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Enforcement Actions

Nestle Healthcare Nutrition, 12/3/09

   

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

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

DEC 03 2009


David Yates
President
Nestle HealthCare Nutrition
10801 Red Circle Drive
Minnetonka, Minnesota 55343

WARNING LETTER

Re: CFSAN-OC-10-04

Dear Mr. Yates:

This is to advise you that the Food and Drug Administration (FDA) reviewed your websites at the Internet addresses http://www.Nestle-Nutrition.com, www.NestleNutritionStore.com, and http://www.kidessentials.com in November 2009. Your BOOST Kid Essentials Nutritionally Complete Drink (Vanilla, Chocolate, and Strawberry flavors) is promoted on your websites as a "medical food," and the labeling claims on your websites represent the product as a medical food for the medical condition of "failure to thrive" and also for "pre/post surgery, injury or trauma, chronic illnesses." As discussed further below, this product is misbranded under Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(a)(1)], because the label is false or misleading in that the product is labeled and marketed as a medical food but does not meet the statutory definition of a medical food in the Orphan Drug Act [21 U.S.C. § 360ee(b)(3)] or the criteria set forth in 21 C.F.R. 101.9(j)(8). Furthermore, this product is promoted for conditions that cause it to be a drug under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of this product with these claims violates the Act.

Misbranded Food

The Orphan Drug Act defines "medical food" as "a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation." The regulation in 21 C.F.R. 101.9(j)(8) sets forth criteria to clarify the statutory definition of a medical food. Specifically, this regulation provides that a food is a medical food only if:

i. It is a specially formulated and processed product (as opposed to a naturally occurring foodstuff used in its natural state) for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding tube;
ii. It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone;
iii. It provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation;
iv. It is intended to be used under medical supervision; and
v. It is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.

FDA considers the statutory definition of "medical food" to narrowly constrain the types of products that fit within this category.1 In addition to other criteria, medical foods must be for the dietary management of a specific disorder, disease, or condition for which there are distinctive nutritional requirements and must be intended to be used under medical supervision.2 Patients with such a disorder, disease, or condition must have a limited capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or have other special medically determined nutrient requirements, which cannot be managed by the modification of the normal diet alone.3 Medical foods are not those simply recommended by a physician as part of an overall diet to reduce the risk of a disease or condition.4 As discussed further below, your BOOST Kid Essentials Nutritionally Complete Drink product as reviewed on the aforementioned websites does not meet the regulatory criteria for a medical food.

There is no evidence that patients with the medical condition of "failure to thrive" have distinctive nutritional requirements or unique nutrient needs, as required by the statute and by 21 C.F.R. 101.9(j)(8). This condition could arise due to a number of reasons, including inappropriate dietary intake or defective utilization by the body. Because of this, the nutritional requirements and nutrient needs of individuals with this condition vary widely among patients. In addition, there is no distinctive nutritional requirement for "pre/post surgery, injury or trauma, chronic illnesses," as the nutritional requirements of individuals with these conditions vary greatly based on the specific circumstances of each individual.

No established distinctive nutritional requirement exists for the conditions for which your product is promoted as a medical food, and your BOOST Kid Essentials Nutritionally Complete Drink product therefore does not meet the statutory or regulatory definition of a medical food. Accordingly, your product is misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because the label is false or misleading in that the product is labeled as a medical food but does not meet the definition of a medical food.

New Drug

Under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)], articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease are drugs. The therapeutic claims on your websites establish that your BOOST Kid Essentials Nutritionally Complete
Drink product is intended to be used as a drug. The marketing of this product with these claims violates the Act.

Specific examples of claims in your product labeling that promote your product as a drug are as follows:

• "[F]or pre/post surgery, injury or trauma, chronic illnesses ...."
• "Lactobacillus [an ingredient in your product] is one of the most widely studied genera
of probiotics, proving numerous health benefits across many illnesses."
• "If your child has stomach problems, such as diarrhea caused by antibiotics, probiotics [an ingredient in your product] may help rebuild a healthy colony of good bacteria ..."
• "Antioxidants [found in your product] ... can help kids fight off sickness at school, the playground, at home, or anywhere on-the-go."
• "Clinical benefits include ... reducing number of days with viral diarrhea, reducing the risk of necrotizing enterocolitis (NEC) ...."

In addition, when scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product's intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered to be a claim about disease treatment or prevention if the citation refers to a disease use and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease. The following are examples of
reference citations used to market your product for disease treatment and prevention on your website:

• "Ivan A et al. Validation of the probiotic concept: Lactobacillus reuteri confers broad-spectrum protection against disease in humans and animals. Microbial Ecology in Health and Disease 2000;12(4)."

• "Johnston BC et al. Probiotics for the prevention of pediatric antibiotic-associated diarrhea (review). Cochrane Database Syst Rev 2007;2: 1-34."
• "Szajewska H et al. Probiotics in gastrointestinal diseases in children: hard and no-so-hard evidence of efficacy. J Pediatr Gastroenterol Nutr 2006;42(5):454-75."

• "Weizman Z et al. Effect of a probiotic infant formula on infections in child care centers: comparison of two probiotic agents. Pediatrics 2005;115:5-9."

Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, it is also a new drug under section 201(P) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the United States without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

The above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. It is your responsibility to ensure that all of your products are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct
these violations. Failure to promptly correct these violations may result in regulatory actions without further notice, such as seizure and/or injunction.

Please respond, in writing, within 15 working days from receipt of this letter. Your response should include 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 prevent similar violations. Include any documentation necessary to show that correction has been achieved. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Your response should be directed to Quyen Tien, Compliance Officer, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Compliance, Division of Enforcement, 5100 Paint Branch Parkway (HFS-608), College Park, Maryland 20740. If you have any questions regarding this letter, please contact Mr. Tien at the above address or by phone at 215-717-3705.

Sincerely,

/s/

Roberta F. Wagner
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
cc: FDA Minneapolis District Office

 

 

__________________

 

1 See 56 Fed. Reg. 60366, 60377 (Nov. 27, 1991); see also Guidance for Industry: Frequently Asked Questions About Medical Foods, May 2007.
2 See 21 U.S.C. § 360ee(b)(3); see also 56 Fed. Reg. at 60377.
3 See 21 C.F.R. 101.9(j)(8)(ii); see also 56 Fed. Reg. at 60377.
4 See 56 Fed. Reg. at 60377.