Inspections, Compliance, Enforcement, and Criminal Investigations

Nestle Infant Nutrition 10/31/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
College Park, MD 20740 

OCT 31, 2014 

 
WARNING LETTER
 
VIA EXPRESS DELIVERY
 
Mr. Gary Tickle
President and CEO
Nestle Infant Nutrition
12 Vreeland Rd, 2nd Floor
Florham Park, NJ 07932-0697
 
Re: 441393
 
Dear Mr. Tickle:
 
The Food and Drug Administration (FDA or we) reviewed the label for your Gerber Good Start Gentle Infant Formula (23.2 ounce milk based powder) product in August 2014, which label directs consumers to your website at the Internet address www.gerber.com. We reviewed your website at www.gerber.com in October 2014. Based on our review, we have concluded that your Gerber Good Start Gentle Infant Formula (23.2 ounce milk based powder) is in violation of the Federal Food, Drug, and Cosmetic Act (the Act) [Title 21, United States Code (U.S.C.), sections 301 et seq.] and the applicable regulations found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
 
Your Gerber Good Start Gentle Infant Formula product is misbranded within the meaning of section 403(r)(1)(B) of the Act [21 U.S.C. § 343(r)(1)(B)] in that the labeling bears health claims that were not authorized by FDA. Your product is also misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is misleading.
 
Your product label bears a series of statements that, taken together, characterize the relationship of a nutrient to a disease or health-related condition. Your product label refers to your Gerber Good Start Gentle Infant Formula (23.2 ounce milk based powder) product as the “1st and ONLY Routine Formula TO REDUCE RISK OF DEVELOPING ALLERGIES.” Language next to this statement refers consumers to the inside label of the product for further information: “See Label Inside.” The inside label for the product includes the following statement: 
 
If you choose to introduce formula and have a family history of allergy, feeding a formula exclusively made with 100% whey partially hydrolyzed, like GOOD START Gentle formula, during the first 4 months of life may reduce the risk of atopic dermatitis* throughout the 1st year, compared to formulas made with intact cow’s milk protein. The scientific evidence for this is limited and not all babies will benefit.
*the most common allergy in infancy.
 
Underneath this statement appears the following language: “GOOD START Gentle formula should not be fed to infants who are allergic to milk or infants with existing milk allergy symptoms. Not for allergy treatment” (bold type in original).
 
Additionally, your website at www.gerber.com bears the following statement:
 
Comfort Proteins are easy for your baby to digest and may also provide protective benefits. Certain formulas made from 100% whey protein partially hydrolyzed—like milk-based GOOD START formulas—may reduce the risk of Atopic Dermatitis throughout the first year of life, compared to formulas made with intact cow’s milk protein.**
 
The double asterisk is linked to the following statement, which appears in non-bold type: “**The scientific evidence is limited and not all babies will benefit. It is important to note that GOOD START formulas should not be fed to infants who are allergic to milk or to infants with existing milk allergy symptoms.”
 
A health claim expressly or by implication characterizes the relationship between a substance and a disease or health-related condition [21 CFR 101.14(a)(1)]. Substance means a specific food or component of food [21 CFR 101.14(a)(2)]. Your product label identifies your infant formula product generally as being used “to reduce risk of developing allergies.” Your product label and your website further assert that 100% whey partially hydrolyzed may reduce the risk of atopic dermatitis. Infant formulas are foods as defined in section 201(z) of the Act [21 U.S.C. § 321(z)], and partially hydrolyzed whey protein is an ingredient of infant formula, and thus a component of food. Your product as a whole and the 100 percent partially hydrolyzed whey that is a component of the product are substances within the meaning of 21 CFR 101.14(a)(2), and your label and website characterize the relationship of these substances to a disease or health-related condition (i.e., allergies, atopic dermatitis). Because the product label and your website bear health claims that were not authorized by FDA, the product is misbranded within the meaning of section 403(r)(1)(B) of the Act.
 
