Showing posts with label INFANT FORMULA. Show all posts
Showing posts with label INFANT FORMULA. Show all posts

Tuesday, June 23, 2015

USDA ISSUES RULE ON ADDING SELENIUM TO INFANT FORMULA

FROM:  U.S. FOOD AND DRUG ADMINISTRATION
FDA Issues Final Rule to Add Selenium to List of Required Nutrients for Infant Formula
June 22, 2015

The U. S. Food and Drug Administration today announced a final rule to add selenium to the list of required nutrients for infant formula, and to establish both minimum and maximum levels of selenium in infant formula.

U.S. manufacturers began adding selenium to infant formula after the Institute of Medicine recognized selenium to be an essential nutrient for infants in 1989, and currently, all infant formulas on the U.S. market contain selenium. By amending regulations to add selenium to the list of required nutrients for infant formula and establish a safe range for this use, the FDA is able to require manufacturers currently marketing infant formula in the U.S. to add selenium within this safe range, and to require any manufacturer newly entering the U.S. market to adopt this practice as well.

Specifically, the rule requires 2.0 micrograms (μg) selenium/100 kilocalories as the minimum level and 7.0 μg/100 kilocalories as the maximum level of selenium in infant formula. It also amends the labeling requirements for infant formula to require the listing of selenium in micrograms per 100 kilocalories on infant formula labels.

Selenium, found in breast milk, is an essential nutrient for infants. Among its benefits, it helps the body defend against oxidative stress and aids in the regulation of thyroid hormones. Because infant formula often serves as a sole source of nutrition for infants, selenium in infant formula is needed to ensure that formula-fed infants are getting this essential nutrient at appropriate levels. Selenium is the 30th nutrient required by law to be in infant formula.

Monday, November 3, 2014

FTC ALLEGES GERBER FALSELY ADVERTISED GOOD START GENTLE FORMULA PRODUCTS

FROM:  U.S. FEDERAL TRADE COMMISSION 
FTC Charges Gerber with Falsely Advertising Its Good Start Gentle Formula Protects Infants from Developing Allergies

The Federal Trade Commission has charged Gerber Products Co., also doing business as Nestlé Nutrition, with deceptively advertising that feeding its Good Start Gentle formula to infants with a family history of allergies prevents or reduces the risk that they will develop allergies.

The agency also alleges that Gerber has falsely advertised Good Start Gentle’s health claims as FDA-approved. Through its federal court enforcement action, the Commission is seeking to prohibit Gerber from making the alleged false and unsubstantiated allergy-prevention claims.

“Parents trusted Gerber to tell the truth about the health benefits of its formula, and the company’s ads failed to live up to that trust,” said Jessica Rich, Director of the FTC’s Bureau of Consumer Protection. “Gerber didn’t have evidence to back up its claim that Good Start Gentle formula reduces the risk of babies developing their parents’ allergies.”

In its complaint, the FTC alleges that since 2011, Gerber has advertised its Good Start Gentle formula through advertisements that ran on television, in magazines, at point-of-sale displays, online, and in other promotional material. Good Start Gentle sells for about $24 for a 23.2-ounce package of powdered formula.

Good Start Gentle is made with partially hydrolyzed whey proteins (PHWP). Gerber claims that feeding babies this formula, instead of formula made with intact cow’s milk proteins, will prevent or reduce the risk that they will develop allergies. In its ads, Gerber promotes Good Start Gentle by saying, for example:

“You want your baby to have your imagination…Your smile…Your eyes…Not your allergies.”
Also, a sticker on the package states that Good Start Gentle Formula is the:

“1st & ONLY Routine Formula TO REDUCE THE RISK OF DEVELOPING ALLERGIES.”
The agency’s complaint charges that Gerber lacked the scientific substantiation to make these general allergy-prevention claims, in violation of the FTC Act.

In addition, according to the FTC, Gerber’s ads also misrepresent that Good Start Gentle has qualified or received approval for a Food and Drug Administration health claim. For example, some ads prominently featured a gold badge stating that Good Start Gentle is the “1st and Only” formula that “Meets FDA Qualified Health Claim.”

In 2009, Gerber petitioned the FDA for permission to make a claim connecting PWHP with the reduced risk of one type of allergy, atopic dermatitis, in infants. The FDA allowed Gerber to make the narrow claim but only if Gerber carefully qualified its statement to make it clear that there is “little scientific evidence” for the relationship.

The Commission vote authorizing staff to file the federal court complaint was 5-0. The complaint was filed in the U.S. District Court for the District of New Jersey on October 29, 2014.

NOTE: The Commission files a complaint when it has “reason to believe” that the law has been or is being violated and it appears to the Commission that a proceeding is in the public interest. The case will be decided by the court.

Search This Blog

Translate

White House.gov Press Office Feed