{"id":4140,"date":"2024-02-14T10:49:59","date_gmt":"2024-02-14T15:49:59","guid":{"rendered":"https:\/\/journals.law.unc.edu\/firstamendmentlawreview\/?p=4140"},"modified":"2024-09-27T18:57:21","modified_gmt":"2024-09-27T18:57:21","slug":"low-fodmap-labeling-fda-usda-and-unconstitutional-censorship","status":"publish","type":"post","link":"https:\/\/journals.law.unc.edu\/firstamendmentlawreview\/low-fodmap-labeling-fda-usda-and-unconstitutional-censorship\/","title":{"rendered":"Low-FODMAP Labeling: FDA, USDA, and Unconstitutional Censorship"},"content":{"rendered":"\n<p>By: <a href=\"https:\/\/www.linkedin.com\/in\/alexandriabelton\/\">Alexandria Belton<\/a>, Vol. 22 Staff Writer<\/p>\n\n\n\n<p class=\"has-medium-font-size\"><strong>An Indigestible Blow to First Amendment Protection<\/strong><\/p>\n\n\n\n<p><strong>The Food and Drug Administration (FDA)<\/strong> and <strong>United States Department of Agriculture (USDA) <\/strong>are attempting to unconstitutionally censor \u201cnon-misleading factual\u201d labeling of foods <strong>low in \u201cfermentable oligosaccharides, disaccharides, monosaccharides and polyols\u201d <\/strong><a href=\"https:\/\/www.hopkinsmedicine.org\/health\/wellness-and-prevention\/fodmap-diet-what-you-need-to-know#:~:text=What%20is%20FODMAP%3F,digestive%20distress%20after%20eating%20them.\"><strong>(low-FODMAP)<\/strong><\/a>. So why is this important, it\u2019s just food labeling, right? Wrong. FODMAP foods are related to an intolerance to \u201ccarbohydrates\u201d or <a href=\"\/med.virginia.edu\/ginutrition\/wp-content\/uploads\/sites\/199\/2018\/05\/Low_FODMAP_Diet_12.16.pdf\">\u201csugar\u201d<\/a> contained in certain foods. Ingesting these sugars induces gastrointestinal inflammation; digestive disorders such as Irritable Bowel Syndrome (IBS) become triggered, leading to <a href=\"\/\/efaidnbmnnnibpcajpcglclefindmkaj\/\">\u201cabdominal discomfort, distention, bloating, fullness, nausea, and or pain.\u201d\u00ad\u00ad\u00ad\u00ad<\/a><\/p>\n\n\n\n<p>Speakers are entitled to communicate lawful information, including labeling that promotes verified \u201clow-FODMAP\u201d foods. Thus, food labels asserting as low-FODMAP are deserving of First Amendment protection. Food consumers are entitled to access <a href=\"https:\/\/esha.com\/blog\/food-product-labeling-and-packaging-101\/#:~:text=milk%2C%20and%20sesame.-,Name%20and%20Address%20of%20the%20manufacturer%2C%20packer%2C%20or%20distributor,and%20the%20full%20street%20address.\">non-misleading factual food labels that include:<\/a><\/p>\n\n\n\n<ul>\n<li>Allergan Declaration \u2013 major food allergens (milk, egg, fish, tree nuts, wheat, peanuts, soybeans, sesame, crustacean, shellfish)&nbsp;<\/li>\n\n\n\n<li>Ingredient Statement \u2013 food ingredients<\/li>\n\n\n\n<li>Nutrition Facts \u00ad\u2013 serving size, mandatory nutrients (sugars, fat, sodium, etc.)<\/li>\n\n\n\n<li>Statement of Identity \u2013 legal or common name of the food<\/li>\n\n\n\n<li>Net Quantity of Contents \u2013 the amount of food in a package<\/li>\n<\/ul>\n\n\n\n<p class=\"has-medium-font-size\"><strong>So, what&#8217;s all the grumble about?<\/strong><\/p>\n\n\n\n<p>The FDA and USDA are venturing beyond the permitted bounds of commercial speech restriction.&nbsp; <em>Przybocki v. US Department of Agriculture <\/em>is a pending federal First Amendment lawsuit against the USDA and FDA. <a href=\"https:\/\/ij.org\/press-release\/customer-small-business-owner-sue-usda-and-fda-over-policy-that-outlaws-truthfully-labeling-food-as-easy-to-digest\/\">Gourmend Foods founder, Ketan Vakil<\/a> is attempting to challenge the FDA\u2019s and USDA\u2019s ban on Low-FODMAP labeling by arguing that Gourmend\u2019s labeling is (1) \u201cfactual and non-misleading\u201d, (2) supported by extensive lab testing, and (3) has received low-FODMAP certification. The FDA and USDA oversee label approval thus all labels must be preapproved prior to their use.