FDA Support – Page 6 – by Liberty Management Group Ltd.

Who needs to register with FDA?

Owners, operators or agent in-charge of domestic as well as foreign facilities that are engaged in manufacturing, processing, packing or holding for human or animal foods for consumption in USA are required to register with FDA unless exempt from the requirement to register under 21 CFR 1.226.

Facilities that are exempt are:

Farms
Restaurants
Retail Food Establishments e.g. grocery stores
Nonprofit Food Establishments
Fishing Vessels
Facilities that manufacture/process, pack, or hold food entering US solely for the purpose of exportation or trans-shipment to another country
Private residence of individuals
Post Offices, Freight Forwarders

While registering a facility with FDA, the owner, operator or agent in-charge is required to provide accurate Facility info including the names of Emergency contact, Products, Trade names under which it conducts business and US Agent for the purpose of FDA communications. Also, owner, operator, or agent in charge provides an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.

If a facility is required to register with FDA, they must register before beginning manufacturing, processing, packing, or holding operations in USA.

In addition to registration, all registered facilities are also required to renew FDA registration between Oct -Dec every even numbered year. FDA will consider a registration for a food facility to be expired if the registration is not renewed as required. Such registration will be cancelled and removed by FDA from its system.

Staring Oct 2020, FDA will mandate submission of UFI (Unique Facility Identifier) for all food facilities. This UFI will be required for all new registrations as well as registration renewals. FDA will not confirm your registration or provide you with a registration number until FDA verifies the accuracy of your facility’s UFI and verifies that the facility-specific address associated with the UFI is the same address associated with your registration.

Liberty Management Group Ltd provides assistance with FDA Registration, Biennial Renewals, US Agent service and many other FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: June 06, 2019

Dietary Supplement Advisory List

To market dietary supplements in US, manufacturers need to be FDA registered and ensure that their product ingredients are safe and approved by FDA.

In public interest, the FDA has unveiled an online tool, Dietary Supplement Ingredient Advisory List, that alerts the public when FDA identifies any ingredients that do not appear to be lawful ingredients in dietary supplements.

The new list can be used by consumers who do not wish to purchase any dietary supplements that contain questionable ingredients as well as manufacturers or distributors who wish to avoid selling supplements with such ingredients in their products.

Inclusion on the Dietary Supplement Ingredient Advisory List does not mean that FDA has determined the ingredient to be unsafe. Ingredients are added to this list on the basis of preliminary assessment enabling FDA to communicate to public while it completes a final determination regarding such ingredients. The reasons based on which an ingredient may be added to the list are:

The ingredients appear to be excluded from use in a dietary supplement
The ingredient does not appear to be a dietary ingredient, or does not appear to be an approved food additive or GRAS for use, or
The ingredient appears to be subject to the requirement for pre-market notification, but the requirement has not been met

The list is not exhaustive, and ingredients may be added to or removed from the list as and when FDA deems fit.

This new list is a step in the FDA’s ongoing effort to strengthen and regulate the dietary supplement market and better protect consumers from unsafe products.

To ensure that the ingredients that the manufacturers are adding to their products or planning to add to their products are safe and not questionable, an ingredient and label review service of LMG can be availed.

Liberty Management Group Ltd has been serving clients across the world with FDA registrations, label and ingredient compliance and many more FDA regulations. Our technical experts have in-depth knowledge of FDA regulations and guide you every step of the way regarding all FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: May 22, 2019

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

Accredited Third Party Certification Program

Accredited Third Party Certification Program was established under FDA’s FSMA (Food Safety Modernization Act). It is a voluntary program in which FDA recognizes accreditation bodies that will have the responsibility of accrediting third party certification bodies. Such certification bodies will conduct food safety audits and issue certifications to foreign food facilities. A certification body will conduct two kinds of audits: Consultative and Regulatory. A consultative audit will help foreign facilities prepare for a regulatory audit. If a regulatory audit determines that the facility is in compliance with US food safety requirements, the facility is awarded with a certification.

A certification body is required to report to FDA results of both types of audits immediately if serious risk to public health is predicted.

The certifications obtained through FDA’s Accredited Third-Party Program serves two purposes:

Importers can use a certification to establish eligibility to participate in Voluntary Qualified Importer Program (VQIP)
FDA can require certification as a condition of entry for specific imported food products.

An accreditation body has the followed duties under the Accredited Third-Party Certification Program:

Assess third party certification bodies competence if they can be accredited.
Monitor the performance of certification bodies it accredits and notify FDA of any change in their status.
Submit all data regarding certification bodies and its own performance to FDA

A certification body has the following duties:

Ensuring audit agents competence
Verify a facilities food safety plans effectiveness
Submit all data required by the program and report of its own performance to FDA.

Foreign governments, agencies or private third parties may apply to become accreditation bodies as well as certification bodies.

Requirements to become an Accreditation or Certification body:

Authority to assess third party for accreditation or conduct site audits and review records
Competency to have adequate finances, skills, resources and experience for operation.
A written quality assurance plan
Written measures to protect against conflicts of interest
Written procedures to establish, control and retain records.

FDA will post a notification on its webpage every time it recognizes an accreditation body and also when a certification body is accredited.

In March 2019, FDA’s accreditation body ANSI has accredited two third party certification bodies: SGS North America Inc of Rutherford, NJ and NSF Certification, LLC of Ann Arbor.

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 April 10, 2019

Trade Name vs Brand Name

A trade name is also known as DBA “Doing Business As”. If a company runs its business under more names than one, the names other than the legal registered name are called its trade names or DBAs.

On the other hand, a brand name is a name used by a manufacturer or organization for a product or service.

Every food facility marketing its products in US, whether domestic or foreign, must register with FDA all its addresses where it processes, manufactures, packs or stores its food products. An FDA registration is for a specific business address not for individual products. A company may select any number of product categories on a single registration of a business address but for each of its business locations it must have a separate registration.

Each facility is identified by its legal registered business name. This is the name on government forms and applications. If a company conducts business under different names, it does not need to complete registrations for each trade name separately. All alternate names under which it conducts business may be listed in one registration under section Trade Names. Brand names are not required to be included in a registration.

An example of above:

Company X Inc has one location where it manufactures and packs its food products and another location where it labels and stores these products before sending shipments to US. Company X Inc also runs its business under name EX. In this case, Company X Inc will have 2 registrations under its legal name – one for each location and will list its trade name EX as a Trade Name in both the registrations. In both registrations, it can list all its products and more, if it has any.

Once a company is registered, its clients may seek a certificate acknowledging that it is FDA registered and that the registration is valid.

For every registration completed by LMG, we issue a certificate of registration to our clients. All the trade names a facility uses to conduct its business may be listed on the certificate.

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 April 05, 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:

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.
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.
Certificate of Free Sale – This certificate is only available for dietary supplements, medical foods and special dietary use foods.
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:

The exporter can request an apostille or authentication from the U.S. Department of State, or
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