Could Idaho exempt in-state nutritional and therapeutic products from federal regulation through the Health Supplements and Therapeutics Protection Act ballot initiative?

Plain-English summary

A petitioner filed a 2010 Idaho ballot initiative to enact a "Health Supplements and Therapeutics Protection Act" that would have banned federal regulation of "nutritional or therapeutic products" manufactured in Idaho and sold only within Idaho. The definition of "nutrition or therapeutic product" was broad enough to cover not just dietary supplements but also pharmaceutical and biological products and possibly controlled substances.

The Attorney General's Certificate of Review concluded the initiative was unconstitutional on its face. The Supremacy Clause of the U.S. Constitution (art. VI) makes federal law "the supreme law of the land." A state law that conflicts with valid federal law is "without effect." The proposed initiative would have directly conflicted with several active federal regulatory schemes, including the federal Food, Drug, and Cosmetic Act, the Dietary Supplement Health and Education Act, and the Comprehensive Drug Abuse Prevention and Control Act.

The petition tried to stay inside state authority by limiting the carve-out to products "manufactured in Idaho" and kept "within the orders of Idaho." The AG explained that this intrastate limitation would not save the law. Under M'Culloch v. State of Maryland (1819) and Gonzales v. Raich (2005), Congress can regulate purely intrastate activity that, taken together, substantially affects interstate commerce, and the Supreme Court has long treated drug manufacture and distribution as falling inside that power. Federal statutes like 21 U.S.C. § 331 (the FDCA's prohibited-acts section) and 21 U.S.C. § 379r (national-uniformity clause for nonprescription drugs) explicitly cover intrastate conduct and explicitly preempt inconsistent state rules. A reviewing court would likely find the initiative without effect even if it passed.

The Certificate also noted two technical drafting issues: the word "regulation" appeared to be a typo for "regulate," and the document used both "nutrition or therapeutic product" and "nutritional or therapeutic product" interchangeably. The AG took no position on the underlying policy question of how dietary supplements should be regulated.

Currency note

This opinion was issued in 2010. Subsequent statutory amendments, court decisions, or later AG opinions may have changed the analysis. Treat this page as historical context, not current legal advice. Verify current law before relying on any specific rule, deadline, or remedy mentioned here.

Common questions

What does the Supremacy Clause actually say?

Article VI of the U.S. Constitution declares that the Constitution and federal laws made under it "shall be the supreme law of the land; and the judges in every state shall be bound thereby, anything in the Constitution or laws of any state to the contrary notwithstanding." Chief Justice Marshall's opinion in M'Culloch v. State of Maryland (1819) gave the modern reading: state law that conflicts with valid federal law is "without effect."

Why does an "intrastate only" limit not save the initiative?

Two reasons. First, Congress's commerce power, as the Supreme Court explained in Gonzales v. Raich (2005), reaches intrastate activities that substantially affect interstate commerce. The Court applied this directly to intrastate marijuana production and consumption. Drug manufacture and distribution generally fall within that reasoning. Second, several federal drug statutes are written specifically to cover intrastate conduct (21 U.S.C. § 331) and some explicitly preempt state rules that diverge from federal ones (21 U.S.C. § 379r). An "intrastate only" carve-out at the state level cannot override federal statutes that already reach intrastate conduct.

What federal statutes did the AG identify as conflicting?

The federal Food, Drug, and Cosmetic Act (FDCA, 21 U.S.C. § 331 et seq.); the Dietary Supplement Health and Education Act (DSHEA); and the Comprehensive Drug Abuse Prevention and Control Act (the Controlled Substances Act, the statute interpreted in Gonzales v. Raich).

What about the Tenth Amendment argument that often accompanies these "freedom act" initiatives?

The Certificate doesn't engage the Tenth Amendment in detail. The standard answer is that the Tenth Amendment reserves powers "not delegated to the United States by the Constitution," and the Supreme Court has long held the Commerce Clause is one of the powers delegated. So once a federal statute is a valid exercise of the commerce power, the Tenth Amendment does not give a state the power to displace it.

Did the AG approve or oppose the policy?

Neither. The Certificate is a legal-form review under Idaho Code § 34-1809. The AG explicitly takes no position on the policy of how supplements should be regulated.

