Month: April 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