<\/p>\n\n\n\n<p>&nbsp;<a href=\"https:\/\/www.fda.gov\/food\/food-labeling-nutrition\/label-claims-conventional-foods-and-dietary-supplements\"><strong>The Nutrition Labeling and Education Act of 1990 (NLEA)<\/strong><\/a> authorizes label claims that typifies foods based on nutrient content. However, labels classified as \u201cnutrient content claims\u201d are subject to regulations and restrictions enforced by the FDA; therein lies the problem. Gourmend\u2019s LOW-FODMAP labeling is inconsistent with the FDA\u2019s preapproved \u201cnutrient content claims\u201d thus the USDA refuses to grant its approval.<\/p>\n\n\n\n<p class=\"has-medium-font-size\"><strong>An Appetite for Protection: <em>Central Hudson<\/em><\/strong><\/p>\n\n\n\n<p>Speech consistent with a commercial transaction is considered <a href=\"https:\/\/www.google.com\/search?q=1A+website+commerical+speech&amp;rlz=1C5CHFA_enUS918US918&amp;oq=1A+website+commerical+speech+&amp;gs_lcrp=EgZjaHJvbWUyBggAEEUYOTIJCAEQIRgKGKABMgkIAhAhGAoYoAEyCQgDECEYChigAdIBCDgxMzRqMGo3qAIAsAIA&amp;sourceid=chrome&amp;ie=UTF-8\">\u201ccommercial speech.\u201d<\/a> Food labeling such as \u201clow-FODMAP\u201d supplies information to consumers to facilitate informed buying. <a href=\"https:\/\/supreme.justia.com\/cases\/federal\/us\/447\/557\/\"><em>Central Hudson Gas &amp; Electric. v. Public Service Commission,<\/em><\/a><em> <\/em>establishes a four-part test for determining if commercial speech is protected and the extent of constitutional protection. The <a href=\"\/labelsunwrapped.org\/wp-content\/uploads\/2021\/06\/First-Amendment-Food-Labeling-Issue-r5.pdf\"><em>Central Hudson Test<\/em><\/a> applies <a>intermediate scrutiny<\/a><a href=\"#_msocom_1\">[AY1]<\/a>&nbsp; (laws are constitutional only if they <a href=\"\/crsreports.congress.gov\/product\/pdf\/IF\/IF12308\">directly advance a substantial government interest<\/a> and are not broader than necessary to serve that interest); the constitutionality of the government\u2019s regulation depends on all four factors being met. The four factors are:<\/p>\n\n\n\n<ol>\n<li><strong>Whether the speech is protected:<\/strong> speech must be non-misleading and relate to lawful activity.<\/li>\n\n\n\n<li><strong>Whether the government has a substantial interest in controlling the speech:<\/strong> the regulation must directly concern and advance the government\u2019s \u201csubstantial interest\u201d (protection of public health, safety, and welfare).<\/li>\n\n\n\n<li><strong>Whether the regulation advances the substantial government interest:<\/strong> the regulation must directly aid in the government achieving their interest (regulation advances protection of public health, safety, and welfare).<\/li>\n\n\n\n<li><strong>Whether the government\u2019s regulation is necessary to serve that substantial interest:<\/strong> regulation must be narrowly tailored (written precisely, least restrictive) to advance the government\u2019s interest. If a less restrictive means exists, the regulation is not narrowly tailored.<\/li>\n<\/ol>\n\n\n\n<p class=\"has-medium-font-size\"><strong>Applying <em>Central Hudson<\/em> to Low-FODMAP Labeling Censorship<\/strong><\/p>\n\n\n\n<p>First, Gourmend\u2019s labeling is \u201cfactual and non-misleading\u201d thus overcoming the initial question of \u201cDoes this speech warrant First Amendment Protection?\u201d Second, the government must show that they have a substantial interest in regulating low-FODMAP labeling; <a href=\"\/labelsunwrapped.org\/wp-content\/uploads\/2021\/06\/First-Amendment-Food-Labeling-Issue-r5.pdf\">substantial interest is a pressing reason (protects public health, safety, and welfare)<\/a> and not merely a hypothetical assertion. Protection of public health, safety, and welfare may be a legitimate objective. However, if Gourmend\u2019s labeling is \u201cfactual and non-misleading\u201d, what then necessitates public protection?