Tag: Dietary supplement registration

How does FDA regulate Dietary Supplements?

Manufacturers and sellers of dietary supplements in the US must comply with various FDA requirements to ensure the safety, quality and labeling of products being offered for sale in the US.

Key FDA requirements are:

Facilities manufacturing, packing, or storing dietary supplements must register with the FDA. Registration helps the FDA identify and monitor industry participants. Registration must be renewed biennially, and any changes to facility information must be updated.

Dietary supplement labels must be truthful and not misleading. Labels must accurately represent the product’s ingredients, content, and intended use. A Supplement Facts panel must be included on the label, providing information on serving size, ingredients, and nutrient content per serving. Allergen labeling is required to inform consumers of the presence of major food allergens, if applicable. Dietary supplement manufacturers are prohibited to make drug claims such as treat, cure, diagnose, or prevent diseases.

  • Current Good Manufacturing Practices (GMP):

Dietary supplement manufacturers are required to follow GMP regulations. GMP regulations establish standards for the production, packaging, labeling, and storage of dietary supplements. Compliance with GMP helps ensure that dietary supplements are manufactured consistently and meet quality standards. Facilities must maintain detailed records and establish quality control procedures.

  • New Dietary Ingredients (NDIs):

Manufacturers intending to use a new dietary ingredient (an ingredient not marketed in the U.S. before October 15, 1994) must submit a notification to the FDA at least 75 days before marketing the product. The notification must include evidence demonstrating that the NDI is reasonably expected to be safe for use in dietary supplements.

  • Adverse Event Reporting:

Manufacturers and distributors of dietary supplements are required to submit reports to the FDA regarding any serious adverse events associated with their products.

  • Imports:

The FDA regulates imported dietary supplements to ensure they meet the same safety and labeling standards as domestically produced supplements. Imported supplements may be subject to inspection and testing at US ports of entry.

  • Enforcement:

The FDA can take enforcement actions against manufacturers and distributors that violate regulations, including issuing warning letters, initiating recalls, and seizing products.

Liberty Management Group Ltd. provides assistance with FDA registration and label compliance.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

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