Background and statutory framework

The Certificate of Review process under Idaho Code § 34-1809 requires every initiative petition to receive a written legal review from the Attorney General before petition signatures can be circulated. The review covers form, style, and substantive legal problems including any constitutional defects. The AG's recommendations are advisory; the petitioner can accept or reject them. The AG explicitly does not weigh in on policy.

The substantive analysis here is standard preemption doctrine. The Supremacy Clause makes federal law supreme; preemption invalidates conflicting state law (as the AG notes, citing the Idaho Supreme Court's decision in Zimmerman v. Volkswagen of America, Inc.). The federal drug regulatory regime (FDCA, DSHEA, CSA) was enacted under Congress's Commerce Clause power. Gonzales v. Raich (2005) confirmed Congress can reach intrastate drug production and consumption that, in the aggregate, substantially affects interstate commerce. Some federal statutes go further: 21 U.S.C. § 331 lists prohibited acts that cover intrastate conduct, and 21 U.S.C. § 379r preempts state regulation of nonprescription drugs that differs from federal rules.

A wave of similar "Health Freedom Act" or "Firearms Freedom Act" or "[Topic] Freedom Act" initiatives appeared in many states around 2009 and 2010, all using the same intrastate-commerce-only structure. Federal courts have generally rejected the theory.

Citations

U.S. Constitution: art. VI.

Idaho Code: § 34-1809.

Federal statutes: 21 U.S.C. § 331; 21 U.S.C. § 379r.

Cases: M'Culloch v. State of Maryland, 17 U.S. 316 (1819); Zimmerman v. Volkswagen of America, Inc., 128 Idaho 851, 920 P.2d 67 (1996); Gonzales v. Raich, 545 U.S. 1 (2005); Deyo v. United States, 396 F.2d 595 (9th Cir. 1968).

Source

• Landing page: https://www.ag.idaho.gov/office-resources/opinions/
• Original PDF: https://ag.idaho.gov/content/uploads/2018/04/C020310.pdf

Original opinion text

STATE OF IDAHO
OFFICE OF THE ATTORNEY GENERAL
LAWRENCE G. WASDEN

February 3, 2010

The Honorable Ben Ysursa
Idaho Secretary of State
STATEHOUSE MAIL

Re: Certificate of Review
Proposed Initiative Relating to the Health Supplements and Therapeutics
Protection Act

Dear Secretary of State Ysursa:

An initiative petition was filed with your office on January 19, 2010. Pursuant to
Idaho Code § 34-1809, this office has reviewed the petition and has prepared the
following advisory comments. Given the strict statutory timeframe within which this
office must review the petition, our review can only isolate areas of concern and cannot
provide in-depth analysis of each issue that may present problems. Further, under the
review statute, the Attorney General's recommendations are "advisory only." The
petitioners are free to "accept or reject them in whole or in part." The opinions
expressed in this review are only those that may affect the legality of the initiative. This
office offers no opinion with regard to the policy issues raised by the proposed initiative.

BALLOT TITLES

Following the filing of the proposed initiative, this office will prepare short and
long ballot titles. The ballot titles must impartially and succinctly state the purpose of
the measure without being argumentative and without creating prejudice for or against
the measure.

MATTERS OF SUBSTANTIVE IMPORT

At the outset, I note that there is a typographical error in the proposed initiative
("Initiative"). The last sentence of Section 29-9102 states, "[t]his Act shall not be construed
to limit the State of Idaho's ability in its capacity to regulation pharmaceutical or biologic
therapeutics." (Emphasis added) I believe that the sponsors intended to state "regulate"
instead of "regulation." If this is correct, the sponsors should correct this error.

Further, in Section 29-9103, the Initiative defines "Nutrition or therapeutic product."
Other sections of the Initiative refer to "nutritional or therapeutic product." (Emphasis
added.) The Initiative should be drafted so that the term is consistent throughout its
language.

The Initiative is Inconsistent with the United States Constitution and Federal Laws:

The Initiative seeks to prohibit federal law or regulation of "nutritional or therapeutic
products" that are manufactured in Idaho and that remain within the orders of Idaho.
"Nutrition or therapeutic product" is defined broadly in Section 29-9103(b) of the Initiative, so
as to include pharmaceutical, biological, and "nutritional" supplements. As worded, this
definition could include not only pharmaceutical and dietary supplement products, but also
controlled substances or "illegal drugs."

