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`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MARYLAND
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`NATURAL PRODUCTS ASSOCIATION,
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`Plaintiff,
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`FOOD AND DRUG ADMINISTRATION;
`DEPARTMENT OF HEALTH AND HUMAN
`SERVICES; XAVIER BECERRA, in his official
`capacity as Secretary of the Department of
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`Health and Human Services; and
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`JANET WOODCOCK, M.D., in her official
`capacity as Acting Commissioner of Food
`and Drugs,
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`Defendants.
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`Civil Action No. ______
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`COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF
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`Plaintiff, Natural Products Association (“NPA”), for its complaint against the defendants,
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`Food and Drug Administration (“FDA”), Department of Health And Human Services (“HHS”),
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`Xavier Becerra, in his official capacity as Secretary of the Department of Health And Human
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`Services, and Janet Woodcock, M.D., in her official capacity as Acting Commissioner of the FDA
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`(collectively referred to as “Defendants”), alleges as follows.
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`INTRODUCTION
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`NPA brings this action against Defendants for declaratory and injunctive relief.
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`1.
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`Defendants have concluded that a product called N-acetyl-L-cysteine (“NAC”) is excluded from
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`the definition of a dietary supplement under a provision of the Food, Drug, and Cosmetic Act, as
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`amended by the Dietary Supplement Health and Education Act, 21 U.S.C. § 321(ff)(3)(B)(i).
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`Defendants have taken final agency action in their determination that the provision at issue applies
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`Case 8:21-cv-03112-GLS Document 1 Filed 12/06/21 Page 2 of 21
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`retroactively as a matter of law. There is, however, nothing in the relevant statute that allows for
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`retroactive application.
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`2.
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`NPA respectfully requests that the Court enter a declaratory judgment and a
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`preliminary and permanent injunction under the Administrative Procedure Act and hold unlawful
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`and set aside FDA’s final actions that are arbitrary, capricious, an abuse of discretion, and contrary
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`to law. More particularly, NPA requests that this Court order that FDA cease its unlawful
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`retroactive application of the Food, Drug, and Cosmetic Act, as amended by the Dietary
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`Supplement Health and Education Act.
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`PARTIES
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`3.
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`Natural Products Association is a Delaware non-profit corporation that does
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`business as Natural Products Association. It has a principal place of business in Washington, DC.
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`4.
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`FDA is an agency of the United States government responsible for administering,
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`among other things, the Food, Drug and Cosmetics Act, as amended.
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`5.
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`HHS is an executive department of the United States government and is responsible
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`for the FDA.
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`6.
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`Secretary Becerra is the Secretary of HHS. He oversees, among other things, the
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`FDA. He is sued in his official capacity.
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`7.
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`Dr. Woodcock is the Acting Commissioner of Food and Drugs. She oversees the
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`activities of FDA. She is sued in her official capacity.
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`JURISDICTION
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`8.
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`This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C. §§
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`1331, 1346, and 5 U.S.C. §§ 701-06. An actual controversy exists between the parties within the
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`meaning of 28 U.S.C. § 2201(a) and this Court may grant declaratory relief, injunctive relief, and
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`other relief pursuant to 28 U.S.C. §§ 2201-02 and 5 U.S.C. §§ 705-06.
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`9.
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`Personal jurisdiction over Defendants exists in the State of Maryland because they
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`are engaged in substantial activity here and the FDA is headquartered in the state.
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`10.
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`Venue in this District is proper under 28 U.S.C. § 1391(e) because the action seeks
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`relief against federal agencies located in this district and a substantial part of the events or
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`omissions giving rise to the claim occurred in this district.
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`FACTS
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`I.
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`NPA/STANDING
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`11.
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`Founded in 1936, NPA is the nation’s largest and oldest nonprofit organization
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`dedicated to the natural products industry. Natural products are represented by a wide array of
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`consumer goods that grow in popularity each year. These products include natural and organic
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`foods, dietary supplements, pet foods, health and beauty products, “green” cleaning supplies and
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`more.
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`12.
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`NPA advocates for the rights of consumers to have access to safe products that will
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`maintain and improve their health, and for the rights of retailers and suppliers to sell these products.
