For the first time in 25 years, the Food and Drug Administration (FDA) announced a plan to modernize dietary supplement regulation and oversight.

The announcement sets lofty goals and articulates the following priorities:

  1. Communicate to the public as soon as possible when there is a safety concern about a dietary supplement on the market.
  2. Ensure FDA’s regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation.
  3. Continue to work closely with industry partners, and engage in a public dialogue to get valuable feedback from dietary supplement stakeholders.
  4. Develop new enforcement strategies.

On the same day as the announcement, the agency issued over a dozen Warning Letters and advisory letters to companies marketing products as dietary supplements but that FDA considered to be intended for unapproved disease indications, such as claims about the prevention of Alzheimer’s disease. Following the regulatory letters issued the day of the announcement, FDA has issued an additional 11 Warning Letters to companies marketing products with 1,5-Dimethylhexylamine (DMHA) and phenibut, because FDA asserts that the products at issue are being unlawfully marketed as dietary supplements. The agency also has taken many similar actions in recent years, including sending Warning Letters to companies marketing supplements containing concentrated caffeine, male enhancement drugs, and tianeptine, as well as for violations of the current good manufacturing practice (cGMP) regulation for dietary supplements.

In addition to these enforcement actions, FDA has formed a Dietary Supplement Working Group to create strategic priorities for dietary supplements and ensure FDA is focusing its efforts and resources in the right way. FDA also announced that the agency is creating a Botanical Safety Consortium to promote scientific innovation in evaluating the safety of botanical ingredients and mixtures, modernizing the process for submitting new dietary ingredient notifications (NDINs), and addressing other barriers to innovation, such as establishing a scheme for supplement exclusivity.

First Steps towards Modernization

FDA is hosting a public meeting on Thursday, May 16, 2016 in College Park, MD as a first step to implementing this plan. The meeting will allow stakeholders an opportunity to present ideas to the agency on these proposed plans. FDA has identified the following topics to be discussed during the meeting:

  1. The scope of the phrase “dietary substance for use by man to supplement the diet by increasing the total dietary intake” as used in the Dietary Supplement Health Education Act of 1994 (DSHEA), which determines, in part, whether a product meets the definition of a dietary supplement.
  2. Understanding the exceptions to the premarket notification requirements for dietary supplements, and whether and how growth in the dietary supplement marketplace since 1994 has altered the impact of DSHEA.
  3. Ways to incentivize responsible innovation through potential commercial or market advantages.
  4. Use of enforcement to promote overall compliance with the premarket notification requirement.

Individuals interested in attending the public meeting in person and testifying may register with FDA by May 6. The meeting will also be streamed via webcast, but FDA suggests individuals attending online preregister as well.

Rapid Response Tool

FDA also recently unveiled a new Dietary Supplement Ingredient Advisory List. This is a rapid response tool that is meant to alert the public and supplement industry when FDA identifies ingredients that do not appear to be lawfully marketed in dietary supplements, but does not necessarily indicate that the ingredient is unsafe. The list is generated based upon a preliminary assessment by FDA that the ingredient appears to be excluded from use in dietary supplements, does not appear to be a dietary ingredient and is not an approved food additive or generally recognized as safe (GRAS) for use, or was not subject to the required pre-market notification.

What This Means to You

This is the first time FDA has considered adjusting its approach to the regulation of dietary supplements since DSHEA was first enacted. The public meeting and FDA’s modernization efforts on a broader level present an opportunity for both trade groups and individual companies to understand and influence how FDA will alter the process by which dietary supplements are introduced to the market and how FDA will evaluate their safety. Given FDA’s focus on innovation, it will be especially important for companies developing novel dietary supplements or new dietary ingredients to understand how these potential changes may affect the regulatory process for new products.

Contact Us

Husch Blackwell has experience working with manufacturers and trade groups on important FDA rulemaking. Further, our FDA team regularly advises dietary supplement manufacturers on the regulation of new dietary ingredients and products, and has members with the required scientific backgrounds to help strategize and organize responses. Our FDA regulatory lawyers are available to discuss the announcement and upcoming meeting and how companies can appropriately prepare. Contact Seth Mailhot, Emily Lyons, or your Husch Blackwell attorney.

