Santa Claus Would be the FDA’s Public Enemy #1 if He Were Real, Says Former FDA Regulatory Counsel

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If Santa Claus were a real person then he would have broken almost every importing rule in the book and violated countless FDA regulations, according to former FDA Regulatory Counsel, Benjamin England.

[Santa] would need to take the compliance side of things more seriously before the FDA cracked down on him.... -Benjamin England

If Santa were real he would be at the top of the U.S. Food And Drug Administration’s “naughty list” according to Benjamin England, a 17-year veteran of the FDA and Founder of According to England Santa Claus would have broken almost every rule in the book and violated numerous food, drug, facility registration and import laws, regulations and standards over the years if he were real. He would be guilty of illegally importing millions of dollars worth of merchandise to children in the United States, albeit as gifts. Since all imports coming into the United States must comply with United States Customs regulations, Santa’s activities every December 24th would be cause for both alert and action, especially as the number of gift-hungry American children grows each year.

Mr. England cited three primary ways that Santa Claus’s activities would likely be targeted by FDA and its new risk-based screening system, PREDICT.

1.    Undeclared food, drug and cosmetic imports. Many children request edible gifts for Christmas such as chocolate or candy- others request cosmetic products including make-up kits or lip-gloss. By bringing these products into the United States and failing to have them undergo proper FDA screening and inspection, Santa would be out of compliance, no matter how big or small the quantity. “They call that smuggling, folks,” England was heard saying.

2.    Facility registration and inspection. Santa employs thousands of workers and operates a series of factories and warehouses at the North Pole, according to the traditional Santa Claus story. These factories would be producing food products, beverages, medical devices (such as kids sunglasses), and pet chews, or involve hazardous chemicals in production (such as with plastics). According to Benjamin England these facilities would have to be properly registered with the FDA as well as have a U.S. Agent with whom FDA could correspond regarding the safety of the products and inspection of these facilities.

3.    Labels and packaging. With 2.2 billion children in the world receiving at least 1 gift per Christmas, one can imagine how many packages and labels would accompany Santas gifts and what kinds of claims, ingredients and instructions would be present. Gifts received by 59 million American children (62,889,723 children – 5% estimated naughty = 59,745,237) would all have to have compliant labels and packaging, says Mr. England, especially the claims and statements on products like candy, cosmetics or medical devices which minors might be receiving. No one could be certain if all of the products that Santa delivered would have labels and packaging that are compliant with current U.S. FDA regulations and the Food Safety Modernization Act. Recent cases include the popular “Live Forever Juice” product that guarantees its drinkers total immortality and violates countless FDA labeling requirements.

“Just because you’ve been doing something a long time without having any FDA detentions or refusals before doesn’t mean you’re doing it right,” said Mr. England. “In the Santa Claus story I know for a fact that there would be no in-house attorneys working for Mr. Clause at the North Pole because lawyers hate the cold,” Mr. England stated. When asked how a real-life Santa could successfully import products and stay on the FDA’s “nice list” Mr. England explained that a partnership with a competent FDA consulting firm could do wonders, especially in regard to the facility registrations and labeling compliance. “I know his heart would be in the right place,” offered Mr. England, “But he would need to take the compliance side of things more seriously before the FDA cracked down on him.” Mr. England stated that if Santa were real and needed help with his import compliance program that his firm would be more than willing to come to his aid.

Sources: is an FDA consulting firm helping U.S. and foreign companies navigate through and meet complex FDA regulations for marketing and importing foods, dietary supplements, drugs, cosmetics and medical devices. Benjamin L. England, Founder and CEO, is a former 17-year veteran of the FDA and served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs. Contact us at, call (410) 740-3403 or contact Jon Barnes at jrbarnes (at)


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