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`NPA represents over 700 member organizations, accounting for more than 10,000 retail,
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`manufacturing, wholesale, and distribution locations of natural products, including foods, dietary
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`supplements, and health/beauty aids. NPA unites a diverse membership, from the smallest health
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`food store to the largest dietary supplement manufacturer.
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`13.
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`NPA has standing to bring this action on behalf of itself and its members.
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`14.
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`NPA advocates before Congress, FDA, the Federal Trade Commission, and other
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`federal and state agencies, legislatures, state attorneys’ general and courts. Additional information
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`about NPA and its work is available at https://www.npanational.org/.
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`15.
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`Further, NPA has taken a leadership role in promoting quality standards and has
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`developed proactive certification programs for that purpose. NPA was the first organization to
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`offer a third-party good manufacturing practices (“GMP”) certification program for the
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`manufacturing of dietary supplements and dietary ingredients. NPA’s GMP standard includes all
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`of the FDA GMP requirements of 21 C.F.R. Part 111 as well as certain requirements that exceed
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`Part 111 or reflect best industry practices. NPA’s GMP certification is only awarded to companies
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`that meet a high level of compliance with NPA’s standard. NPA’s certification not only meets, but
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`exceeds, FDA’s GMP requirements. NPA’s certification is awarded only after companies’
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`satisfaction of NPA’s rigorous requirements have been verified through comprehensive third-party
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`inspections of the company’s facilities and GMP-related documentation.1 Any company that
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`receives NPA’s GMP certification should be considered to be in compliance with all FDA GMP-
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`related standards. NPA also has “Natural Seal” Standard and Certification programs that dictate
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`whether cosmetic, personal-care-products, and certain home care products can be deemed truly
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`“natural.”2
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`16.
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`In addition, NPA’s “TruLabel” program is a dietary supplement label registration
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`and random-testing program adopted by NPA in 1990 and subsequently made a requirement for
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`supplier membership in 1995. This internal oversight program has created a high level of
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`confidence with retailers and consumers that products sold in the marketplace under NPA’s
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`1 See https://www.npanational.org/certifications/npa-gmp-certification-program/.
`2 See https://www.npanational.org/certifications/natural-seal/.
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`TruLabel program are accurately labeled; establish an ongoing self-regulatory process within the
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`industry; demonstrate industry maturity to legislators; and provide a comprehensive industry
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`product database. Under the TruLabel program, products are periodically selected for laboratory
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`analysis to confirm the label; in other words, to verify that what is on the label is what is in the
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`product.3
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`17.
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`Another example of industry self-regulation effectuated by NPA’s oversight is the
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`Supplement Safety and Compliance Initiative (“SSCI”). SSCI is an industry-driven initiative led
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`by the nation’s leading retailers to provide a harmonized benchmark to recognize various safety
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`standards throughout the entire dietary supplement supply chain. SSCI provides enhanced quality
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`assurance for products on retailer shelves. Dietary supplements must meet or exceed the SSCI
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`benchmark to be accepted in participating major retailers, all with the goal of providing quality
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`products and increasing consumer confidence that the products they are consuming are safe.4
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`18.
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`NPA also organized the Natural Products Foundation, a 501(c)(3) entity, to
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`stimulate and support research, education and knowledge regarding dietary supplements,
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`nutritional foods, and related products, with the overall objective of advancing the knowledge of
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`the public, and thereby, improving the public health.
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`19.
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`NPA played a key role in the passage of the Dietary Supplement Health and
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`Education Act of 1994 (“DSHEA”), Pub. L. No. 103-417, 108 Stat. 4325. This important
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`legislation, discussed further below, struck a balance between the need for consumers to have
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`access to and information about safe and effective dietary supplements while also preserving the
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`3 See https://www.npanational.org/certifications/trulabel-program/.
`4 See http://www.ssciglobal.org/.
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`government’s interest in protecting the public from unsafe products and false and misleading
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`claims.
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`20.
