Regulating ‘natural’ - the FDA did what? (Michaela Oldfield)

Regulating ‘natural’ - the FDA did what?

By Michaela Oldfield / Global Research Fellow

As I noted in my post on FDA’s approval of AquaAdvantage, the labelling of foods is a major hot-button issue in the current controversy over genetic engineering technologies and our food system.

The week before the FDA’s salmon action, the agency issued a Federal Register notice requesting comments on the use of the term natural on food labels.  80 Fed. Reg. 69905 (November 12, 2015).

The general consensus is this is potentially a really major move by the FDA, and somewhat unexpected. For more analysis of how this is a major, unexpected move by the FDA - Foodnavigator has a story with industry interviews and Lexology has a piece covering the potential litigation impacts of the action and potential internal benefits for companies if FDA finalizes a rule. There’s also a room for debate over at the New York Times from last year providing various perspectives on the policy implications of the decision.

Again, rather than rehash others’ words and thoughts, I’m going to focus this blog on a basic discussion of some legal issues that food law students should understand. This might seem repetitive for anyone who has taken US Food Laws but it’s important to review how the law permits and constrains FDA’s actions.

For beginners, this is the first step for the agency in potentially issuing a rule pursuant to the Administrative Procedure Act (APA), 5 U.S.C. § 551 et seq. This is the primary piece of legislation governing regulatory agencies’ behavior. Combined with several judicial decisions that I will not go into here, this law requires agencies to follow prescribed procedures if they are issuing a rule that is expected to have a binding legal effect.

Generally, before issuing a rule, the agency must provide notice of the potential rule and opportunity for the public to comment. Once the agency has accepted comments, they will need to issue a proposed rule, accept comments, and issue a final rule at least 30 days before it goes into effect.

Agencies are not just limited in how they go about issuing rules; there are also limits on what they can issues rules on. Legislating is supposed to be Congress’s job, so agencies carry out rulemaking under authority delegated to them from Congress. An agency can only  issue rules under an authorizing statute that gives them permission to do so. The law that gives the FDA authority to regulate the use of the term ‘natural’ is the Food, Drug and Cosmetics Act (FDCA). 21 U.S.C. § 321 et seq.

A key component of the FDCA is the prohibition on sales of food that are misbranded. 21 U.S.C. § 331(a). A food is considered misbranded if the labelling is false or misleading in any particular. 21 U.S.C. §  343(a)(1).
 

The FDA’s action is a request for comments to potentially write a regulation that will define when the use of the word natural on a label would be misleading, making the food misbranded and thus a violation of the FDCA.

It is important to understand some of the ways food labelling can be misleading. I’ll give two examples taken from Neal Fortin’s Food Regulation case book which relate to some of the questions the FDA asked in its request for comments.

First, from whose perspective should we assess whether labelling is misleading. In a ruling on whether the USDA’s regulations for “all meat” sausages was misleading and deceptive the D.C. Circuit Court of Appeals asked “do the words ‘all meat’ mean to an ordinary consumer, as distinguished from an expert, that a frankfurter in a package on which these words appear contains 85 percent meat and other components, and not 81½ percent meat and other components?” Federation of Homemakers vs. Butz, 466 F.2d 462 (D.C. Cir. 1972). So for determining whether a label is misleading, we need to examine it from the perspective of an ordinary consumer, as opposed to an expert.

While we can debate (and litigate) who is an “ordinary” consumer, an ordinary consumer is NOT your legal department or your marketing department.

Some of the questions in FDA’s request for comments are asking for comments and evidence on how ordinary consumers interpret and understand natural labelling. This will then factor into the FDA’s decision about whether regulating the use of the term is necessary, and if so, how to regulate the use of the word so that it is used in a manner consistent with consumer understanding.

Second, when does the method of production matter for determining if the label is misleading?

