Faculty Fellow, New England Law | Boston; J.D., University of Virginia School of Law; B.A., Dartmouth College.
Perhaps you’ve read Rachel Handler’s investigation of the bucatini shortage of 2020. (Bucatini is essentially a thicker spaghetti-shaped pasta with a hole in the middle. Devotees swear by its sauce-absorbing capabilities.) Perhaps you also eagerly awaited its follow-up, Handler’s interview with the president of the De Cecco Pasta Company. You would have learned how an inspection by the U.S. Food and Drug Administration (FDA) found inadequate iron levels in De Cecco’s bucatini and resulted in the company’s destruction of large quantities of that product. Now the company says that it has remedied the issue, and awaits the release of the hold by the agency. This piece explores the legal basis for some of the agency actions described in Handler’s reports. It looks at how, and why, the FDA controls levels of iron and other nutrients in pasta, and how regulatory standards affect product labeling and food importation. It also discusses how the bucatini hold in 2020 was certainly not the first time an imported enriched pasta was the subject of an agency hold due to inadequate nutrient levels.
As Handler mentioned in her original article, bucatini and other pastas are governed by standards of identity. A standard of identity, as contained within FDA regulations, sets out the criteria that a product has to meet if it is sold under a certain name. For example, “eggnog” must contain not less than 6 percent milkfat; “blue cheese” must be at least 60 days old; and “mayonnaise” must contain not less than 65% vegetable oil by weight. Failure to conform to a relevant standard of identity where such a term is used is prohibited by the Federal Food, Drug, and Cosmetic Act (FD&C Act). Of note, the FDA has announced that it is currently working to modernize food standards of identity.
The relevant standard of identity for bucatini is that of an “enriched macaroni product,” which is described in 21 C.F.R. § 139.115. This is the legal provision that was cited in the FDA hold and referenced in Handler’s first article. The FDA claimed that the De Cecco bucatini failed to meet this standard of identity by lacking sufficient iron. Along with minimum and maximum iron levels (not less than 13 mg and not more than 16.5 mg in each pound), the enriched macaroni product standard of identity sets forth minimum and maximum amounts of certain B vitamins and for optional vitamin D and calcium. There are also certain size and shape requirements for enriched spaghetti, vermicelli, and macaroni (but none applicable to bucatini). “Enriched macaroni product,” thus, is the general category of enriched pastas; enriched macaroni, enriched spaghetti, and enriched vermicelli can be labeled under their own individual names, but other pasta types like bucatini do not have separate standards of identity and therefore are labeled as enriched macaroni products. There are also standards of identity in place for macaroni products (which are not enriched), enriched macaroni products with fortified protein, vegetable macaroni products, noodle products, enriched noodle products, and a variety of others.
The essential purpose of food enrichment is to promote public health by “improving the overall nutritional quality of the food supply.” The federal government makes food enrichment voluntary when a relevant enriched standard of identity is not used, but some states mandate that foods be enriched. However, although food enrichment is voluntary at the federal level, if a manufacturer labels a food with a standard of identity such as “enriched macaroni product,” then the product must conform with the relevant standard of identity’s description in order to comply with FDA regulations. An image of De Cecco bucatini box shows that the box is in fact labeled with the “enriched macaroni product” language and thus governed by the criteria set forth in the regulations for that standard of identity.
Foods imported into the United States must meet the same FDA requirements as do domestic foods. A source in Handler’s first article speculated that the FDA might have been prompted by a competitor’s tip to sample the De Cecco bucatini. De Cecco informed Handler that it did not know if this was the case (and was uninterested in finding out, as it was focused instead on its single goal of bringing its bucatini into compliance with U.S. standards).Whatever led the FDA to investigate the De Cecco bucatini in this instance, competitors and others can in fact easily report allegations to federal agencies. Trade-related violations, including health and safety allegations about imported products, can be reported to U.S. Customs and Border Protection through its online e-Allegations portal.
The FDA’s investigation into the De Cecco bucatini, however, was neither unique nor unprecedented. The FDA published import alerts in prior years, including as early as 2003 and including 2015, 2017, and 2019, for enriched macaroni products that failed to conform to the required iron levels for the relevant standard of identity. In some cases, the iron content was below that set by the standard of identity, but in other cases it was above the permitted maximum iron content. Other import alerts flagged products that failed to conform to the enriched macaroni products standard of identity’s threshold for riboflavin. These imports involved companies other than De Cecco, and involved enriched macaroni products imported from Mexico and Italy. Specific pasta types involved included fusilli, fettucine, spaghetti, penne ziti, macaroni, vermicelli, shells, and stars. So an impermissibly low iron (or other nutrient) level in pasta was not an issue limited solely to bucatini or to De Cecco, but has surfaced a number of times with respect to various types of pastas covered under the enriched macaroni standard of identity and different manufacturers.
 21 C.F.R. § 130.3(b).
 21 C.F.R. §§ 131.170, 133.106, and 169.140.
 21 U.S.C. § 342(b).
 FDA In Brief: FDA Reopens Comment Period Related to General Principles for Food Standards of Identity Modernization, U.S. Food & Drug Admin. (Feb. 20, 2020), https://www.fda.gov/news-events/fda-brief/fda-brief-fda-reopens-comment-period-related-general-principles-food-standards-identity.
 21 C.F.R. § 139.115(a)(1).Additional parameters apply to the maximum amount of defatted wheat germ that may optionally be used; additional substances, including dried yeast, enriched flour, and others, may be used as set forth by the regulations. 21 C.F.R. § 139.115(a)(2)-(5).
 21 C.F.R. § 139.115(b)-(d).
 21 C.F.R. § 139.115(e).
 21 C.F.R. Part 139.
 Guidance for Industry: Questions and Answers on FDA’s Fortification Policy, U.S. Food & Drug Admin. (Nov. 2015), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-fdas-fortification-policy.
 Questions and Answers on FDA’s Fortification Policy, U.S. Food & Drug Admin. (Nov. 2015), https://www.fda.gov/media/94563/download.See also, e.g.,ORS § 616.785 (Oregon statute making it unlawful for any person to manufacture, mix, compound, sell or offer for sale macaroni products unless they are enriched);
 21 C.F.R. § 101.3(a).
 Importing Food Products into the United States, U.S. Food & Drug Admin., https://www.fda.gov/food/food-imports-exports/importing-food-products-united-states.
 Import Alert 99-39, U.S. Food & Drug Admin., https://www.accessdata.fda.gov/CMS_IA/importalert_1144.html.