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`The dietary supplement industry is large. It includes domestic sales likely
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`exceeding $50 billion annually has grown dramatically. In the United States, the market currently
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`exceeds $35 billion and includes thousands of companies – including manufacturers, retailers, and
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`formulators that create and distribute a vast array of products aimed at improving consumer health.
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`While estimates vary, the now former Commissioner of the FDA stated that: “What was once a $4
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`billion industry comprised of about 4,000 unique products, is now an industry worth more than
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`$40 billion, with more than 50,000 – and possibly as many as 80,000 or even more – different
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`products available to consumers.”5 “The use of dietary supplements, including vitamins, minerals,
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`amino acids, or herbs, has become a routine part of the American lifestyle. Three out of every four
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`American consumers take a dietary supplement on a regular basis. For older Americans, the rate
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`rises to four in five. And one in three children take supplements, either given to them by their
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`parents or, commonly in teens, taking them on their own.”6 Indeed, physicians frequently
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`recommend a supplement regimen in addition to medical intervention.
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`21.
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`As the natural product industry has grown, increased internal oversight, innovated,
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`and become more sophisticated in increased compliance and internal oversight as well as
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`innovation of new products and methods of use, consistent and applicable legal and regulatory
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`enforcement has been lacking. In some instances, FDA has taken illogical actions to preclude
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`products from the market without justification on the one hand, or simply refused to enforce its
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`5 Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new efforts to
`strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight (Feb.
`11, 2019), available at https://www.fda.gov/news-events/press-announcements/statement-fda-
`commissioner-scott-gottlieb-md-agencys-new-efforts-strengthen-regulation-dietary.
`6 Id.
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`own statutes and regulations on the other hand. For example, under the Food, Drug, and Cosmetic
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`Act, FDA is required to review a distributor’s basis for concluding that a “new dietary ingredient”
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`(“NDI”) is reasonably expected to be safe prior to that distributor putting that NDI into commerce.
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`Although it has been conservatively estimated that there have been tens of thousands of new
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`dietary ingredients introduced into the market since DSHEA, FDA has reviewed the basis for
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`safety of less than 900 unique ingredients. FDA’s enforcement of its enabling statutes and
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`promulgated regulations has been slipshod at best, despite organizations like NPA striving to
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`advocate for and provide oversight and compliance programs for safe dietary ingredients and
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`products for consumers.
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`22. With specific reference to NAC, the actions by FDA impairs NPA’s ability to carry
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`out its mission and commitment to consumer safety and access to natural health ingredients. NPA
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`and its members have spent significant time and money to respond to FDA’s new position,
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`discussed below, that the exclusion provision of DSHEA known as the “drug preclusion” or “race
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`to market clause” is to be given retroactive effect and that, as such, now suddenly bars NAC from
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`the supplement market. Were FDA properly interpreting and applying DSHEA, NPA would not
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`have been forced to take action in response, including: discussions and written communications
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`with regulators and third parties, preparation and submission of a Citizen Petition, submission of
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`Freedom of Information Act requests, responses to media inquiries and the preparation and filing
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`of this action. NPA’s members have suffered harm as a direct and proximate result of FDA’s recent
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`final agency actions concluding that the drug exclusion provision of DSHEA applies retroactively
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`to NAC. NPA members who have been selling NAC for years, if not decades, have seen their sales
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`dry up as result of having to preemptively pull products from the shelves by virtue of FDA’s
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`unlawful decisions.
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`23.
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`As discussed further below, in 2020, Amazon.com implemented its take-down
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`policy requiring sellers on their platform to remove NAC-containing products that would violate
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`FDA’s recent final agency actions determining that the ingredient could not be used in products
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`marketed as dietary supplements. In many instances, companies that are NPA members were
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`forced to proactively remove their products from Amazon to avoid harm to their brands, which
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`was a direct result of FDA’s final agency decisions and statements aimed at removing NAC from
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`the supplement market. NPA’s members have lost and will continue to lose significant revenue
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`because Amazon, among other online retailers, will no longer allow companies to sell NAC.
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`24.
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`Further, FDA has recently denied export certificates sought by NPA members for
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`products that contain NAC. By denying export certificates, FDA has taken another final agency
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`action that works to preclude U.S. distributors from selling NAC-containing products in overseas
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`markets due to its misplaced position on DSHEA’s drug exclusion provision.
