Beginning September 8th 2014, the little ones in the U.S. would be dancing with joy for getting increased nutritional and safe milk formulas all thanks to the Food and Drug Administration (FDA). The agency has finally taken a vital step on Infant formula protections, considering the demands from various health sectors.

Though most manufacturers reportedly follow the Current Good Manufacturing Practices (CGMPs), the new rule will further push them to ensure adequate safety and nutritional supplement in the formulas.

With drastic improvements in the Regulatory Compliances paving the way for better consumer healthcare, the new rule will drive the companies to gear up to meet the new standards.

The truth behind the final decision

While mother’s milk is advisable for the infant growth, most of the parents in U.S. rely on infant formulas for additional nutrition. As per a survey, 1 million infants are fed formula from birth and 2.7 million from three months onwards.

Healthy infants are vulnerable to the effects of a nutritional insufficiency or deficiency in the diet. Indeed, the infants with inborn symptoms of metabolism imbalance, low birth weight, unusual medical or dietary problems, are at greater risk.

Since the infant formulas play a major role in the rapid growth of infants, the issue of amending the legislation has always been on the card. Going back to the legislative history, there have been many changes in the regulation after 1986 amendment of Infant Formula Act 1980.

With most of the mothers in U.S. inclining towards formulas than mother’s milk, the necessity for ensuring adequate nutrition was on the priority list for the agency.

While FDA has been planning to amend the regulations at the earliest, the public health policy demanded for enforcing more stringent laws in the infant formula production. Thus, the decision was on fast track to bring a wide smile on the future Americans.

Towards nurturing a healthier infant population

On February 10, 2014, FDA amended the infant formula regulations at 21 CFR Part 106 in the Interim Final Rule (IFR).

The IFR constitutes the requirements for

  • Current Good Manufacturing Practice (21 CFR part 106, subpart B)
  • Conduct of Audits (21 CFR part 106, subpart D)
  • Quality Factors (21 CFR part 106, subpart E)
  • Quality Control Procedures (21 CFR part 106, subpart C)
  • Records and Reports (21 CFR part 106, subpart F) and
  • Notifications for infant formula (21 CFR part 106, subpart G), as mandated by section 412 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)

With a mission of ensuring a healthy growth of infants, FDA announced the final step on IFR on June 9, 2014, considering the comments received after the first interim rule was published. The final rule for manufacturing compliance will be in effect from September 8, 2014 and the manufacturers in the U.S. have to standardize their production processes to meet the new terms.

Best Practices for healthy infant formula

Some of the best and fundamental practices in the final interim rule include:

  • Current good manufacturing practices specifically designed for infant formula, including required testing for the harmful pathogens (disease-causing bacteria) Salmonella and Cronobacter
  • A requirement that manufacturers demonstrate that the infant formulas they produce support normal physical growth
  • A requirement that infant formulas be tested for nutrient content in the final product stage, before entering the market, and at the end of the products’ shelf life


Curiously, the IFR is applied only to the formulas catered to the needs of healthy infants without any ex ceptional medical or dietary problems. As per FDA, many manufacturing companies in the U.S. market have been voluntarily following most of the CGMPs and Quality Control Procedures included in the final rule. However, as FDA ensures, the IFR will enforce the manufacturers to ensure additional safety and desired quality.

As per the regular practice, the infant formulas are never approved before they are marketed. However, all the formulas are expected to meet federal nutrient requirements, which are not changed by the new rule. Now, the manufacturers have to register with the FDA and provide a notification, before marketing a new formula.

Considering the new terms and conditions from FDA and the demand from public health policy for the safe and nutritional infant formulas, the manufacturers will now have to align with the final IFR while continuing with their voluntary implementations.

At the end, the young Americans will have the last laugh.


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