We are attaching a report prepared by Safety Behavior Analysis, Inc., a product safety consultant, that analyzed Megga Surprize™.  According to the report, an object’s physical characteristics (i.e., size, shape and consistency) determine where it is likely to go once inserted into the mouth.  The two-piece plastic egg in Megga Surprize™ is egg-shaped, smooth, and has “an effective maximum diameter” of 1.58 inches.  Although it has a narrow plastic ridge running longitudinally the length of the egg, this “slight ridge is unlikely to be effective in preventing the object from sliding from the mouth into the back of the throat” and obstructing a child’s airway.[1]  The report goes on to cite choking incidents involving objects of similar size and shape, noting that “widely distributed choking hazard data and technical reports indicate that spherical shapes smaller than 1.68 inches in diameter present a serious choking hazard.”  Although the label for Megga Surprize™ includes an inconspicuous statement that the product is “not suitable for children under 3 years old,” the report states that CPSC policy is to treat any product distributed with chocolate as intended for children of all ages.  In any event, based on past choking incidents, children over 3 are also at risk from a product of this size and shape.  The report concludes that the plastic egg in Megga Surprize™ constitutes a “serious choking hazard due to its size, shape, and intended age group.”    

            In short, because of the nature of this product, it is predictable that the plastic egg in Megga Surprize™ will find its way into the mouths of many small children, including children less than 3 years old.  Once in their mouths, the size and shape of the plastic egg indicate that it is likely to pose a serious choking hazard.  The plastic ridge running the length of the egg is not likely to prevent the plastic egg from moving to a dangerous position in the back of a child’s mouth.

            The Federal Food, Drug, and Cosmetic Act’s prohibition against nonnutritive objects “imbedded” in confectionery products has long served as an effective barrier against this type of combination toy/confectionery product.  At the time of the enactment of the law, Congress recognized the inherently dangerous nature of such products.

            We are surprised and disappointed that the FDA has reversed itself and issued a letter to the manufacturer stating that Megga Surprize™ is not adulterated under the FD&C Act.  Originally, the FDA had advised Whetstone that it must petition the agency for an authorizing regulation before marketing its product, and we find the FDA’s change in position very difficult to understand.  The FDA’s determination that the plastic egg in Megga Surprize™ is not “imbedded” in chocolate appears to be based on the highly technical fact that there is a “visible plastic rim running longitudinally around the plastic capsule, which cleanly and clearly separates the two hemispheres of chocolate.”  Section 402(d)(1) of the FD&C Act, however, provides that a confectionery product is adulterated if a nonnutritive object is “partially or completely imbedded” in it.  It seems obvious to us that the plastic egg in Megga Surprize™ is at least “partially” imbedded in chocolate.[2]  That plastic ridge is undoubtedly a clever device from a regulatory perspective, but we question whether it will protect children from choking.  The expert report discussed above concluded it may not.  Even if the FDA chose not to rely on § 402(d)(1), it should have, at a minimum, found this product adulterated by virtue of the fact that it contains a “deleterious substance which may render it injurious to health.”  21 U.S.C. § 342(a)(1). 

            From a procedural standpoint, we note that FDA made this decision without any public input and, as far as we know, without consulting with the CPSC.  The FDA had promised in 1997 to publish draft guidelines and a proposed rule on regulation of combination toy/confectionery products, but neither were issued.  The public and interested parties should have had the opportunity to comment before FDA gave the green light to proceed.  

By adopting a lax interpretation of § 402(d)(1) and apparently ignoring § 402(a)(1), we believe FDA is opening the door to a rash of imitative products.  Some of these knock-off products are likely to be even more dangerous than Megga Surprize™.  We are concerned that these products may cause choking injuries and possibly deaths in young children.

            We urge the CPSC to carefully analyze Megga Surprize™ and, if appropriate, take immediate enforcement action to protect small children.  We remind the CPSC that Easter is rapidly approaching, and an egg-shaped toy/confectionery product is likely to be an attractive addition to a child’s Easter basket.

Beyond our immediate concern about Megga Surprize™, we believe that this kind of combination toy/confectionery product poses unique safety problems.  These products represent an attractive nuisance, because they tempt children to engage in dangerous behaviors.  They encourage young children to put toys in their mouths, undermining parents’ advice not to do this.  Because the toys contained in these products are associated with candy and retain the smell of candy, they increase the risk of choking incidents.

NCL and CFA favor keeping these products out of the U.S. market entirely.  If they are to be allowed, however, the CPSC and the FDA must cooperate in developing regulations that will adequately protect small children.  Until such regulations are in place, products like Megga Surprize™ should not be marketed. 

Sincerely,

                                                            LINDA F. GOLODNER

President

                                                            National Consumers League

                                                            ARTHUR S. JAEGER

Assistant Director

                                                            Consumer Federation of America

Attachment       

cc:            Bernard A. Schwetz, Acting Principal Deputy Commissioner, FDA

Joseph Levitt, Director, Center for Food Safety and Applied Nutrition, FDA

Terry C. Troxell, Director, Office of Plant and Dairy Foods and Beverages, FDA

            Richard Blumenthal, Attorney General, State of Connecticut

            Bob Butterworth, Attorney General, State of Florida

Mike Hatch, Attorney General, State of Minnesota

Jennifer M. Granholm, Attorney General, State of Michigan

            J. Joseph Curran, Jr., Attorney General, State of Maryland

            Eliot Spitzer, Attorney General, State of New York

            Hon. Rosa DeLauro, U.S. House of Representatives

            Steve Berman, President, American Academy of Pediatrics