Namrata – Page 6 – FDA Support

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

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