Regulations: Updating Organic -- July 2007
In
the Federal Register, 72 F.R. 27252-27264, the Agricultural Marketing Service
proposed amendments to the National List of Allowed and Prohibited Substances.
The proposal updates the list of non-organic ingredients that may be used in
processed foods labeled as organic*.
The proposal was mandated in part by the requirement that processed foods containing non-organically produced ingredients be allowed to be labeled as “organic” so long as the ingredients are 1) unavailable in an organic form; and 2) listed on the national list (the list which the proposal updates.)
The proposal is that the National List be updated to include: casings, from processed intestines; celery powder; chia (Salvia hispanica); colors derived from agricultural products—annatto extract, beet juice, beta carotene derived from carrots, black currant juice, black/purple carrot juice, blueberry juice, carrot juice, cherry juice, chokeberry-aronia juice, elderberry juice, grape juice, grape skin extract, paprika, pumpkin juice, purple potato juice, red cabbage extract, red radish extract, saffron and turmeric; dillweed oil; fish oil—stabilized with organic ingredients or only with ingredients on the national list, §§ 205.605 and 205.606; fructo-oligosaccharides; galangal, frozen; gelatin; hops; inulin-oligofructose enriched; konjac flour; lemongrass-frozen; orange shellac-unbleached; peppers (chipotle chile); starches—rice starch, unmodified—for use in organic handling until May 22, 2009, and sweet potato starch; Turkish bay leaves; Wakame seaweed (Undaria pinnatifida); and whey protein concentrate.
FDA has released the “Preliminary Topline Frequency Report” of its Experimental Study of Health Claims on Food Packages. The report is the result of a project begun in November 2003 to study consumers’ understanding of front-panel “health” messages, including specific disease-related health claims, structure-function claims, dietary guidance and nutrient content claims. Consumers’ understanding of claims which do not mention the nutrient which underlies the benefit of the claim was singled out for evaluation—i.e., “yogurt may reduce the risk of osteoporosis,” as compared to “calcium-rich foods, such as yogurt, may reduce the risk of osteoporosis.”
Some 18 front panels were investigated: yogurt/calcium/osteoporosis, orange juice/potassium/high blood pressure, and pasta/lysoton (a fictitious nutrient)/heart disease on the horizontal axis, and claims of food-specific health claims, substance-specific health claims, nutrient content claim, structure-function claim, dietary guidance, and “no message” on the vertical axis.
The report includes six categories of “selected preliminary findings.” Many of the findings relate specifically to consumers’ awareness of the three foods shown; however, among the more general findings are the following:
1. When consumers are already generally aware of a health benefit (i.e., calcium and osteoporosis), consumers perceive the same benefit whether it is expressed as a health claim, a structure-function claim, a dietary guidance claim or a nutrient-content claim. This preliminary finding is particularly significant at a minimum of three levels for FDA as it explores the evolution of regulatory guidance: is there a value to the amount of research, study and scientific agreement required by FDA to support a health claim (significant scientific agreement) versus that required for a nutrient content claim (% of DV)? Secondly, if “good” or “excellent” convey the same net takeaway as lengthy health claims, does the additional language create unnecessary confusion as to the message; and, thirdly, if consumers are reading past the limitations of the claim, is there a potential for consumer injury? (Finding 5.b.)
2. The format of the claim (health claim, structure-function claim, dietary guidance) does not affect the likelihood of the consumer recognizing the presence of the nutrient in the food. (Finding 2.c.)
3. When there is a widespread understanding of the benefit of a nutrient, the nature of the claim (health claim, structure-function claim, dietary guidance) does not affect whether consumers will recognize the presence of the nutrient in other foods. (Finding 4.a.)
4. A nutrient health claim is the best motivator to purchase. (Finding 6.a.)
The purpose of the study is to “enhance(s) FDA’s understanding of consumer responses to health claims and informs any policy initiatives(s) that FDA may undertake in the future.”
*“Organic foods” must contain at least 95% organic ingredients.
The proposal was mandated in part by the requirement that processed foods containing non-organically produced ingredients be allowed to be labeled as “organic” so long as the ingredients are 1) unavailable in an organic form; and 2) listed on the national list (the list which the proposal updates.)
The proposal is that the National List be updated to include: casings, from processed intestines; celery powder; chia (Salvia hispanica); colors derived from agricultural products—annatto extract, beet juice, beta carotene derived from carrots, black currant juice, black/purple carrot juice, blueberry juice, carrot juice, cherry juice, chokeberry-aronia juice, elderberry juice, grape juice, grape skin extract, paprika, pumpkin juice, purple potato juice, red cabbage extract, red radish extract, saffron and turmeric; dillweed oil; fish oil—stabilized with organic ingredients or only with ingredients on the national list, §§ 205.605 and 205.606; fructo-oligosaccharides; galangal, frozen; gelatin; hops; inulin-oligofructose enriched; konjac flour; lemongrass-frozen; orange shellac-unbleached; peppers (chipotle chile); starches—rice starch, unmodified—for use in organic handling until May 22, 2009, and sweet potato starch; Turkish bay leaves; Wakame seaweed (Undaria pinnatifida); and whey protein concentrate.
FDA has released the “Preliminary Topline Frequency Report” of its Experimental Study of Health Claims on Food Packages. The report is the result of a project begun in November 2003 to study consumers’ understanding of front-panel “health” messages, including specific disease-related health claims, structure-function claims, dietary guidance and nutrient content claims. Consumers’ understanding of claims which do not mention the nutrient which underlies the benefit of the claim was singled out for evaluation—i.e., “yogurt may reduce the risk of osteoporosis,” as compared to “calcium-rich foods, such as yogurt, may reduce the risk of osteoporosis.”
Some 18 front panels were investigated: yogurt/calcium/osteoporosis, orange juice/potassium/high blood pressure, and pasta/lysoton (a fictitious nutrient)/heart disease on the horizontal axis, and claims of food-specific health claims, substance-specific health claims, nutrient content claim, structure-function claim, dietary guidance, and “no message” on the vertical axis.
The report includes six categories of “selected preliminary findings.” Many of the findings relate specifically to consumers’ awareness of the three foods shown; however, among the more general findings are the following:
1. When consumers are already generally aware of a health benefit (i.e., calcium and osteoporosis), consumers perceive the same benefit whether it is expressed as a health claim, a structure-function claim, a dietary guidance claim or a nutrient-content claim. This preliminary finding is particularly significant at a minimum of three levels for FDA as it explores the evolution of regulatory guidance: is there a value to the amount of research, study and scientific agreement required by FDA to support a health claim (significant scientific agreement) versus that required for a nutrient content claim (% of DV)? Secondly, if “good” or “excellent” convey the same net takeaway as lengthy health claims, does the additional language create unnecessary confusion as to the message; and, thirdly, if consumers are reading past the limitations of the claim, is there a potential for consumer injury? (Finding 5.b.)
2. The format of the claim (health claim, structure-function claim, dietary guidance) does not affect the likelihood of the consumer recognizing the presence of the nutrient in the food. (Finding 2.c.)
3. When there is a widespread understanding of the benefit of a nutrient, the nature of the claim (health claim, structure-function claim, dietary guidance) does not affect whether consumers will recognize the presence of the nutrient in other foods. (Finding 4.a.)
4. A nutrient health claim is the best motivator to purchase. (Finding 6.a.)
The purpose of the study is to “enhance(s) FDA’s understanding of consumer responses to health claims and informs any policy initiatives(s) that FDA may undertake in the future.”
*“Organic foods” must contain at least 95% organic ingredients.
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