We have previously considered and denied a petition requesting authorization to make a qualified health claim characterizing the relationship between the consumption of 100% partially hydrolyzed whey protein infant formula and reduced risk of food allergy in infants.[1] After reviewing the petition, the scientific evidence submitted with the petition, and other pertinent scientific evidence and information, FDA concluded that there is no credible evidence to support a qualified health claim relating the consumption of 100 percent whey protein partially hydrolyzed to a reduced risk of food allergy in infants. We are aware of no such credible evidence that has been developed since the time the petition was denied that would provide support for making a claim characterizing the relationship between the consumption of 100% partially hydrolyzed whey protein infant formula and reduced risk of food allergy in infants. If you are aware of additional evidence that would support a health claim by regulation or a qualified health claim, we encourage you to submit a petition pursuant to section 403(r)(4) of the Act [21 U.S.C. § 343(r)(4)]; see also FDA’s guidance on qualified health claims, which includes the procedures for submitting qualified health claim petitions.[2]
 
Additionally, in a May 24, 2011, letter announcing that FDA would consider the exercise of enforcement discretion,[3] we articulated four claims for which we intend to consider the exercise of enforcement discretion, each of which references the “very little scientific evidence” or “little scientific evidence” linking the consumption of 100% whey-protein partially hydrolyzed infant formula with a reduction in the risk of atopic dermatitis. In announcing our intention to consider the exercise of enforcement discretion, we explained that the use of any of the four specified claims would need to be accompanied by the following statement: 
 
Partially hydrolyzed formulas should not be fed to infants who are allergic to milk or to infants with existing milk allergy symptoms. If you suspect your baby is already allergic to milk, or if your baby is on a special formula for the treatment of allergy, your baby's care and feeding choices should be under a doctor's supervision.
 
(bold type in original). Though the claims on your product label and your website asserting the limited evidence linking the benefit between consumption of “100% whey partially hydrolyzed” and atopic dermatitis are generally consistent with the claims suggested in the 2011 letter announcing the claims for which FDA would consider the exercise of enforcement discretion, your label and website fail to include the following statement: “If you suspect your baby is already allergic to milk, or if your baby is on a special formula for the treatment of allergy, your baby’s care and feeding choices should be under a doctor’s supervision.” As discussed further below, this statement provides essential information necessary to ensure the safety of consumers. 
 
We further note that in your claim regarding atopic dermatitis that appears on your product label and your website, the substance characterized as having a relationship with atopic dermatitis is identified as a feeding formula exclusively made with “100% whey partially hydrolyzed.” The substance that was the subject of the 2011 letter announcing that FDA would consider the exercise of enforcement discretion was an infant formula exclusively made with 100% whey-protein partially hydrolyzed. An infant formula made with 100% whey-protein partially hydrolyzed is not the same as an infant formula made with 100% whey partially hydrolyzed because whey-protein and whey are different substances. Whey is the liquid obtained by separating the coagulum from milk, cream, and/or skim milk in cheese making and that is rich in lactose, minerals, vitamins, protein, and fat.[4], [5] In contrast, “whey protein” is a mix of globular proteins (i.e., alpha-lactalbumin and beta-lactoglubulin) that are separated from “whey” into concentrate, isolate, or hydrolysate forms.[6] Evidence reviewed in our 2011 letter announcing our intention to consider the exercise of enforcement discretion for the qualified health claim on atopic dermatitis relied on studies that used formulas containing 100% whey-protein partially hydrolyzed. In addition, Gerber’s Good Start Gentle Infant Formula label lists whey-protein concentrate as the first ingredient in the ingredient statement. As presently worded, “whey partially hydrolyzed” suggests to the consumer that the partial hydrolysis of whey could refer to any or all of the components in whey being hydrolyzed (i.e., oligosaccharides, fats, and protein), and we have seen no evidence to support the relationship between risk of atopic dermatitis and oligosaccharides, fats, and proteins, except for 100% whey-protein partially hydrolyzed. For all of the above-noted reasons, your product is misbranded within the meaning of section 403(r)(1)(B) of the Act.
 
Your product is also misbranded within the meaning of section 403(a)(1) of the Act, in that the labeling is misleading. Under section 201(n) of the Act [21 U.S.C. § 321(n)], one consideration in determining whether a product’s labeling is misleading is the extent to which the labeling fails to reveal facts material in the light of such representations with respect to consequences which may result from the use of the article under the conditions of use prescribed in the labeling or under such conditions of use as are customary or usual. The labeling of your Gerber Good Start Gentle Infant Formula product and your website are misleading within the meaning of section 201(n) of the Act because your label and website each contain a qualified health claim regarding 100% whey protein partially hydrolyzed infant formula and atopic dermatitis, but neither your product label nor your website provide a statement regarding the need for parents of infants who are allergic or suspected to be allergic to milk to consult with a doctor regarding the baby’s care and feeding choices.
 
