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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Natures One Inc 9/26/12

  

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

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

 

September 26, 2012
 
WARNING LETTER
 
VIA CERTIFIED MAIL
 
Jay C. Highman
President and CEO
Nature’s One
8754 Cotter Street
Lewis Center, OH 43035
 
Re: 335738
 
Dear Mr. Highman:
 
The Food and Drug Administration (FDA) conducted a review of your product labeling, including your internet website at www.naturesone.com, in August 2012Based on our review, we have concluded that your Baby’s Only Organic Dairy Toddler Formula, Baby’s Only Organic LactoRelief Toddler Formula, Baby’s Only Organic Soy Toddler Formula, and Baby’s Only Organic Dairy with DHA & ARA Toddler Formula products are in violation of section 412 of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 350a]. You can find a copy of the Act through links on FDA’s Internet website at www.fda.gov.
 
Our review of your product labeling revealed that your Baby’s Only Organic Dairy Toddler Formula, Baby’s Only Organic LactoRelief Toddler Formula, Baby’s Only Organic Soy Toddler Formula, and Baby’s Only Organic Dairy with DHA & ARA Toddler Formula products are represented for use as infant formulas; however, your firm has not provided new infant formula notifications for these products as required by section 412(c)(1) of the Act [21 U.S.C. § 350a(c)(1)]. Although your products are labeled as “Toddler” formulas, statements on the product labels and labeling represent that the products may be used as infant formulas as defined in section 201(z) of the Act [21 U.S.C. § 321(z)]. For example:
 
On your product labels:
 
  • The side panels of the product labels state that "Nature’s One recognizes that breast milk is the best source of nutrition a mother can provide her baby the first year of life and offers advantages not found in any formula.  Therefore, Baby's Only Organic is not intended for infants under 1 year of age unless specified by a healthcare professional."
  • The labels present nutrition information both in the Nutrition Facts panel and per 100 kilocalories, which is consistent with the requirements in 21 CFR 107.10(a) for declaration of nutrient information on infant formula.
 
At www.naturesone.com:
 
  • At the products' "Suggested Age and Use" links, the company (1) lists infants as one of two groups of suggested users (toddlers and infants); and, (2) says "for infants less than 12-months, use Baby's Only Organic as directed by a healthcare professional." 
  • Under the subheading "Infants" at the "Suggested Age and Use" links, consumers are advised to "print our nutritional comparison chart and present it to your doctor."  The nutritional comparison chart provides comparisons between your Baby’s Only Organic formula products, the nutritional requirements for infant formula defined by FDA, and the nutrient contents of competitors’ infant formulas, including "Similac Advance," "Enfamil Premium" and "Similac Go & Grow."
  • At the Frequently Asked Questions links, your answer to the question "Can my infant use Baby's Only Organic toddler formula" includes the statement that "Nature’s One recognizes that breast milk is the best source of nutrition a mother can provide her baby the first year of life and offers advantages not found in any formula.  Therefore, Baby's Only Organic is not intended for infants under 1-year of age unless specified by a healthcare professional." 
 
These statements on your product labels and website labeling indicate your intent to market your Baby’s Only Organic Dairy Toddler Formula, Baby’s Only Organic LactoRelief Toddler Formula, Baby’s Only Organic Soy Toddler Formula, and Baby’s Only Organic Dairy with DHA & ARA Toddler Formula products as infant formulas. These products are also new infant formulas under section 412(c)(2) of the Act [21 U.S.C. § 350a(c)(2)], because you have not previously manufactured an infant formula. A person who introduces a new infant formula into interstate commerce must make a submission that complies with section 412(d)(1) of the Act [21 U.S.C. § 350a(d)(1)]. The failure to make such a submission at least 90 days prior to marketing a new infant formula is a violation of section 412(c)(1)(B) of the Act [21 U.S.C. § 350a(c)(1)(B)] and is a prohibited act under section 301(s) of the Act [21 U.S.C. § 331(s)].
 
The above violations are not meant to be an all-inclusive list of violations for your products. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. 
 
Your firm should take prompt action to correct the violations addressed in this letter.  Failure to promptly correct these violations may result in regulatory action being initiated by FDA without further notice.  These actions include seizure or injunction.
 
We note that we have not conducted a complete review of your product labels and labeling. You may wish to provide complete product labeling as a part of any new infant formula notification. 
 
Within 15 working days after the date you receive this letter, you should notify this office, in writing, describing the corrective actions that you have taken to bring your firm into compliance. Please include copies of any documentation that demonstrates that the corrections have been made.  If you cannot complete corrective actions within 15 working days of receiving this letter, your response should state the reason for the delay and the time frame in which the corrective actions will be completed. 
 
Your written response should be sent to Kathleen M. Lewis, Team Leader, Labeling and Dietary Supplement Compliance Team (HFS-608), U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740. If you have any questions concerning this letter, please contact Ms. Lewis at 240-402-2148 or by e-mail at kathleen.lewis@fda.hhs.gov.
 
                                                                                   
Sincerely,
/S/
Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition
 
cc: FDA Cincinnati District Office