WARNING LETTER

Prollergy Corporation/Ready Set Food MARCS-CMS 606913 — October 09, 2020

Delivery Method:: United Parcel Service
Product:: Food & Beverages

Recipient:: Recipient Name

Daniel J Zakowski; Prollergy Corporation/Ready Set Food; 15821 Ventura Blvd, Suite 450
Encino, CA 91436
United States

Issuing Office:: Center for Food Safety and Applied Nutrition (CFSAN); United States

WL 606913

WARNING LETTER

Dear Mr. Zakowski:

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed the label of your product, Ready Set Food brand introduction Stage 1, and your company website at the internet address www.readysetfood.com in January, March, and April 2020 where you take orders for the “Ready, Set, Food!” dietary supplement products. 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

The claims on your company website, where products can be purchased, establish that the Ready Set Food! brand products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce violates the Act.
Examples of some of the claims observed on your website that provide evidence that your products are intended for use as drugs include, but may not be limited to, the following:

Website, www.readysetfood.com:

•“Food allergies are on the rise, and all babies are at risk. . .Prevention is possible.”
• “Three clinical studies show that up to 80% of peanut, egg, and milk allergies can be prevented.”
• “[W]e developed Ready, Set, Food! for our children because we wanted to make food allergy prevention safe and easy. . .”
• “Food allergies are a growing problem across the world. I'm excited to partner with Ready, Set, Food! to start to reverse this growing epidemic. . .” (partial quote from Mark Cuban, firm investor)
• “Reduce the risk of your baby developing allergies by up to 80%. We recommend using Ready, Set, Food! for at least 6 months, or until your baby is regularly eating peanut, egg, and milk.”
• “Start Today And Protect Your Baby From Food Allergies”
• “A scientific breakthrough in childhood food allergy prevention”
• “[W]e now know that exposing babies to common allergenic foods early and often can significantly reduce their risk of developing food allergies.”
• “Continue for 6+ months. Sustain exposure to reduce the chance of developing a food allergy”
• “My son, Abe, had his first severe allergic reaction to peanut butter at the age of 7 months. Even though we knew about the recent studies supporting early and sustained introduction, starting at 7 months was simply too late for Abe. He had missed a critical immune window and now suffers from multiple food allergies. . .” (statement from Dr. Andrew Leitner, Co-Founder of Ready, Set, Foods)
• “Our evidence-based dosing uses the exact protein amounts studied in the landmark clinical trials on early and sustained allergen exposure, none of which documented any severe allergic reactions.”
• “This type of early and sustained food allergen introduction has been shown in landmark clinical trials to prevent up to 80% of common childhood food allergies.”
• “Many recent parents are wondering what is going on with this dramatic rise in food allergies in children. Our mission is to provide parents food allergy peace of mind with Ready, Set, Food!. . .”

• Testimonials:
o “I am so grateful to have a product that made it so easy to drastically reduce my child's risk of food allergies.”
o “I recommend Ready, Set, Food! for my patients because it's the easiest and safest way for parents to reduce their baby's risk of developing food allergies.”

• Blogs:
o “Ready, Set, Food! Helps Give 12,000 Families an Allergy-Free Future in Its First Two Years!”
o “Ready, Set, Food! advances its mission of protecting families from food allergies with their investment in and launch of preventallergies.org.”
o “Why Ready, Set, Food!? All babies are at risk for food allergies, but you can help prevent up to 80% of food allergies before they start.”
o “Mark Cuban Partners with Ready, Set, Food! to Reverse Food Allergy Epidemic . . .”
o “[I]ntroducing cow's milk products as a supplement can help prevent the most common food allergy”
o “Ready, Set, Food! offers the best defense against childhood food allergies.”
o “So, how does Ready, Set, Food! work to protect babies from food allergies?”
o “[I]ntroducing allergens before your baby turns 1 … lowers your baby’s risk of having a severe allergic reaction”

Twitter:
• “Ready, Set, Food! Reduce your baby’s risk of developing food allergies”
• “[E]ducating parents on the value of food allergy protection & Ready, Set, Food!”
• “[O]ur pitch to save over 200,000 babies per year from developing food allergies!”

Instagram:
• “Reduce your baby’s risk of developing food allergies”
• “Can’t wait to save as many babies as possible from food allergies” (Quote from Mark Cuban)
• “Ready, Set, Food! Reducing your baby’s risk of developing food allergies up to 80%”

LinkedIn:
• “Protect Your Baby From Food Allergies”
• “[W]e've developed an effective, evidence-based solution that makes it easy for parents to protect their babies from common food allergies like peanut, egg, and milk.”

