
  • Review firm’s quality control data
  • Determine if any actions are taken or planned to prevent similar occurrences.
  • Determine what actions are taken or planned for products still in commerce.

Liberty Management Group LTD  is one of the leading FDA consulting groups in the USA. LMG provides assistance registrations, labels, and many more FDA regulations.

Namrata Gusain

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on March 20, 2019

Export Certificates for Food Products

Firms exporting food products from the United States are often asked by foreign customers or foreign governments to supply a certificate from FDA for products regulated by it providing official assurance that products exported to their countries can be marketed in the United States.

Types of export certificates issued by FDA:

  1. Certificate to a Foreign Government – this certificate is available for conventional foods, food additives, food contact substances and infant formula products and states that a product may be marketed in and legally exported from US.
  2. Certificate of Exportability – this certificate is available for conventional foods, food additives, food contact substances and infant formula products that cannot be marketed in US legally but may be legally exported.
  3. Certificate of Free Sale – This certificate is only available for dietary supplements, medical foods and special dietary use foods.
  4. Health certificates for collagen and gelatin products intended for export to the EU and Specified risk materials certificates for collagen and gelatin products intended for export to non-EU countries.

FDA will not issue an Export Certificate if

  • FDA has initiated an enforcement action against the product
  • The manufacturing facility is not cGMP compliant
  • The manufacturing facility is not FDA Registered
  • The manufacturing facility for which FDA has no inspectional information.

The facilities registered and listed with FDA are checked for cGMP compliance under an FDA inspection. For Export Certificates, FDA would use inspection and all other available information regarding a product or facility to make an attestation of compliance with cGMP regulations.

FDA fee for “Certificate to Foreign Government” and “Certificate of Exportability” is, $ 175 for 1st certificate, $ 155 for 2nd certificate and $ 100 for each subsequent certificate.

FDA does not charge a fee for “Certificates of Free Sale” or for “Health Certificates”.

Some foreign governments may question authenticity of an export certificate. There are two ways to authenticate an export certificate:

  1. The exporter can request an apostille or authentication from the U.S. Department of State, or
  2. For electronically issued certificates issued after April 2016, an official of a foreign government can use the unique Certificate ID, printed in the top left corner of every certificate, to independently verify whether the export certificate was issued by FDA.

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

Namrata Gusain

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on March 13, 2019

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

PROHIBITED AND RESTRICTED INGREDIENTS IN COSMETICS

FDA Registration for Cosmetic Products and Cosmetic Establishments is voluntary and FDA does not approve cosmetic products or ingredients before they go on the market. It is the responsibility of cosmetic manufacturer to ensure the safety of its products.

As per FD&C, it is prohibited by law to distribute any cosmetic containing an ingredient that makes the product harmful when used exactly as per label directions or as per the customary use. The only exception to this rule is for coal tar hair dyes for which FDA cannot take action against as long as the product label contains a special warning statement and also contains directions for a skin test.

Color additives are permitted in cosmetics only if FDA has pre-approved them for the intended use.

FDA specifically prohibits or restricts following ingredients in cosmetics:

  • Bithionol – Prohibited as it may cause photo contact sensitization
  • Chlorofluorocarbon propellants – Prohibited for use in cosmetic aerosol products intended for domestic consumption
  • Chloroform – Prohibited as it causes cancer in animals and is likely to be harmful to human health, too. Except for residual amounts from its use as a processing solvent during manufacture, or as a byproduct from the synthesis of an ingredient
  • Halogenated salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide) – Prohibited as it may cause serious skin disorders.
  • Hexachlorophene – Prohibited because of its toxic effect and ability to penetrate human skin. The HCP concentration in a cosmetic may not exceed 0.1 percent, and it may not be used in cosmetics that are applied to mucous membranes, such as the lips
  • Mercury compounds – Restricted to eye area products at no more than 0.0065 percent of mercury calculated as the metal and is permitted only if no other effective and safe preservative is available
  • Methylene chloride – Prohibited as it causes cancer in animals and is likely to be harmful to human health, too
  • Prohibited cattle materials – These materials include specified risk materials, material from no ambulatory cattle, material from cattle not inspected and passed, or mechanically separated beef
  • Sunscreens in cosmetics
  • Vinyl chloride – Prohibited for use as an ingredient of aerosol products, because it causes cancer and other health problems
  • Zirconium-containing complexes – Prohibited in aerosol cosmetic products because of their toxic effect on lungs of animals, as well as the formation of granulomas in human skin

FDA may take action against any such cosmetic manufacturers or products on the market that do not comply with the law.

Cosmetic labels must always carry directions for use as some cosmetics are safe when used the correct way and unsafe when used the wrong way. Cosmetics must have any directions for use or warning statements needed to make sure people use the products safely. For example; some ingredients are safe on skin if washed off immediately but not if left on skin for hours or some ingredients that are safe for use on hair but not safe when used near eyes.

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

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on February 27, 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