<\/p>\n\n\n\n<p>Third, censoring certified low-FODMAP labeling does little to advance public health. &nbsp;<a href=\"https:\/\/law.justia.com\/cases\/federal\/district-courts\/FSupp2\/14\/10\/2519323\/\">In <em>Pearson v. Shalala,<\/em> the court held,<\/a> &nbsp;that the FDA unconstitutionally restricted labeling on dietary supplements. The labels produced by a supplement manufacturer contained statements asserting unsubstantiated health claims. &nbsp;The FDA failed to advance a substantial government interest; label censorship was not the best means to address unfounded health claims. Finally, the FDA\u2019s censorship of Gourmend\u2019s products is likely unnecessary to serve \u201ca substantial interest.\u201d Meaning, the FDA must show that their means (label censorship) reasonably achieve their end: consumer protection (public safety, health, and welfare).<\/p>\n\n\n\n<p>Similarly, to <em>Pearson,<\/em> in <a href=\"https:\/\/ij.org\/case\/fda-skim-milk\/\"><em>South Mountain Creamery v. FDA<\/em> the FDA\u2019s censorship<\/a> of \u201cskim milk\u201d failed to pass constitutional muster. A creamery owner labeled their product \u201cskim milk.\u201d Unsurprisingly, the FDA found the label of \u201cskim milk\u201d (purely labeled as skim milk) inconsistent with their labeling of \u201cskim milk\u201d (the label included skim milk and additional additives). The owner&#8217;s First Amendment right was upheld, and the FDA was subsequently blocked from enforcing unconstitutional censorship.<\/p>\n\n\n\n<p class=\"has-medium-font-size\"><strong>Conclusion: A Need for Transparency<\/strong><\/p>\n\n\n\n<p>The <em>Central Hudson <\/em>Test provides the means by which the FDA and USDA may limit food labeling. However, low-FODMAP labeling infringes on Gourmend\u2019s right to freedom of speech. Gourmend Foods wishes to promote consumer awareness and consumers wish to receive the truth. Perhaps, a spoonful of transparency is just what the doctor ordered. First Amendment protection proves to be a digestible remedy after all.&nbsp;<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\" \/>\n\n\n\n<p><a id=\"_msocom_1\"><\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>By: Alexandria Belton, Vol. 22 Staff Writer An Indigestible Blow to First Amendment Protection The Food and Drug Administration (FDA) and United States Department of Agriculture (USDA) are attempting to unconstitutionally censor \u201cnon-misleading factual\u201d labeling of foods low in \u201cfermentable oligosaccharides, disaccharides, monosaccharides and polyols\u201d (low-FODMAP). So why is this important, it\u2019s just food labeling, <a href=\"https:\/\/journals.law.unc.edu\/firstamendmentlawreview\/low-fodmap-labeling-fda-usda-and-unconstitutional-censorship\/\" class=\"more-link\">&#8230;<\/a><\/p>\n","protected":false},"author":10,"featured_media":4141,"comment_status":"open","ping_status":"open","sticky":true,"template":"","format":"standard","meta":[],"categories":[396,11],"tags":[52,68,124,133,140,141,152,157,177,203,218,247,362],"_links":{"self":[{"href":"https:\/\/journals.law.unc.edu\/firstamendmentlawreview\/wp-json\/wp\/v2\/posts\/4140"}],"collection":[{"href":"https:\/\/journals.law.unc.edu\/firstamendmentlawreview\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/journals.law.unc.edu\/firstamendmentlawreview\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/journals.law.unc.edu\/firstamendmentlawreview\/wp-json\/wp\/v2\/users\/10"}],"replies":[{"embeddable":true,"href":"https:\/\/journals.law.unc.edu\/firstamendmentlawreview\/wp-json\/wp\/v2\/comments?post=4140"}],"version-history":[{"count":1,"href":"https:\/\/journals.law.unc.edu\/firstamendmentlawreview\/wp-json\/wp\/v2\/posts\/4140\/revisions"}],"predecessor-version":[{"id":5264,"href":"https:\/\/journals.law.unc.edu\/firstamendmentlawreview\/wp-json\/wp\/v2\/posts\/4140\/revisions\/5264"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/journals.law.unc.edu\/firstamendmentlawreview\/wp-json\/wp\/v2\/media\/4141"}],"wp:attachment":[{"href":"https:\/\/journals.law.unc.edu\/firstamendmentlawreview\/wp-json\/wp\/v2\/media?parent=4140"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/journals.law.unc.edu\/firstamendmentlawreview\/wp-json\/wp\/v2\/categories?post=4140"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/journals.law.unc.edu\/firstamendmentlawreview\/wp-json\/wp\/v2\/tags?post=4140"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}