Regulatory Comments to Docket No. FDA-2014-N-1207; Notification of Request for Comments: Use of the Term “Natural” in the Labeling of Human Food Products. 80 Fed Reg 69905-69909Regulatory Comments to Docket No. FDA-2014-N-1207; Notification of Request for Comments: Use of the Term “Natural” in the Labeling of Human Food Products. 80 Fed Reg 69905-69909
Date: Nov 30, 2015
Background:
The regulation of the entire food industry in the United States is covered by three federal agencies with unique jurisdictions and various state and local governments. The USDA, FDA, and FTC have ultimate regulatory authority of interstate commerce when foods make any claims using the term “natural”. USDA is responsible for labels on meat, poultry, and processed eggs; FDA’s Center for Food Safety is responsible for labels on all other conventional foods, beverages, and dietary supplements, amounting to approximately 80% of the nation’s food supply; and the FTC is responsible for food advertising. The historic role that each of these three agencies have taken in shaping “natural” will be discussed below.
USDA. FSIS is the public health regulatory agency in the USDA responsible for ensuring that the nation’s commercial supply of meat, poultry, and egg products is safe, wholesome, and truthfully labeled and packaged. In particular, FSIS develops and implements national policies to ensure that meat, poultry, and egg product labeling is truthful and non-misleading. To guide manufacturers in the development of labeling that FSIS was likely to determine to be truthful and not misleading with regard to the voluntary claim ‘‘natural,’’ FSIS published policy guidance in the form of Standards and Labeling Policy Memorandum (Memo) 055, dated November 22, 1982. The policy guide states that the term ‘‘natural’’ may be used on labeling for meat products and poultry products provided that the applicant for such labeling demonstrates that:
(1) The product does not contain any artificial flavor or flavoring, coloring ingredient, or chemical preservative (as defined in 21 CFR 101.22), or any other artificial or synthetic ingredient; and
(2) The product and its ingredients are not more than minimally processed. The USDA defines minimally processed to include food processed in a manner that does not fundamentally alter the food.
Minimal processing may include:
(a) Those traditional processes used to make food edible or to preserve it or to make it safe for human consumption, e.g., smoking, roasting, freezing, drying, and fermenting, or
(b) Those physical processes that do not fundamentally alter the raw product or that only separate a whole, intact food into component parts, e.g., grinding meat, separating eggs into albumen and yolk, and pressing fruits to produce juices.
Relatively severe processes, e.g., solvent extraction, acid hydrolysis, and chemical bleaching, would clearly be considered more than minimal processing. Thus, the Policy Memo explained, the use of a flavor or flavoring, for example, that has undergone more than minimal processing would, in general, mean that a product in which the ingredient is used could not be called ‘‘natural.’’
The Policy Memo acknowledged, however, that there are exceptions to this general view, and that the presence of an ingredient that has been more than minimally processed would not necessarily preclude a product from being promoted as ‘‘natural.’ The Policy Memo stated that exceptions of this type would be granted on a case-by-case basis if it could be demonstrated that the use of such an ingredient would not significantly change the character of the product to the point that it could no longer be considered a ‘‘natural’’ product. In such cases, the ‘‘natural’’ claim would have to be qualified to clearly and conspicuously identify the ingredient, e.g., ‘‘all natural ingredients except dextrose, modified food starch, etc.’’
Policy Memo 055 further stated that all products claiming to be ‘‘natural’’ or a ‘‘natural’’ food should be accompanied by a brief statement that explains what is meant by the term ‘‘natural,’’ i.e., that the product is a ‘‘natural’’ food because it contains no artificial ingredients and is only minimally processed. This statement should appear directly beneath or beside all ‘‘natural’’ claims or, if elsewhere on the principal display panel of the label, an asterisk should be used to tie the explanation to the claim.
According to the 1982 policy, the decision of the Agency to approve or deny the use of a ‘‘natural’’ claim may be affected by the specific context in which the claim is made. For example, claims indicating that a product is ‘‘natural’’ food, e.g., ‘‘natural’’ chili or ‘‘chili—a ‘‘natural’’ product’’ would be unacceptable for a product containing beet powder which artificially colors the finished product. However, ‘‘all natural ingredients’’ might be an acceptable claim for such a product.
The USDA also requires that the manufacturer include on the label a descriptive factor of what makes the food natural. For example, if the label for frozen meatballs says “all natural,” the label must also state “minimally processed” and “no added colors, artificial ingredients, or chemical preservatives.” Making a “natural” claim without a more detailed description is a violation of USDA guidelines.
The USDA also distinguished between food that is “natural” and food that comes from animals that are “naturally raised,” and the two terms are separate. AMS reiterated that the “Naturally Raised Marketing Claim standard” was independent of and district from the FSIS label approval policies governing use of natural claims. In a 2009 published notice, USDA defined “naturally raised” to include meat from animals that were raised with no growth hormones, no antibiotics, and no animal by-products. USDA also incorporated an exception to the no antibiotics component because antibiotics were considered important for parasite control even before an animal becomes ill. USDA would later publish a withdrawal of this notice on January 11, 2016 with an effective date of January 12, 2016. The distinction by USDA does provide a window in the thinking of USDA, namely a clear division between natural claims and naturally raised claims. This is a major reason why NPA supports the term natural to start with post-harvest and so does not include how the seed was created or how the animal was raised. Any discussions involving traditional plant breeding vs. GMOs, harvesting, animal husbandry techniques, use of growth hormones and antibiotic use for livestock would apply to “naturally raised claims” and not “natural” claims. NPA supports the position that “Organic” is non-GMO. There would be no difference between the terms “natural” and “organic” if “natural” similarly encompasses non-GMO.