Generally, labelling is not meant to address production practices. For instance, in a case concerning apple cider vinegar, the Supreme Court stated, “When considered independently of the product, the method of manufacture is not material. The act requires no disclosure concerning it. And it make no difference whether vinegar made from dried apples is or is not inferior to apple cider vinegar.” United States v. 95 Barrels of Alleged Cider, 265 U.S. 438 (1924).

In that case, the labelling claimed the vinegar was made from “special, selected apples” when it was in fact made from dried and reconstituted apples. By the letter of the law and regulations, this made no difference - the label was technically accurate and in compliance with FDA’s requirements to be labeled as apple cider vinegar. However, the phrasing “special, selected apples” implied fresh apples, and so the court deemed the label misleading for consumers.

The issue with natural labels is whether the production practices used to grow crops - namely, GMOs and synthetic pesticides and fertilizers - can make the use of the term natural misleading. Under FDA’s current policy, production practices don’t matter.

So why is the FDA considering taking action now -- 20 years after having initially studied the matter?

Lawsuits! Several courts are currently handling class action labelling lawsuits about consumers’ understanding of the use ofnatura and the production practices of the the use of GMOs in foods labelled natural. This means issues of ordinary consumers’ perspective on what constitutes natural, and whether and how production practices matter, could be decided in the courts through litigation.

By taking action, the FDA could circumvent haphazard and inconsistent policy-making and instead establish a uniform, national standard for the use of natural terms in labelling.

FDA is also taking this action in part because several courts have requested that the FDA issue an administrative determination on whether the presence of GMOs makes a ‘natural’ label misleading. Other courts have chosen to move forward with litigation, in essence choosing to determine the point of law themselves rather than ask for agency guidance.

This raises some administrative law question about the allocation of authority between Congress, the courts, and the executive. I will leave you with these:

• Why would, and should, courts request that FDA make an administrative decision on this issue?
• If FDA does make a determination, do courts have to defer to the agency’s interpretation?
• More broadly, when should(n’t) courts defer to executive actions taken pursuant to a delegation from Congress?
  
  Footnotes
  1 And that’s just the start! If you look at the litany of labelling restrictions, you can see just how easy it is to go wrong if you aren’t careful. Other ways a food can be misbranded are:
• if it is offered for sale under the name of another food 21 U.S.C. 343(b)
• if it is an imitation of another food and does not have “imitation  ______” on its label 21 U.S.C. 343(c)
• it the container is misleading 21 U.S.C. 343(d)
• if the packaging does not provide the name and address of the manufacturer, packer or distributor or an accurate statement of the quantity 21 U.S.C. 343(e)
• if information is not sufficiently prominently displayed 21 U.S.C. 343(f)
• if it doesn’t meet the requisite standard of identity (if there is one). 21 U.S.C. 343(g)
• if it doesn’t meet the standard of quality (if there is one). 21 U.S.C. 343(h)
• if it fails to provide the common or usual name of the food (where there is no standard of identity) 21 U.S.C. 343(i)
• if it represents to be for special dietary use and the label doesn’t contain required information prescribed by regulation 21 U.S.C. 343(j)
• if it contains artificial flavoring, artificial coloring, or chemical preservatives and doesn’t mention it in the labeling 21 U.S.C. 343(k)
• if any pesticide chemicals were applied after a raw agricultural commodity was harvested and the shipping container does not declare the pesticide’s presence 21 U.S.C. 343(l)
• if it's a color additive and doesn’t say so 21 U.S.C. 343(m)
• if it doesn’t provide correct nutrition information 21 U.S.C. 343(q)
• it it has inaccurate information concerning nutrition levels or health-related claims 21 U.S.C. 343(r)
• if it is a dietary supplement and doesn’t follow the special dietary supplement labelling guidelines 21 U.S.C. 343(s) [this popped up in my news feed recently and may merit another post soon]
• if it purports be catfish and it isn’t 21 U.S.C. 343(t)
• if it purports to be ginseng and it isn’t 21 U.S.C. 343(u)
• if it the FDA determines its a health threat and doesn’t have a label about it 21 U.S.C. 343(v)
• if it fails to label that it contains a food allergen 21 U.S.C. 343(w) & (x)
  