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`II.
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`REGULATION OF DIETARY SUPPLEMENTS
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`25.
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`Asserting that “improving the health status of United States citizens ranks at the top
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`of the national priorities of the Federal Government” and that “the importance of nutrition and the
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`benefits of dietary supplements to health promotion and disease prevention have been documented
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`increasingly in scientific studies,” DSHEA became law on October 25, 1994 as an amendment to
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`the Food, Drug, and Cosmetic Act. DSHEA represented a victory for the millions of consumers of
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`dietary supplements who felt that FDA advocated unreasonable regulatory guidelines prior to the
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`passage of DSHEA. The language of DSHEA addressed the aforementioned consumer concern by
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`stating that “the Federal Government should not take any actions to impose unreasonable
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`regulatory barriers limiting or slowing the flow of safe products and accurate information to
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`consumers” and that “dietary supplements are safe within a broad range of intake, and safety
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`problems with the supplements are relatively rare.” DSHEA § 2. DSHEA further established that
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`“consumers should be empowered to make choices about preventive health care programs based
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`on data from scientific studies of health benefits related to particular dietary supplements.” Id. §
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`2(8).
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`26.
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`DSHEA was
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`introduced
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`to counteract “unnecessarily stringent” federal
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`intervention into the manufacturing, sale, labelling of dietary supplements and government
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`overregulation. 103 CONG. REC. S4577 (daily ed. Apr. 7, 1993) (statement of Sen. Hatch); 103
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`CONG. REC. S17049 (daily ed. Nov. 23, 1993) (statement of Sen. Hatch). The legislation
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`concluded that consumer well-being is improved when there is greater access to dietary
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`supplements. 103 CONG. REC. S4577 (daily ed. Apr. 7, 1993) (statement of Sen. Hatch).
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`Supplement producers and related companies should be free from intervention as long as “the
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`labelling and advertising are truthful, non-misleading, and there exists a reasonable scientific basis
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`for products claims.” Id.
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`27.
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`Section 201(ff) of the Food, Drug, and Cosmetic Act, as amended by DSHEA,
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`specifically defined what it means to be a “dietary supplement.” In relevant part, the term is defined
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`as:
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` a product (other than tobacco) intended to supplement the diet that bears or
`contains one or more of the following ingredients:
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`(A) a vitamin;
`(B) a mineral;
`(C) an herb or other botanical;
`(D) an amino acid;
`(E) a dietary substance for use by man to supplement the diet by increasing
`the total dietary intake; or
`(F) a concentrate, metabolite, constituent, extract, or combination of any
`ingredient described in clause (A), (B), (C), (D), or (E).
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`21 U.S.C. § 321(ff)(1). Section 201(ff)(3)(B) of DSHEA goes on to exclude from the definition of
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`dietary supplement:
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`(i) an article that is approved as a new drug under section 505, certified as an
`antibiotic under section 507, or licensed as a biologic under section 351 of the
`Public Health Service Act (42 U.S.C. 262), or
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`(ii) an article authorized for investigation as a new drug, antibiotic, or biological
`for which substantial clinical investigations have been instituted and for which the
`existence of such investigations has been made public,
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`which was not before such approval, certification, licensing, or authorization
`marketed as a dietary supplement or as a food unless the Secretary, in the
`Secretary’s discretion, has issued a regulation, after notice and comment, finding
`that the article would be lawful under this Act.
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`21 U.S.C. § 321(ff)(3)(B). The first exception, the one most relevant to this case, means that
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`companies may not market in products labeled as dietary supplements an article that has been
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`approved as a new drug unless the article was marketed as a dietary supplement or as a food before
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`it obtained approval as a drug. Significantly, DSHEA did not include any provision indicating that
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`any of its regulations, including the drug exclusion provision was intended to operate retroactively.
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`28.
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`Particularly, the legislative history of DSHEA actually contradicts any notion that
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`the drug provision has retroactive effect:
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`On occasion, a substance that is properly included as a dietary ingredient in a
`dietary supplement (food) product may also function as an active ingredient in a
`drug product. There is nothing particularly surprising about this fact.
