The U.S. Food and Drug Administration (FDA) has issued a warning letter to Prollergy Corporation, doing business as Ready Set Food, concerning their “Ready Set Food” brand introduction Stage 1 product. This letter, dated [Date of Original Letter – assumed January, March, and April 2020 based on text], outlines significant violations of the Federal Food, Drug, and Cosmetic Act. The FDA’s review of Ready Set Food’s product labeling and website, www.readysetfood.com, revealed that the company is marketing its dietary supplement with unapproved new drug claims and as a misbranded product. This article delves into the specifics of the FDA’s warning, highlighting the critical issues raised and what it means for consumers and the company.
FDA’s Unapproved New Drug Concerns Regarding Ready Set Food
The FDA’s primary concern revolves around claims made by Ready Set Food that position their products as drugs under section 201(g)(1)(B) of the Act. According to the FDA, the marketing language used by Ready Set Food on their website explicitly states or implies that their products are intended for use in the cure, mitigation, treatment, or prevention of disease. This classification as a drug triggers stringent regulatory requirements, including pre-market approval, which Ready Set Food has not obtained.
The warning letter meticulously lists examples of claims from the Ready Set Food website, www.readysetfood.com, that substantiate the FDA’s position. These claims are not subtle suggestions of health benefits; instead, they directly assert the product’s ability to prevent food allergies, a disease state. Here are some key examples cited by the FDA:
- “Food allergies are on the rise, and all babies are at risk. . .Prevention is possible.” This statement directly claims a preventative effect against a disease (food allergies).
- “Three clinical studies show that up to 80% of peanut, egg, and milk allergies can be prevented.” Quantifying prevention based on clinical studies further reinforces the drug claim.
- “[W]e developed Ready, Set, Food! for our children because we wanted to make food allergy prevention safe and easy. . .” The stated purpose of product development is explicitly for disease prevention.
- “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). Using terms like “reverse this growing epidemic” clearly aligns with disease treatment or mitigation.
- “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.” Direct risk reduction claims linked to product usage duration are characteristic of drug claims.
- “Start Today And Protect Your Baby From Food Allergies” and “Protect Your Baby From Food Allergies”. These are direct and unequivocal prevention claims.
- “A scientific breakthrough in childhood food allergy prevention”. Positioning the product as a “breakthrough” in prevention elevates it beyond a mere food or supplement.
- “[W]e now know that exposing babies to common allergenic foods early and often can significantly reduce their risk of developing food allergies.” While early allergen introduction is a recognized strategy, framing it as a product benefit to “reduce risk” in marketing contexts can lead to drug claims.
- “Continue for 6+ months. Sustain exposure to reduce the chance of developing a food allergy”. Emphasizing sustained use for risk reduction is another drug-claim indicator.
- Testimonials: Statements like “I am so grateful to have a product that made it so easy to drastically reduce my child’s risk of food allergies” and “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” further amplify the perception of the product as a disease preventative.
These claims, pervasive across the Ready Set Food website and marketing materials including blogs, social media (Twitter, Instagram, LinkedIn, Facebook, Pinterest), and promotional flyers (Pediatrician Flyer, Patient Flyer), led the FDA to conclude that Ready Set Food products are “new drugs” under section 201(p) of the Act. New drugs require FDA approval before they can be legally introduced into interstate commerce, a requirement Ready Set Food has not met. The FDA approval process mandates scientific data demonstrating the drug’s safety and effectiveness for its intended uses. Without this approval, Ready Set Food is in violation of sections 301(d) and 505(a) of the Act.
FDA’s Misbranded Dietary Supplement Concerns for Ready Set Food
Even if Ready Set Food’s Introduction Stage 1 product were not classified as an unapproved new drug, the FDA identified several ways in which it is misbranded as a dietary supplement under section 403 of the Act. These misbranding issues range from unauthorized health claims to labeling deficiencies.
Unauthorized Health Claims
The FDA pinpointed unauthorized health claims on the Ready Set Food product label and labeling, violating section 403(r)(1)(B) of the Act. Health claims, which characterize the relationship between a substance and a disease or health-related condition, are strictly regulated. They must be pre-authorized by the FDA through regulations or the health claim notification provision, neither of which applies to Ready Set Food’s claims.