  
  2 Nothing in the request guarantees that the FDA will take any further action soon (or even ever). For instance, the FDA previously accepted comments on defining the term back in 1991. 80 Fed. Red. 69905 at 69906 (citing 56 Fed. Reg. 60421 at 60466 (November 27, 1991)). In 1993, the agency decided to not make any changes. Instead, they continued their existing policy of considering “natural” to mean that ‘nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to in the food”. Id. at 69906 ((citing 58 Fed Reg 2301 at 2407, January 6, 1993)).
  
  

  3 They were. Though technically the regulation was determined invalid because USDA had not provided a reasonable basis for their labelling standard.

FDA’s AquaAdvantage approval - Understand the law, evaluate the politics of policy change (Michaela Oldfield)

FDA’s AquaAdvantage approval

Understand the law, evaluate the politics of policy change

By Michaela Oldfield

Several weeks ago, the FDA released its approval of AquaAdvantage salmon. Food and ag lawyers at other blogs quickly jumped in with analyses and further information on the action.

For our students, I want to highlight several components of the approval that I think they should understand and examine. The goal with this post is to highlight the sources of law governing FDA’s action and provide a brief explanation of the legal rationale that produced the outcome.

First, the Approval is for AquaAdvantage as a new animal drug - this makes it a different procedure than what commercially available GE Crops have gone through. Here’s a little chart summarizing the differences:

Agency	GE Crops	GE Salmon
FDA	Considered “substantially equivalent” to non-GE crops; manufacturers may voluntarily request FDA review of GRAS determination	new drug approval
EPA	Review as a pesticide if the plant is engineered to endogenously produce a pesticide	n/a
USDA	APHIS review of plant pest risk	n/a
FWS	generally N/A, unless potential to impact endangered species	Section 7 ESA consultation with FDA because of potential impact on endangered Atlantic salmon

The GE salmon is being approved through the NADA process because the gene expression therapy qualifies as a drug under 201(g)(1)(C) of FDCA, which defines a drug as “articles (other than food) intended to affect the structure or any function of the body of man or other animals”.

In class, a teacher might ask if can you construct a legal argument that the salmon should be approved as a food or an additive, rather than a drug? In the world of food and drug law, this is an important argument to be able to make because the distinctions between a food, a drug, and an additive are high-stakes issues due to the differences in the regulatory regime for each item.

To make your argument, you need to start with the definitions in the law, which are codified at 21 U.S.C. 321:

• (f) The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
• (g)(1) The term “drug” means ...(C) articles (other than food) intended to affect the structure or any function of the body of man or other animals

With those definitions alone you can’t distinguish between a food and a drug. So you then need to go to case law to see how the courts interpret and apply that distinction.

A seminal case distinguishing a food from a drug is Nutrilab, Inc. v. Schweiker, 713 F.2d 335 (1983), in which starch blockers derived from beans were determined to be a drug because they “were not consumed primarily for taste, aroma, or nutritive value.” (This is only one case being given as an example - if you want to convince a judge, you would need a lot more than this!). So the rDNA technology affects the structure and function of the fish, and it's not being consumed for taste, aroma, or nutritive value and so it's arguably not a food.

But is there an argument the new gene it creates in the salmon is a food additive? In 21 USC 321(s) the term “food additive” means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food.

Food and Water Watch tried to argue the salmon should be reviewed as a food additive and denied approval as not “generally recognized as safe” (GRAS) because the “process significantly alters the salmon’s composition... in a way that is reasonably expected to alter its nutritive value or concentration of constituents, and the new substance raises safety concerns.” Citizen Petition To Deem AquaBounty Technologies’ Genetically Engineered AquAdvantage Salmon An Unsafe Food Additive, p 2.