On September 28, 2018 and December 27, 2018, we blogged about the challenge to Missouri’s meatless meat statute. The statute purports to prohibit designating a product as meat unless it has been obtained from harvested livestock or poultry.  The target of the statute is newly developed technology that can produce from either laboratory or plants a product that looks and tastes very much like meat.  The plaintiffs argue that the statute violates their first amendment rights, because they clearly disclose that the product is either lab-grown or plant-grown.

As we explained on December 27, plaintiffs have moved for a preliminary injunction. The state’s response makes no effort to defend the statute as written.  Instead, it argues that the state Department of Agriculture has interpreted the statute only to prohibit misleading characterizations of a product as meat and that the statute does not prohibit marketing meatless meat as long as its origin is disclosed.

The Department actually issued a statement that it would not exercise its authority under § 265.497, R.S.Mo., to refer producers to the attorney general and the prosecuting attorney in the county where the producer is located. Nothing in the statement binds a prosecutor to refrain from pressing charges under the plain language of the statute.

Under these circumstances, the case is an obvious candidate for a settlement in which the Court enters an injunction incorporating the Department’s statement and enjoining any enforcement effort if the producer plainly discloses the origin of the product. Press reports suggest that the parties are in the process of negotiating exactly that sort of settlement.

In the meantime, five other states have enacted similar legislation and the Montana legislature has passed a bill that the governor is expected to sign. If these statutes merely prohibit marketing of meatless meat without disclosing its origin, they are constitutional and likely will not attract lawsuits.  If they purport to ban the use of the word “meat,” they will be challenged in court and will likely lose.

The issue may soon be moot. The federal Departments of Agriculture and Health and Human Services have agreed on a joint regulatory approach to meatless meat.  Both the Meat Inspection Act and the Poultry and Poultry Products Inspection Act prohibit the states from requiring packaging and warning labels different from or in addition to those prescribed by the Secretary of Agriculture, at least when the Secretary concludes that such differences interfere with commerce.  State efforts to regulate meatless meat may very well be preempted.

Wisconsin is one of the few states that ban the sale of ungraded butter and the only one that enforces the ban. The state allows for four categories of grade: AA, A, B, and Ungraded. To grade butter, an examiner must be licensed by the state or the federal government. The grade depends on each examiner’s subjective application of no less than 32 characteristics involving flavor, color, body and salt. These characteristics are further qualified by intensity – slight, definite or pronounced.

Minerva Dairy is an Ohio-based artisanal maker of Amish-style butter. Minerva alleges that its butter is quite popular and it has sold butter throughout the United States. In 2017, the state informed Minerva that it could not sell ungraded butter in Wisconsin. The characteristics of Minerva’s butter are quite different from those the state envisioned when it enacted the statute and regulations. Thus, it cannot qualify for the top grading of AA. Rather than damage its brand equity, Minerva has chosen not to sell butter in Wisconsin.

In 2017, Minerva sued the state to enjoin the grading scheme. The District Court granted summary judgment for the state and the Seventh Circuit affirmed. Minerva has now filed a petition for certiorari in the Supreme Court of the United States.

The principal basis for the petition is the dormant commerce clause. Courts analyze dormant commerce clause claims under a three-part test: disparate treatment, disparate impact and balancing. A disparate treatment regulation facially discriminates against out-of-state sellers and is almost always unconstitutional. If Wisconsin chose to ban the sale of all out-of-state butter, it would act illegally. A disparate impact regulation is one that is facially neutral but in fact favors in-state sellers. If Wisconsin chose to limit trailer length to 55 feet whereas the states surrounding it allowed 65 feet, the effect of the statute would be to favor in-state trailers because they could legally operate in other states; whereas out-of-state trailer companies could not legally operate 65-foot trailers in Wisconsin.

The third test, as recognized in Pike v. Bruce Church, Inc., 397 U.S. 137 (1970), asks whether the local benefits of a challenged regulation outweigh its adverse effect on interstate commerce. In Pike, a state statute required all cantaloupes grown in Arizona to be packaged in a certain way. Bruce Church instead wanted to ship cantaloupes in bulk to California, where it already had a packing station. The Court held that the burden on Bruce Church substantially outweighed any benefit that Arizona might derive from enforcing its packaging requirement.