The Initiative is inconsistent with the U.S. Constitution. Article VI of the U.S.
Constitution, commonly referred to as the "Supremacy Clause," states, in part:

This Constitution, and laws of the United States which shall be made in
pursuance thereof; and all treaties made, or which shall be made, under the
authority of the United States, shall be the supreme law of the land; and the
judges in every state shall be bound thereby, anything in the Constitution or
laws of any state to the contrary notwithstanding.

The U.S. Supreme Court has held that state laws that conflict with federal law are "without
effect" under this Article. As the U.S. Supreme Court explained in M'Culloch v. State of
Maryland, 17 U.S. 316, 1819 WL 2135 (U.S. Md.), 4 L. Ed. 579 (1819):

The people of the United States have seen fit to divide sovereignty, and to
establish a complex system. They have conferred certain powers on state
governments, and certain other powers on the national government. As it was
easy to foresee that question must arise between these governments thus
constituted, it became of great moment to determine, upon what principle
these questions should be decided, and who should decide them. The
constitution, therefore, declares, that the constitution itself, and the laws
passed in pursuance of its provisions, shall be the supreme law of the land,
and shall control all state legislation and state constitutions, which may be
incompatible therewith ... The laws of the United States, then, made in
pursuance of the constitution, are to be the supreme law of the land, anything
in the laws of any state to the contrary notwithstanding.

M'Culloch, 17 U.S. at 326-27. The Idaho Supreme Court has ruled consistently. See, e.g.,
Zimmerman v. Volkswagen of America, Inc., 128 Idaho 851, 920 P.2d 67 (1996), cert.
denied, 520 U.S. 1115, 117 S. Ct. 1245, 137 L.Ed.2d 327 (1997) ("It is well settled that any
state law which conflicts with federal law is 'without effect' as provided under the Supremacy
Clause of the United States Constitution.").

This Initiative has the potential to conflict with a number of federal laws, including but
not limited to, the federal Food, Drug, and Cosmetic Act, the Dietary Supplement Health and
Education Act, and the Comprehensive Drug Abuse Prevention and Control Act. Because
of this conflict, it will be considered "without effect."

The Initiative's limitation to intrastate activities does not remedy the Supremacy
Clause issue. Congress is authorized to regulate intrastate activities that substantially affect
interstate commerce, and courts have held that the regulation of drugs falls within that
category. See Gonzales v. Raich, 545 U.S. 1, 125 S. Ct. 2195, 162 L.Ed.2d 1 (2005)
(holding that the application of the federal Controlled Substances Act provisions criminalizing
the manufacture, distribution or possession of marijuana to intrastate growers and users did
not violate the Commerce Clause); Deyo v. United States, 396 F.2d 595 (9th Cir. 1968)
(holding that the application of the federal Food, Drug, and Cosmetic Act provisions
criminalizing LSD regardless of whether the drug crossed state boundaries is constitutional).

In addition, certain federal laws governing the manufacture, sale, and distribution of
drugs clearly apply not only to interstate activities, but to intrastate activities as well. See,
e.g., 21 U.S.C. § 331 (2009) (prohibited acts and penalties under the federal Food, Drug,
and Cosmetic Act). There are also federal laws specifically precluding states from
establishing regulations regarding drugs that are different from the federal laws. See, e.g.,
21 U.S.C. § 379r (1997) (statute regarding national uniformity for nonprescription drugs). An
Idaho state law cannot "override" or preempt such laws. A court would likely rule that the
Initiative, if passed, was without effect regardless of its limitation to intrastate activities.

CERTIFICATION

I HEREBY CERTIFY that the enclosed measure has been reviewed for form, style,
and matters of substantive import. The recommendations set forth above have been
communicated to the Petitioner via a copy of this Certificate of Review, deposited in the U.S.
Mail to Alanna Grimm, 2817 E. St. James Ave., Hayden, Idaho 83835-7544.

Sincerely,

LAWRENCE G. WASDEN
Attorney General

Analysis by:
JANE E. HOCHBERG
Deputy Attorney General