By the FDA’s regulation, if a food that is commonly consumed for its nutritive value “has had significant alteration of composition by breeding or selection...where the change may be reasonably expected to alter the nutritive value or the concentration of constituents” it must be “reviewed as and affirmed as GRAS or determined to be a food additive . . . .”21 C.F.R. § 170.30(f)(2) (2014).

FDA rejected FWW’s argument on the grounds that the salmon can not be approved as a drug and a food additive, and must necessarily undergo the drug approval process. Further, as part of the safety evaluation for the approval of a new animal drug, the FDA must evaluate the potential risks of “any substance formed in or on food because of the use of [the] drug” 21 U.S.C. 360b(d)(2)(a). FDA evaluated the salmon and the Gene Expression Product that resulted from use of the rDNA technology, and found AquaAdvantage salmon are as safe to eat as conventional salmon. FDA used this analysis as part of its justification for rejecting FWW’s petition to have the salmon declared an unsafe adulterant.

In addition to the FDCA, FDA’s approval process is also subject to requirements under the National Environmental Procedure Act (NEPA) and Endangered Species Act (ESA). As required by their regulations, the FDA produced an environmental assessment (EA) of the likely impacts of the approval, and reached a Finding of No Significant Impact (FONSI).

Accompanying the EA, the FDA also carried out a Section 7 ESA consultation with relevant federal agencies (see pages 9-10 and 135-136 of EA).  In short, the company will be breeding sterile stock in conditions that, if they escaped, they would die, and then transporting and raising them in Panama where they would also be expected to die if they escaped. As a result of the FONSI, the agency does not have to prepare a full Environmental Impact Statement.  

Some might not think of NEPA or the ESA as “food laws,” because on their face they appear to be environmental laws. However, they are important components of administrative law to know of because they are far-reaching statutes that can significantly slow down, stop, or force repeal of agencies’ actions.

Students should note, the approval is only for production of the salmon under very specific conditions. If anyone wants to breed or raise the salmon in any other locale or method than FDA approved here, they would have to go through the NADA approval process again.

In addition to analyzing what the law is and how it works, lawyers and policy wonks ought to also talk about what goals or purpose the law should serve and whether and how it needs to be changed to achieve that goal.

One way to think about this is to ask, does the current approval process for GE foods properly balance risks and benefits? Factors one might want to consider are:

• What are the major environment and health concerns and what data is needed to evaluate those concerns?
• What would be the time and financial cost of collecting and analyzing data to support review? Are those costs worth it given the risks?
• Who should be collecting and reviewing the data?
• Is there adequate opportunity for all stakeholders’ input?
• How will risks and benefits be distributed?

A hot botton issue related to the GE salmon approval is the labelling of GE foods. Accompanying the AquaAdvantage approval, FDA also issued final guidance on labelling foods derived from GE technologies and draft guidance on labelling Salmon.  

As you surely know, there are also several other labelling law issues pending across the country. Vermont’s legislation on the mandatory labelling of GE foods is facing a federal court challenge; a number of consumer class actions on ‘natural’ labelled GE foods are in state courts; FDA recently solicited comments on the use of the term natural in labelling GE foods (more on that in my next post); and the appropriations bill that Congress just released did not contain a hotly contested rider to preempt state GE labelling laws.

Are FDA’s voluntary labelling guidelines sufficient to overcome any issues raised by the earlier questions? If not, what kind of law or policy would be more effective? Why, and what are the possible implications of those alternative laws? For instance, Vermont's legislation raises the spectre of patchwork legislation that undermines the national uniformity of FDA labelling rules. This issue, and whether Vermont’s law is even legal, is an issue I will come back to in a few weeks with a post on some recent food law preemption cases.

* * *

If you would like to delve into the approval and regulations, the online GFLP offers two courses on biotech regulations: 810P Biotechnology Law and Food Products (2 credits) and 810N Survey of Intellectual Property in Agriculture (3 credits).