- Delivery Method:
- United Parcel Service
Food & Beverages
Recipient NameGregory Shewchuk
Recipient TitleChief Executive Officer
- Before Brands Inc
1160 Chestnut St
Menlo Park, CA 94025-4312
- Issuing Office:
- Center for Food Safety and Applied Nutrition (CFSAN)
Dear Mr. Shewchuk:
The United States Food and Drug Administration (FDA) has reviewed the label of your product, Spoonfulone brand Puffs, Strawberry flavor, and has reviewed your website at www.spoonfulone.com in May, June, and August 2020. Based on our review, we have found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act). You may find links to the Act and applicable regulations on our website, www.fda.gov.
Unapproved New Drugs
Claims in your product label, product insert, and website, www.spoonfulone.com, from which product may be ordered, establish that the Spoonfulone brand Puffs, Strawberry flavor, product is a drug under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act.
Examples of some of the claims that provide evidence that this product is intended for use as a drug include:
• “Help protect your child from developing a food allergy”
• “Spoonfulone. The most complete food allergy protection system”
• “SpoonfulOne helps protect children from developing a food allergy and is a complete mix … of all the food groups associated with over 90% of food allergies.”
•“PROACTIVE PROTECTION STARTS NOW. . . How does the continued use of SpoonfulOne help protect my baby from developing a food allergy?”
• “What if you could help stop a food allergy before it starts? Spoonful One makes it possible. Feeding SpoonfulOne daily, from infancy through early childhood helps protect your baby from developing a food allergy.”
• “In an independently administered nationwide survey of more than 300 U.S. pediatricians, 72% recommend SpoonfulOne as a product to help protect children from developing a food allergy.”
• On webpage entitled “Press & News” “Allergy prevention: The fascinating method parents are turning to.”
o “There’s new advice to prevent food allergies in children.”
o “An end to food allergy?”
• On webpage entitled “Research”:
o “Here are a few facts about food allergies. Early dietary exposure reduced food allergy risk by 81% compared to avoidance”
o “The most complete food allergy protection system*”
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under section 201(p) of the Act, 21 U.S.C. § 321(p). New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act, 21 U.S.C. § 331(d) and 355(a). FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
Even if your Spoonfulone brand Puffs, Strawberry flavor, was not an unapproved and misbranded new drug, it would still be misbranded within the meaning of section 403 of the Act (21 U.S.C. § 343) as noted below:
1.Your Spoonfulone brand Puffs, Strawberry flavor, product is misbranded within the meaning of section 403(r)(1)(B) of the Act [21 U.S.C. § 343(r)(1)(B)] because the label and labeling include the following unauthorized health claims:
• On the product label: “An independently administered nationwide survey of more than 200 U.S. Pediatricians, 74% supported SpoonfulOne to reduce the risk of developing a food allergy and to consistently expose a child to a diversity of potential food allergens beforethe child becomes allergic.”
• On your website at www.spoonfulone.com: “In an independently administered nationwide survey of more than 300 U.S. pediatricians, 72% recommend SpoonfulOne as a product to help protect children from developing a food allergy.”
• The research page on your website at www.spoonfulone.com: “Landmark studies, global research and guidelines now say early and regular dietary exposure to potential food allergens can help reduce the risk of a child developing a food allergy.”
These health claims misbrand your product because they have not been authorized either by regulation [see section 343(r)(3)(A)-(B) of the Act [21 U.S.C. § 343(r)(3)(A)(B)]] or under authority of the health claim notification provision of the Act [see section 343(r)(3)(C) of the Act [21 U.S.C. § 343(r)(3)(C)]]. Furthermore, in accordance with 21 CFR 101.14(e)(5) health claims are not permitted on products that are represented for infants and toddlers less than 2 years of age unless the claim is specifically provided for in a regulation. According to the label, this product is intended for “Crawler-6+months.”
We also note that FDA has not issued a Letter of Enforcement Discretion for such claims. To the extent these claims pertain to the ingestion of peanuts, they are not consistent with the claim in the Letter of Enforcement Discretion1 FDA issued in response to a petition for a qualified health claim for ground peanuts and reduced risk of developing peanut allergy. The qualified health claim for which FDA stated its intent to exercise enforcement discretion is limited to the use of ground peanuts in infants to reduce the risk of developing peanut allergy and is further limited to infants with severe eczema and/or egg allergy. The claims on the label and labeling of your product are not specifically for reducing the risk of developing peanut allergy but are for reducing the risk of developing food allergies in general. Furthermore, the claims are directed at infants in the general population rather than infants with severe eczema and/or egg allergy.
2. Your Spoonfulone brand Puffs, Strawberry flavor, product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the label does not bear the common or usual name of each ingredient. The ingredient statement bears the collective term “foundational food blend.” “Foundational food blend” is not a collective term provided by 21 CFR 101.4(b). Each ingredient in the “foundational food blend” must be declared by its common or usual name in descending order of predominance by weight.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
You should take prompt action to correct the violation in this letter, as well as any other violations associated with your product or other products marketed by your firm. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Sections 302 and 304 of the Act provide for seizure of violative products and injunction against the manufacturers and distributors of violative products [21 U.S.C. §§ 332 and 334].
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration. 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 written reply should be directed to Ms. Tyra Wisecup, Compliance Officer, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions, you may also contact Ms. Wisecup at Tyra.Wisecup@fda.hhs.gov.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety and Applied Nutrition
1 In 2017, after conducting a systematic review of the available scientific evidence, the FDA determined that it intended to exercise enforcement discretion for the use of a qualified health claim for infants with severe eczema and/or egg allergy characterizing the relationship between the consumption of foods containing ground peanuts beginning between 4 and 10 months of age and a reduced risk of developing peanut allergy by 5 years of age.
The Letter of Enforcement Discretion was issued and announced in a Constituent Update on September 7, 2017, https://www.fda.gov/food/cfsan-constituent-updates/fda-acknowledges-qualified-health-claim-linking-early-peanut-introduction-and-reduced-risk. The claim for which FDA stated its intent to exercise enforcement discretion reads:
For most infants with severe eczema and/or egg allergy who are already eating solid foods, introducing foods containing ground peanuts between 4 and 10 months of age and continuing consumption may reduce the risk of developing peanut allergy by 5 years of age. FDA has determined, however, that the evidence supporting this claim is limited to one study.
If your infant has severe eczema and/or egg allergy, check with your infant’s healthcare provider before feeding foods containing ground peanuts.
The Letter of Enforcement Discretion was in response to a petition from Assured Bites, Inc., for a qualified health claim linking early introduction of peanuts to reduced risk of developing peanut allergy. Qualified health claims are not the same as “authorized health claims,” which must be supported by significant scientific agreement among experts in the field. Qualified health claims are supported by credible scientific evidence, but do not meet the more rigorous “significant scientific agreement” standard required for an authorized health claim. As such, they are accompanied by qualifying language or a disclaimer so that the level of scientific evidence supporting the claim is accurately communicated. The FDA’s intent to exercise enforcement discretion for the use of the qualified health claim means that the agency does not intend to object to its use as long as the claim, the products and their labels and labeling are consistent with all of the factors FDA has stated in the Letter of Enforcement Discretion.