Facebook:
• “Protect Your Baby From Food Allergies”
• “[O]ur pitch to save over 200,000 babies per year from developing food allergies…”
• “[I]mportance of early allergen introduction and how to protect your baby from these common food allergies to give your baby an allergy-free future!”
• “We Love Ready, Set, Food! … We’ve successfully introduced many allergy inducing foods to her with no issues whatsoever.” (customer comment)

Pinterest:
• “Ready, Set, Food! Protect your future foodie from food allergies”
• “Protect Your Baby. Help Prevent Peanut, Egg, and Milk Allergies”
• “Ready, Set, Food! Protect your little peanut from peanut allergies.”

Pediatrician Flyer:
• “HELP REDUCE THE RISK OF CHILDHOOD FOOD ALLERGIES …”

Patient Flyer:
• “EARLY AND SUSTAINED ALLERGEN INTRODUCTION REDUCES 67-80% OF PEANUT, EGG, AND MILK ALLERGIES”
• “Reduced risk of food allergies”
• “Reduce your baby’s risk of peanut, egg, milk allergies. . .early and sustained allergen introduction leads up to an 80% reduction in peanut, egg, and milk allergies.”

Preventing Food Allergies ebook entitled “A Parent’s Guide to Food Allergies” by Ready, Set, Food! (https://go.readysetfood.com/ebook-v1/mobile/index.html):
• “Making it Easy to Help Prevent 4 out of 5 Food Allergies. Ready, Set, Food!”
• “Our goal is to help parents protect their children from food allergies.”

Your Ready Set Food brand products are not generally recognized as safe and effective for the above referenced uses and, therefore, your Ready Set Food brand products are “new drugs” 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 submitted by a drug sponsor to demonstrate that the drug is safe and effective.

Misbranded Dietary Supplement

Even if your Ready Set Food brand Introduction Stage 1 product was not an unapproved new drug as noted above, our review of the product label and labeling reveal that it is a misbranded dietary supplement within the meaning of section 403 of the Act (21 U.S.C. §343) as noted below:

1. Your Ready Set Food brand Introduction Stage 1 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 unauthorized health claims. For example:
a. The product label bears the unauthorized health claim: “Exposing infants to allergenic foods early and often may reduce the risk of developing food allergies by up to 80%, according to recent landmark studies.”
b. The website labeling at www.readysetfood.com bears the claim “Our allergist-developed system gently introduces babies as young as four months old to peanut, egg, and milk, helping reduce their risk of developing these common food allergies by up to 80%.”
c. The Pediatrician Flyer, available at www.readysetfood.com, bears the claim “Early and sustained introduction reduces the risk of food allergies by 67-80%.”

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 infants “4+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 Ready Set Food brand Introduction Stage 1 product is misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] in that the outer package label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.

3. Your Ready Set Food brand Introduction Stage 1 product is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare a complete declaration of the net quantity of contents on the principal display panel as required by 21 CFR 101.7. For example, the product is comprised of unit containers held within a multiunit package; the outer package label bears the statement “15 packets” but fails to declare the net weight of each packet and the net weight of the entire package in accordance with 21 CFR 101.7(s) and 16 CFR 500.27(a) of the Fair Packaging and Labeling Act.

4. Your Ready Set Food brand Introduction Stage 1 product is misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. § 343(q)(5)(F)) in that the product does not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. For example:

a. The Supplement Facts label declares calories, sodium, total carbohydrate, and protein with amounts of zero or that can be declared as zero. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared in accordance with 21 CFR 101.36(b)(2)(i).
b. The Supplement Facts label bears incorrect % Daily Values for protein based on the Daily Protein Amounts information stated on the package insert. % Daily Value must be declared in accordance with 21 CFR 101.36(b)(2)(iii) and 21 CFR 101.9(c)(7).
c. The Supplement Facts label declares the serving size with an amount that is a range of values rather than the weight of each of the different packets. Serving Size must be declared in accordance with 21 CFR 101.36(b)(1) and 21 CFR 101.9(b)(7).
d. The Supplement Facts label lists sodium and potassium in the wrong order. Sodium and potassium, their quantitative amounts by weight per serving, and percent of the daily values should be listed after calcium in accordance with 21 CFR 101.36(b)(2)(i)(B).

5. Your Ready Set Food brand Introduction Stage 1 product is misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the inner packet labels do not include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).

The violations cited in this letter are not intended to be an all-inclusive list 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 all products marketed by your firm comply with the Act and its implementing regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, including, without limitation, seizure and/or injunction.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations noted above. Your response should include any documentation that would assist in evaluating your corrections. If you believe that your products are 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, please explain the reason for the delay and the date by which you will make 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.

Sincerely,
/s/
William A. Correll, Jr.
Director
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.