As explained in the 2011 letter announcing that FDA would consider the exercise of enforcement discretion, without this information, the agency considers the use of a claim characterizing the relationship between 100% whey-protein partially hydrolyzed infant formula and atopic dermatitis to be misleading under sections 403(a)(1) and 201(n) of the Act, because it would fail to reveal facts material in the light of the representations being made and facts material with respect to consequences which may result from the use of these formulas. We consider the need for a statement advising consumers with infants suspected of having a milk allergy of the need for a doctor’s supervision to be a necessary factor to prevent the qualified health claim regarding 100% whey protein partially hydrolyzed infant formula and atopic dermatitis from being misleading. Your label and website include the sentence regarding milk-sensitive infants (“Partially hydrolyzed formulas should not be fed to infants who are allergic to milk or to infants with existing milk allergy symptoms”), but neither provides the statement that a baby’s care and feeding choices should be made under a doctor’s supervision if the parent suspects that their infant is allergic to milk or if their infant is being fed a special formula for the treatment of allergy. Studies show that one hundred percent whey-protein partially hydrolyzed infant formulas may cause allergic reactions in a significant percentage of infants allergic to milk. Such reactions can be serious and even life threatening, and feeding decisions in infants at risk for atopic dermatitis are most appropriately made under the guidance of a qualified healthcare professional. 
 
Your website also fails to include the following information in bold type: “should not be fed to infants who are allergic to milk or to infants with existing milk allergy symptoms.” As explained in the 2011 letter announcing that FDA would consider the exercise of enforcement discretion, the use of bold type is necessary in light of the significant public health risk that would be created by the feeding of these formulas to infants who are allergic to milk or to infants with existing milk allergy symptoms, and the fact that the articulation of a relationship between the consumption of 100% whey-protein partially hydrolyzed infant formula and a reduced risk of developing the allergic disease of atopic dermatitis could mislead consumers to think that these formulas are an appropriate choice for such infants. Therefore, because essential information is not included on the product label and other essential information is not displayed in a sufficiently prominent manner, this product is misbranded within the meaning of section 403(a)(1) of the Act because its labeling is misleading.
 
The above violations are not intended to be an all-inclusive list of deficiencies associated with your products or their labeling. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations.
 
You should take prompt action to correct the violations described above. Failure to promptly correct the violations may result in legal action without further notice, such as seizure or injunction. 
 
We also have a comment regarding the following claims that can be found on your website at www.gerber.com:
 
  • “Atopic Dermatitis (aka eczema) is a chronic skin condition that affects nearly 1 in 5 babies by six months of age. If your baby is not exclusively breastfed starting her on a formula like GERBER GOOD START Gentle may reduce the risk of atopic dermatitis, the most common skin allergy in infants.*” The asterisk links to a separate portion of the website with one of the qualified health claims for which FDA has announced that we will consider the exercise of enforcement discretion.
  • “100% whey partially hydrolyzed formulas may help reduce the risk of your baby developing atopic dermatitis, a type of allergic skin rash, when fed exclusively as a starter formula or as a supplement to breast milk when compared to intact cow’s milk protein formulas.**” The double asterisk links to a separate portion of the website with one of the qualified health claims for which FDA has announced that we will consider the exercise of enforcement discretion.
 
There is no provision in FDA’s 2011 letter announcing our consideration of the exercise of enforcement discretion that provides for separating the qualification language from the substance/disease link in the manner done on your webpage. We have concerns regarding the consumer’s understanding of the limitations of the science with regard to how the information in this qualified health claim is separately displayed. We encourage you to provide any consumer studies you may have that demonstrate that consumers understand the connection between the statements in spite of the separate manner in which the statements are displayed on your website.
 
Please respond to this letter within 15 working days from receipt with the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violations and steps being taken to prevent the occurrence of similar violations. Include any documentation necessary to show that correction has been achieved. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction.
 
Please send your reply to the U.S. Food and Drug Administration, Attention: Carrie Lawlor, Compliance Officer, Division of Enforcement, Office of Compliance, 5100 Paint Branch Parkway, College Park, MD 20740. You may also contact Ms. Lawlor via email at Carrie.Lawlor@fda.hhs.gov if you have any questions about this letter.                               
 
Sincerely,
 
/S/
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety
      and Applied Nutrition
 
 
cc: FDA New Jersey District
 

[1] See Qualified Health Claims: Letter of Denial – 100 percent Partially Hydrolyzed Whey Protein in Infant Formula and Reduced risk of Food Allergy in Infants (Docket No. 2005Q-0298) (May 11, 2006), available at http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm073313.htm.
[4] 2014 Food Chemicals Codex 9th Edition, Monograph
[5]http://www.merriam-webster.com/dictionary/whey
[6] 2014 Food Chemicals Codex 9th Edition, Whey Protein Concentrate Monograph

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