NPA believes that any definition of ‘natural’ emanating from the FDA will incorporate and should draw heavily upon USDA’s definition and the regulatory guidance framework from FSIS in order to harmonize the term across all agencies. It is important to note that as of the date of these comments (May 2016); no further publications or rule-making on this subject has been published – now over nine years after the period of public comment closed.
FDA Definition of “Natural”. Many mistakenly believe that FDA’s foray into ‘natural’ started with their 1991 advisory opinion, which adopted that “natural’ means “nothing artificial or synthetic [was] added to … the product that would not normally be expected to be there.” On June 18, 1966, FDA announced a new and much stricter set of vitamin and mineral regulations in the Federal Register, which would go into effect on December 15, 1966. The proposed 1966 “Vitamin and Mineral Regs” attempted to undo the statutory requirement from Congress, which held FDA responsible to prove as false and misleading any statements about dietary foods it opposed such as “natural” claims. In effect, FDA tried to ban use of the term “natural” and other truthful statements on foods and dietary supplements.
In the June 1966 version of the regulations, FDA called for the full disclosure of sources, including natural or synthetic, on the labels of all vitamin and mineral supplements. The disclosure was meant to conform with other FDA policies theoretically aimed at insuring the consumer’s access to the kind of information needed to evaluate the merits of different brands. Between June and December of 1966, the FDA changed its mind on the label requirement for food supplements and declared that future regulations would ban all mention of dietary supplement sources, be they natural or synthetic. The proposed rule prompted the Vitamin Hearings. The FDA’s position was that vitamins from natural sources are identical to those made synthetically, and therefore a declaration of the source was unnecessary. The final Vitamin and mineral regulations were published on August 2, 1973. NPA (then NNFA) fought implementation of the regulation. The U.S. Court of Appeals ruled in favor of NPA, and Judge Friendly stated in his August 15, 1975 decision that the word “natural” could be used on labels as long as no unproven claims were made. Today the source ingredient that supplies a dietary ingredient is permitted within the meaning of 21 CFR 101.36(d) and may be identified within the nutrition label (ie. supplement facts box) or listed in an ingredient statement in accordance with 101.4(g) below the nutrition label.
FDA attempted previously to define natural when used on the labels of human food. In its preamble of a proposed rule published in the Federal Register, FDA placed only three stipulations on the term “natural” when used in food labeling.” First, FDA stated “natural” was a term used to convey that a food is composed only of substances that are not manmade and therefore somehow more wholesome. Second, FDA did not restrict use of the term “natural” except for added color, synthetic substances, and flavors under 21 CFR §101.22. Third, FDA considered “natural” to mean that nothing artificial or synthetic (including colors regardless of source) is included in, or has been added to, the product that would not normally be expected to be there. NPA agrees with FDA that the term “natural” is used on a variety of products to mean a variety of things, and it is time that the agency define the term to remove ambiguity surrounding use of the term that results in misleading claims. FDA suggested the idea to entertain a prohibition on “natural” claims entirely on the grounds that they are false or misleading; however, that was already attempted 2 decades earlier.
Issue:
FDA has held a longstanding policy for using “natural” claims in food labeling when it was first articulated in that proposed rule in November 1991. FDA states that for foods to be called “natural”, nothing artificial or synthetic (including colors regardless of source) is included in, or has been added to, the product that would not normally be expected to be there. FDA, however, has never formally defined “natural,” nor has FDA established requirements through regulation for the use of “natural” in food labeling. In recent years, FDA has received a number of citizen petitions requesting that FDA define “natural,” and has received requests from federal courts asking it to respond to questions about “natural” claims being disputed in litigation.1 On November 12, 2015, in response to these inquiries, FDA finally published a notice in the Federal Register requesting public comments and other information on use of the term “natural” in food labeling, including when, if ever, the term would be false or misleading. FDA asked specifically for comments on: use of “natural” in the labeling of foods derived from GE; whether and how consumers associate the term “natural” with the terms “organic” or “healthy”; whether use of “natural” should be allowed only in the labeling of single ingredient foods; and other issues related to processing of foods and ingredients.
Action:
NPA supports the following:
- Organic is Non-GMO
- FDA Should Address and Define “Natural” Through the Public Rulemaking Process
- Current FDA Policy Contradicts Vermont State Law on “Natural”
- NPA Supports a National Natural Labeling Standard for All Foods Including Dietary Supplements to Avoid a Patchwork of Regulations from States on “Natural” Claims
- NPA Requests FDA to Incorporate Its Policies on Foods Developed from Biotechnology in its Definition of Natural
- NPA Requests FDA to Harmonize Its Definition of ‘Natural’ with the Same Term Defined by USDA’s FSIS
- NPA Requests the FDA to Amend the FFDCA and Sections of the Codified Regulations to Allow the Term “Natural” on Foods Derived from Biotechnology
- Minimally Processed—NPA Supports the Development of an Illustrative List of “Natural” Processes
- NPA Requests that Natural Preservatives, Natural Colors, Incidental Additives and Some Processing Aids Be Included in the Development of a Positive Illustrative List of Natural Ingredients
- NPA Supports a Multi-Tier Approach on “Natural” Claims, akin to USDA’s Organic Program, to Recognize Companies Who Only Use Natural Ingredients and Encourage Other Companies to Switch from Synthetic to Natural Alternatives