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`As an example, the dietary substance L-carnitine may properly be used as an
`ingredient in a dietary supplement (as FDA itself has acknowledged), although it is
`also the active ingredient in a drug product that has been approved by FDA for a
`particular prescription-only usage. Similarly, the substance caffeine is a natural
`component offered in products such as coffee and tea; it is used as an added
`ingredient in foods, including carbonated beverages, and it has also been approved
`by FDA as a drug.
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`Sen. Rept. 103-410 (Oct. 8, 1994).
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`29.
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`The near-ubiquitous ingredient L-carnitine is an oft-discussed example of what
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`could be excluded from the food supply under FDA’s interpretation of the drug exclusion clause
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`of DSHEA that it has applied to NAC. L-carnitine was marketed as both a dietary ingredient and
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`an approved drug prior to the passage of DSHEA. This is an example of exactly why Congress
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`logically intended for supplements and food ingredients that were in the relevant markets prior to
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`DSHEA to continue to be marketed as dietary ingredients (even if those ingredients could
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`simultaneously be marketed as drugs under DSHEA’s rubric) after the effective date of DSHEA,
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`October 15, 1994.
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`30.
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`Under DSHEA, dietary supplement labels cannot claim to treat, cure, prevent, or
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`mitigate a disease, but may include statements or claims of nutritional support, in which “the
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`statement claims a benefit related to a classical nutrient deficiency disease and discloses the
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`prevalence of such disease in the United States, describes the role of a nutrient or dietary ingredient
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`intended to affect the structure or function in humans, characterizes the documented mechanism
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`by which a nutrient or dietary ingredient acts to maintain such structure or function, or describes
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`general well-being from consumption of a nutrient or dietary ingredient . . . .” 21 U.S.C. §
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`343(r)(6)(A). An example of a structure/function claim is the popular dietary supplement St. John’s
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`Wort, which a seller may claim to be a “mood-brightener” but not a cure for depression, which is
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`a specific disease. See, e.g., J. Beisler, DIETARY SUPPLEMENTS AND THEIR
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`DISCONTENTS: FDA REGULATION AND THE DIETARY SUPPLEMENT HEALTH AND
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`EDUCATION ACT OF 1994, 31 Rutgers L.J. 511, 517 n.29 (2000).
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`31.
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`DSHEA also requires that a statement of nutritional support must have
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`“substantiation that such statement is truthful and not misleading” and contain a disclaimer that
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`the “statement has not been evaluated by the Food and Drug Administration. This product is not
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`intended to diagnose, treat, cure, or prevent any disease.” 21 U.S.C. § 343(r)(6)(B)-(C).
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`32.
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`The FDA has recognized that “DSHEA’s purpose [is] to broaden the scope of
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`labeling claims that may be made for dietary supplements without subjecting them to regulation
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`as drugs.” 65 Fed. Reg. 1000-01, 2000 WL 4559, *1024. Consistent with that purpose,
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`substantiation of structure/function claims under DSHEA requires that manufacturers have
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`“competent and reliable scientific evidence,” which has been defined by the FDA and the Federal
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`Trade Commission to include “tests, analyses, research, studies, or other evidence . . . .” Guidance
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`for Industry: Structure/Function Claims, Small Entity Compliance Guide (Criterion 8). Under
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`DSHEA, dietary supplement manufacturers are not required to conduct clinical trials or efficacy
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`testing. See FDA Comment Request, Substantiation for Dietary Supplement Claims Made Under
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`the Federal Food, Drug, and Cosmetic Act, 76 Fed. Reg. 51988-01, 2011 WL 3624830 (2011).
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`III. NAC
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`33.
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`The scientific name for NAC is N-acetylcysteine (also known as N-acetyl-cysteine
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`or N-acetyl-l-cysteine). The naturally occurring amino acid L-cysteine is a precursor to NAC. NAC
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`is naturally metabolized to the antioxidant glutathione. L-cysteine is a semi-essential amino acid.