Specific examples of unauthorized health claims include:
- Product Label: “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.”
- Website Labeling: “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%.”
- Pediatrician Flyer: “Early and sustained introduction reduces the risk of food allergies by 67-80%.”
Furthermore, FDA regulations (21 CFR 101.14(e)(5)) generally prohibit health claims on products intended for infants and toddlers under two years of age unless specifically provided for in a regulation. Ready Set Food’s product is labeled for infants “4+ months,” placing it within this restricted category.
The FDA also addressed Ready Set Food’s claims in relation to a Letter of Enforcement Discretion issued by the FDA in 2017 concerning qualified health claims for ground peanuts and reduced risk of peanut allergy. This letter was very specific, applying only to ground peanuts, for infants with severe eczema and/or egg allergy, and for reducing the risk of peanut allergy, not food allergies in general. Ready Set Food’s claims are broader, targeting general food allergy risk reduction for a wider infant population, and thus do not fall under the enforcement discretion outlined in the FDA’s letter.
Labeling Deficiencies
Beyond health claims, the FDA identified several labeling deficiencies that constitute misbranding under section 403 of the Act.
- Missing Manufacturer Information (Section 403(e)(1)): The outer package label fails to include the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5. This basic information is crucial for consumer transparency and traceability.
- Incomplete Net Quantity Declaration (Section 403(e)(2)): The label lacks a complete declaration of the net quantity of contents on the principal display panel, violating 21 CFR 101.7 and the Fair Packaging and Labeling Act. While the outer package states “15 packets,” it omits the net weight of each packet and the total net weight of the package, essential for consumers to understand the amount of product they are purchasing.
- Incorrect Nutrition Information (Section 403(q)(5)(F)): The product fails to present nutrition information on the labeling as mandated by 21 CFR 101.36 and 21 CFR 101.9. Specific issues include:
- Declaration of nutrients (calories, sodium, etc.) with zero values, which should not be declared if they are not present in significant amounts (21 CFR 101.36(b)(2)(i)).
- Incorrect % Daily Values for protein, contradicting information on the package insert (21 CFR 101.36(b)(2)(iii) and 21 CFR 101.9(c)(7)).
- Serving size declared as a range instead of a specific weight for each packet (21 CFR 101.36(b)(1) and 21 CFR 101.9(b)(7)).
- Incorrect order of sodium and potassium in the Supplement Facts label (21 CFR 101.36(b)(2)(i)(B)).
- Missing “Dietary Supplement” Statement on Inner Packets (Section 403(s)(2)(B)): The inner packet labels do not include the statement of identity “dietary supplement,” as required by 21 CFR 101.3(g). This omission can cause confusion about the product’s nature.
Implications and Required Actions for Ready Set Food
The FDA warning letter is a serious matter, indicating significant regulatory non-compliance. The violations outlined, both concerning unapproved new drug claims and misbranding as a dietary supplement, carry potential consequences for Ready Set Food. Failure to promptly and adequately address these issues could lead to enforcement actions, including product seizure and/or injunction, which could severely disrupt the company’s operations.
The FDA has directed Ready Set Food to take immediate corrective action and, within fifteen working days of receiving the letter, to provide a written response detailing the specific steps taken to rectify the violations. This response must include supporting documentation of the corrections. If Ready Set Food believes their products are not in violation, they must provide their reasoning and supporting information for the FDA’s consideration. Should corrective action take longer than fifteen working days, Ready Set Food must explain the delay and provide a timeline for completion.
This warning letter underscores the FDA’s rigorous oversight of health claims and labeling for food and dietary supplement products, especially those targeting vulnerable populations like infants. Companies like Ready Set Food must ensure their marketing and labeling practices fully comply with FDA regulations to avoid regulatory repercussions and to maintain consumer trust. For consumers, this situation highlights the importance of understanding that claims of disease prevention or treatment by food products or supplements should be critically evaluated, and that FDA approval is necessary for such health-related claims to be made legally. The case of Ready Set Food serves as a reminder of the stringent regulatory landscape governing health-related claims in the food and supplement industry and the FDA’s commitment to protecting public health.