Minerva’s petition asserts a Pike claim. Unfortunately for Minerva, the Seventh Circuit has adopted an extremely narrow view of Pike: that court engages in the requisite balancing only if the plaintiff can establish that challenged regulation hits out-of-state sellers more harshly than in-state sellers. As Minerva’s petition points out, this holding largely eviscerates Pike, because a regulation with such a discriminatory effect likely is unconstitutional without regard to Pike’s balancing test. To a greater or lesser degree, the Second, Third and Fifth Circuits agree with the Seventh.

The other circuits do not require that threshold level of proof, although they are by no means consistent in applying Pike. The Sixth and Tenth Circuits closely adhere to Pike’s balancing test. The Eighth Circuit applies the balancing test but with substantial deference to the states. The Ninth Circuit largely ignores Pike.

Minerva had the misfortune to sue in a state in the Seventh Circuit. The Wisconsin grading scheme has precisely the same adverse effect on in-state artisanal butter manufacturers as it does on Minerva. Because Minerva could not demonstrate the discriminatory purpose or effect that the Seventh Circuit requires, its cause was doomed.

Minerva’s second point is that the grading system is so arbitrary and capricious that it violates due process. That is an extremely difficult standard to satisfy because the state does not have to rely on evidence, just hypothetical possibilities about why the statute might serve some public purpose. The Seventh Circuit found two such purposes: informing consumers and protecting the quality of butter.

Minerva’s petition argues that the grading system serves neither purpose, because it provides no objectively verifiable information, just a subjective view of the overall characteristics that the state finds pleasing. Consumers might disagree. Indeed, the petition alleges that Wisconsin consumers often cross state lines to buy Irish butter that is not sold in Wisconsin because it tastes different from the subjective standards the state has imposed.

On two occasions, the petition suggests that the state adopted its butter grading law for the purpose of shielding large, in-state manufacturers of butter from out-of-state competition. If this be true, one wonders why Minerva did not present evidence to that effect in the summary judgment proceedings. Direct evidence of discrimination against out-of-state sellers would satisfy even the Seventh Circuit’s requirements for invoking Pike.

Since 1937, federal courts have paid lip service to the proposition that the right to engage in commerce is one of the inalienable rights referenced in the Declaration of Independence and reserved to the people in the Ninth Amendment. While the Declaration referred specifically only to life, liberty and the pursuit of happiness, there is little doubt that the Founding Fathers would have included economic rights. One of the specifications of King George’s tyranny was cutting off trade with the rest of the world. In practice, however, with few exceptions, judicial review of economic regulation is so deferential as to be virtually nonexistent. I believe that the Founding Fathers would be appalled by a statute that prohibited braiding of hair without a 2,000 hour course in cosmetology.

Minerva’s petition illustrates the damage that overzealous regulation can wreak upon a business. The state of Wisconsin has no more business telling people how butter should taste than the trademark office has in policing trade names that it thinks are offensive. Yet Wisconsin’s grading statute deprives Wisconsin residents of the opportunity to purchase products that they desire, at least within the state.

Moreover, it is all but certain that the impetus behind the grading statute came from Wisconsin butter manufacturers intent on limiting competition. Most restrictions imposed in the name of consumer protection are really disguised efforts to protect the regulated entities from competition.

These days, it is fashionable to deride Lochner v. New York, 198 U.S. 45 (1905), as a foolish effort to prevent states from imposing mandatory hour restrictions for the benefit of workers. In fact, the proponents of that legislation were large, unionized bakers and its targets were the mom-and-pop bakers, usually immigrant, often Jewish, who were perfectly willing to work 16-hour days to get ahead of the competition. The large bakers did not like that competition.

The Trump Administration, through the EPA and Corps, announced its new regulatory definition for WOTUS on December 11, 2018. Shortly after the government shutdown ended earlier this year, the proposed rule appeared in the February 14, 2019, Federal Register and EPA held a public hearing in Kansas City, Kansas, on February 27th and 28th. Much like the CWR, the new rule is said to be intended to clarify the limits of the CWA’s authority. Unlike the CWR, the new rule streamlines rather than adds categories of waters.

Read the full post on our Emerging Energy Insights Blog.

We blogged on March 12, 2018, about the State of Iowa’s appeal of a District Court order finding that its so-called “ag-gag” statute violated the First Amendment.  The statute made it a criminal offense to gain access to farm facilities by false pretenses or to make a knowingly false statement in an employment application.  The purpose is to make it harder for undercover investigations to uncover animal abuse.

Continue Reading Ag-Gag Law Update