FDA WARNING_LETTER - Natures One Inc - August 31, 2012

The FDA issued a Warning Letter to Nature's One after reviewing product labeling and the website www.naturesone.com in August 2012. The letter states that Nature's One's 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 violate Section 412 of the Federal Food, Drug and Cosmetic Act (the Act).

The FDA concluded that these products are represented for use as infant formulas despite being labeled as "Toddler" formulas. Evidence cited includes statements on product labels indicating use for infants under one year when specified by a healthcare professional, presentation of nutrition information per 100 kilocalories consistent with infant formula requirements (21 CFR 107.10(a)), and website content. The website's "Suggested Age and Use" links list infants as suggested users and advise consulting healthcare professionals for infants under 12 months, providing a nutritional comparison chart against FDA infant formula requirements and competitor infant formulas. The FAQ section also includes similar statements.

These representations indicate an intent to market the products as infant formulas. Since Nature's One has not previously manufactured an infant formula, these are considered "new infant formulas" under Section 412(c)(2) of the Act. The firm failed to provide new infant formula notifications