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`It is considered semi-essential because the human body produces it from two other amino acids,
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`methionine and serine. It becomes essential only when the dietary intake of methionine and serine
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`is suboptimal or deficient. Two other amino acids - glutamine and glycine are used with NAC to
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`make and replenish glutathione. NAC is most notably found in plants of the Allium species,
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`especially in the onion (Allium cepa, 45 mg NAC/kg) along with animal tissue, including chicken
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`skin. The mercapturic acid pathway is a metabolic route for the processing of glutathione
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`conjugates to mercapturic acid (N-acetylcysteine conjugates).
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`34.
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`NAC satisfies the definition of dietary ingredient under Section 201(ff)(1)(F) of the
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`Food, Drug, and Cosmetic Act in that it is a metabolite and constituent of other articles (as noted
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`above) that themselves satisfy the definition of a dietary ingredient under Sections 201(ff)(1)(C),
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`201(ff)(1)(D), and 201(ff)(1)(E) of the Food, Drug, and Cosmetic Act.
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`35.
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`Acetylcysteine was allegedly approved as a mucolytic drug in 1963. It was
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`approved for use solely as an inhalant. An inhalation drug is inhaled as compared to a dietary
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`supplement, which is ingested by humans.
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`36.
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`Among other things, the term dietary supplement means a product that is intended
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`for ingestion. See Section 201(ff)(2) of the Food, Drug, and Cosmetic Act.
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`37.
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`NAC was allegedly approved as a drug as an oral formulation in 1985. This
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`approval was strictly limited to a use as an antidote for acetaminophen poisoning (i.e., as a drug to
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`counteract overdoses of drugs like Tylenol®).
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`38.
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`Despite NAC’s limited applications for which it was approved as a drug, NAC was
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`marketed and sold as a dietary ingredient and a dietary supplement for human ingestion before
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`October 1994. Ex. 1 reflects true and correct copies of evidence that NAC was being marketed and
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`sold as a dietary ingredient and a dietary supplement for ingestion before October 1994. FDA’s
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`own document proves that NAC was marketed and sold as a dietary ingredient and a dietary
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`supplement before July 1993. See Ex. 2, Department of Health and Human Services, Public Health
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`Service, Food and Drug Administration, Unsubstantiated Claims and Documented Health
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`Hazards in the Dietary Supplement Marketplace, July 1993, at page 85 (excerpt referencing a Cell
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`Defense Formula X11 product that contained NAC). Thus, NAC was continuously sold for many
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`years as a food ingredient, dietary ingredient, or dietary supplement after NAC delivery forms
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`were approved as a drug (e.g., as an inhalation product) and before the passage of DSHEA in 1994.
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`In fact, those sales of NAC proceeded unabated until FDA’s very recent objection.
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`39.
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`Hundreds of popular dietary supplement products containing the dietary ingredient
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`NAC have been on sale in the United States to consumers who have come to rely on them.
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`40.
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`NAC is safe to use. There is no evidence in the public record that NAC is harmful
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`or injurious to consumers when the supplement is used as directed. Certainly, the FDA has never
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`suggested that NAC is an unsafe product. In fact, the National Institute of Health has noted that
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`NAC has been sold as a drug and supplement and that NAC is safe. See Ex. 3.
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`IV.
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`THE FDA HAS IMPROPERLY DECIDED THAT DSHEA’S DRUG EXCLUSION
`PROVISION MUST BE RETROACTIVELY APPLIED WITH RESPECT TO NAC.
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`41.
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`The FDA has represented to the public—and a member of Congress—that it has
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`not made any final decision on the regulatory status of NAC. See, e.g., Exs. 4-8. However, FDA
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`has definitively interpreted DSHEA to mean and require that, among other things, the drug
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`exclusion provision has retroactive effect, and that interpretation and application by the FDA is
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`final agency action on the issue as it applies to NAC.
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`A.
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`Blackstone Case
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`42.
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`FDA and the Department of Justice have interpreted DSHEA and its drug provision
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`to apply retroactively to NAC in a criminal action in the U.S. District Court for the Southern
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`District of Florida, captioned United States v. Braun, et al., Case No. 19-80030-CR. The docket in
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`that case is available on Pacer.gov and is incorporated by reference in its entirety.
