Santa Claus is the FDA’s Public Enemy #1, says Former FDA Regulatory Counsel

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Santa Claus should 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 has broken almost every rule in the book and violated numerous food, drug, facility registration and import laws, regulations and standards over the years as he has illegally imported 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 are cause for both alert and action, especially as the number of gift-hungry American children grows each year.

“I feel bad for the guy,” said England in a recent interview. “Nobody wants to poo-poo on his gift-giving and good cheer but he needs to realize that the FDA’s going to come after him at some point.” Mr. England cited three primary ways that Santa Claus’ activities would likely be targeted by FDA and its new risk-based screening system, PREDICT.

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 is in fact out of compliance, no matter how big or small the quantity. “They call that smuggling, folks,” England was heard saying.
Facility registration and inspection.  It’s a known fact that at the North Pole Santa employs thousands of workers and operates a series of factories and warehouses- many of which produce 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 must be properly registered with the FDA as well as have a U.S. Agent with whom FDA can correspond regarding the safety of the products and inspection of these facilities.  After a rigorous search of FDA’s data systems, it is apparent that at the current time none of Santa’s overseas manufacturing plants are registered with the FDA.

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 accompany the gifts and what kinds of claims, ingredients and instructions must be present.  Gifts received by 59 million American children (62,889,723 children – 5% naughty = 59,745,237) must all 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 this Christmas.  No one can be certain if all of the products that Santa delivers 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 reference to Santa Claus’s past history of successful importing.  “I know for a fact that there are no in-house attorneys working for Mr. Clause at the North Pole because lawyers hate the cold,” Mr. England stated.  When asked how Santa could become compliant again and get back 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.  “His heart is in the right place,” offered Mr. England, “I just hope that he will take the compliance side of things more seriously before the FDA really cracks down on him.”  Mr. England’s firm has extended an offer to help with Mr. Claus’s import compliance program before FDA puts Claus and his North Pole operation on FDA import alert, but has not received word back.

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