Tag: Label Compliance

INFANT FORMULA


US FDA regulates infant formula ensuring that it is safe and provides all the required nutrients for the healthy growth and development of infants.

The FDA regulatory requirements for infant formula are:

  1. FDA Registration: Manufacturers of infant formula are required to register with the FDA
  2. Infant formula notification: Before marketing a new or reformulated formula, manufacturers must submit a notification for FDA review of formulation & labeling of the products.
  3. Ingredients: Manufacturers must ensure that the formula provides the essentials nutrients to infants. FDA has established certain ingredient requirements. These requirements include the types and amounts of proteins, fats, carbohydrates, vitamins, and minerals that must be present.
  4. GMP – Infant formula manufacturers must adhere to GMP regulations to ensure the quality and safety of their products. This includes proper handling of raw materials, quality control testing, and sanitation procedures.
  5. Testing: Manufacturers are required to conduct appropriate tests to contain certain contaminants, such as microbiological contaminants, heavy metals, and pesticides, in infant formula and to ensure that their product meets FDA established safety standards.
  6. Labeling Requirements: Infant formula labels must be FDA compliant. The label must contain accurate & clear information about the products. Labels must include specific nutritional information, usage instructions, and warnings. Health claims and nutrient content claims are also subject to strict guidelines.
  7. Inspections and Audits: FDA conducts inspections of infant formula manufacturing facilities to verify compliance with regulations. Such inspections may occur regularly to ensure ongoing adherence to safety and quality standards.
  8. Recalls and Market Withdrawals: In the event of a safety concern or non-compliance with regulations, the FDA has the authority to request a recall or market withdrawal of infant formula to protect public health.

Liberty Management Group Ltd. can help you with FDA regulations.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

CBD in Foods and Dietary Supplements

There has been growing interest in the development of consumer products derived from cannabis and its components including CBD-Cannabidiol. FDA has found that many companies are marketing products containing CBD that may put consumers health at risk.

By far FDA has approved only one drug containing CBD for treatment of seizures. But FDA has found that many other CBD containing products are being sold in market, some as dietary supplements. As per FD&C Act, if a substance is an active ingredient (such as THC or CBD) in a drug that has been approved by FDA or is the subject of an IND – Investigational New Drug, for which substantial investigations have been instituted, then products containing such substance are excluded from the definition of dietary supplements. Exclusion from the definition of dietary supplement means that it is prohibited to market such products as dietary supplements.

If a product contains ingredients from such a part of cannabis plant that does not contain THC or CBD, then it may be marketed as a dietary supplement however it must comply with all applicable laws and regulations governing dietary supplement products. Such manufacturers who wish to market dietary supplement that contain new dietary ingredients that were not marketed in US before October 15, 1994 must notify FDA about these ingredients demonstrating that such supplement is safe under the conditions of recommended usage suggested in the labeling. In addition to NDI-New Dietary Ingredient notification, compliance to labeling and cGMP requirements specific to dietary supplements must be met.

If a non-THC or non-CBD ingredient derived from a cannabis plant is added to food products, such food ingredients are subject to premarket review and approval by FDA unless the substance is GRAS -Generally Recognized as Safe, by the experts under the conditions of its intended use. FDA has so far received and accepted only 3 GRAS notifications for hemp seed ingredients. Food companies that wish to use cannabis derived ingredients in their food products must abide by the laws and regulations including food additive petitions and GRAS notifications.

It is important to know the regulatory status of an ingredients that is added to any food or supplement. Liberty Management Group Ltd. can help you with Ingredient compliance, FDA registration, Label compliance and other FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: August 14, 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