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`43.
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`On February 3, 2017, the government applied for search warrants for Blackstone
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`Labs, LLC and VBS Laboratories, LLC, supported by an affidavit of Kelly McCoy, a Special
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`Agent with FDA’s Office of Criminal Investigations. Agent McCoy swore under oath that products
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`containing NAC are excluded from the definition of dietary supplements:
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`The Blackstone website also lists for sale other products that violate the FDCA,
`including products named “Gear Support” and “PCTV.” The website includes
`images of each product and their labels. According to the products’ labels, Gear
`Support and PCTV contain N-Acetyl-Cysteine (“NAC”) and are described as
`dietary supplements.
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`Products that contain NAC are excluded from the definition of dietary supplement
`under 21 U.S.C. § 321(ff)(3)(B)(i) because FDA approved NAC as a “new drug”
`in 1985 and FDA does not have any information that indicates that NAC was
`marketed as a dietary supplement or as a food prior to its approval as a “new drug.”
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`Ex. 9 ¶¶ 106-07. Agent McCoy concluded that there was probable cause to believe that Blackstone
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`introduced unapproved “new drug” products into interstate commerce in violation of 21 U.S.C. §
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`331(d). Id. ¶ 111. The search warrants were approved and executed.
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`44.
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`On March 7, 2019, Blackstone and others were indicted for, among other things,
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`violating § 331(d) based on sales of products containing the “new drug” NAC. See Ex. 10 (counts
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`1 and 2). On September 19, 2021, the defendants moved to suppress evidence obtained during the
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`execution of the search warrants. The motion specifically challenged the allegations in Special
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`Agent McCoy’s affidavit. See Ex. 11. The government’s opposition to the motion argued that the
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`affidavit was not misleading in describing NAC as a drug. See Ex. 12 at 13. Defendants filed a
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`reply that contested the government’s arguments. See Ex. 13 at 9-10. The Court denied the motion
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`to suppress on October 21, 2021.
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`45.
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`Should the FDA seek to assert that it has not reached a final agency action in its
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`determination as to NAC’s categorization as dietary ingredient that is excluded from the definition
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`of a dietary supplement because it was marketed as a drug before it was marketed in a food or in
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`a dietary supplement, this is belied by FDA’s actions and determinations in the Blacksone case. If
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`FDA attempts to assert that it has not yet reached any final agency actions or determination as to
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`whether NAC is a lawful ingredient in dietary supplements and what potential regulatory action
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`FDA might take regarding NAC-containing products, these representations or assertions would be
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`contradicted by the statements made to the Court in the pending criminal case cited above. The
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`FDA has repeatedly taken the position that NAC is a new drug and cannot fall within the definition
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`of a dietary supplement, most recently in the opposition to the defendant’s motion to suppress filed
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`October 4, 2021. The FDA cannot continue to claim that it has not yet formulated a determination
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`of NAC’s regulatory status – and taken final agency actions based on it, when NPA’s members
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`have sought clarity on this issue. In fact, the FDA has taken final agency action as evidenced by
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`its unambiguous representations to the Court in the Blackstone case, thereby establishing FDA’s
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`final agency action ripe for review under the Administrative Procedure Act.
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`B.
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`FDA Warning Letters
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`46.
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`On or about July 23, 2020, FDA sent warning letters to four companies regarding
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`their sale of certain products that included NAC as a dietary ingredients. Exs. 14-17.
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`47.
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`The warning letters concluded that:
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`[Y]our product could not be a dietary supplement, because it does not meet the
`definition of dietary supplement under section 201(ff) of the Act [21 U.S.C. §
`321(ff)]. FDA has concluded that NAC products are excluded from the dietary
`supplement definition under section 201(ff)(3)(B)(i) of the Act [21 U.S.C. §
`321(ff)(3)(B)(i)]. Under this provision, if an article (such as NAC) has been
`approved as a new drug under section 505 of the Act [21 U.S.C. § 355], then
`products containing that article are outside the definition of a dietary supplement,
`unless before such approval that article was marketed as a dieta