Tag: FDA labels

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

ALPHA HYDROXY ACIDS

AHA are used in some cosmetics and drug products applied to the skin. Cosmetic products containing AHAs are marketed for a variety of purposes, such as smoothing fine lines, improving skin texture and tone, unblocking pores etc. AHA containing products cause exfoliation or shedding of the surface skin. The extent of exfoliation depends on the concentration of AHA and other ingredients in the product.

Some products that contain high concentration of AHAs or other acids act as skin peelers. Such products are regulated as drugs by FDA. For example, acne treatment products or skin lighteners are considered drugs. FDA has received many adverse reports for AHA containing products listing adverse reactions such as skin burning, peeling, rash, swelling, blisters, increased sunburn etc. FDA has found that applying AHAs to skin results in increased UV sensitivity.

FDA recommends using AHA containing products strictly according to the label directions. It is advisable to use skin protection. FDA also recommends that the labeling of a cosmetic product bear a statement that conveys the following information:

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

Liberty Management Group Ltd can help you make sure all elements of your product label are compliant to FDA regulations. LMG provides a wide range of services assisting companies with label compliance, ingredient compliance, FDA registration etc.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: August 29, 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:

  1. The ingredients appear to be excluded from use in a dietary supplement
  2. 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
  3. 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