A group of Swedish researchers choose the U.S. to launch a functional and innovative drink-carbonated, but sugar-free-that can reduce glycemic response. #GoodIdea!
We return to surprise ourselves with good news, confirming that it is always possible to contribute to the public good (even in the beverage industry). It also causes us to reflect, why is it so difficult to innovate in Europe?
‘Good Idea‘, history and goals
‘Good Idea’
– or rather, Excellent Idea (!) – is the second, brilliant initiative of brothers Bjorn and Rickard Öste. The first was ‘Oatly.’, a natural oat-based beverage alternative to milk, developed in the early 1990s. (1) On the initiative of Rickard Öste-a renowned professor and scientist in food chemistry-who organized a multidisciplinary team of researchers at Lund University (Sweden) for this purpose.
‘Oatly’
, the natural oat drink, enabled the Swedish brothers to break out of the Scandinavian market and land first in England, then in the U.S. and China. Vibrant markets capable of appreciating an innovation of real value to public health. In fact, oats, like barley, are rich in soluble fiber, among which betaglucans stand out, which help control blood cholesterol. As well as to reduce, within a meal, the postprandial blood glucose rise. (2)
Addressing ‘diabesity‘ -i.e., theglobal epidemic of obesity and diabetes-through the development and provision of functional foods that can contribute to its prevention is the focus of #GoodIdea. The Öste brothers’ second venture, which in turn stems from a project carried out with the ‘Anti Diabetic Food Center‘ at Lund University. And he has in fact enlisted as chief scientific officer one of his associate professors, Mrs. Elin Östman.
‘Good Idea’, the functional drink
The first ‘Good Idea’ is to help the metabolism manage the glycemic spike that follows the consumption of meals rich in simple carbohydrates (e.g., sugars). Previous research from Lund University had associated whey intake-before and during a meal rich in simple carbohydrates-with an appreciable increase in insulin production. With a consequent, significant reduction in the relatively high glycemic response. This effect was later observed with other dietary proteins as well.
Subsequent studies have identified the five essential amino acids whose intake-before and during a meal-is found to stimulate insulin production and reduce peak glycemic levels (in addition to other valuable functions). The researchers thus achieved an alchemy of these amino acids with a small amount of chromium, itself known to play a favorable role in glycemic regulation.
The functional drink developed through this research is a water with added carbon dioxide, flavorings and the ‘6-pack.’ Which in this case does not mean the ‘abdominal six-pack,’ as in the jargon, but rather the combination of the 5 essential amino acids with chromium. (3) The efficacy of the drink in controlling glycemic response was evaluated in a series of double-blind versus placebo studies. With results converging on reduced peak glycemic after a meal rich in simple carbohydrates, -25% on average, compared with placebo. (4)
Health claims, the European context
Chromium-naturally contained in several foods, including legumes and cocoa-is a mineral salt with which several human health benefits are associated. Regulation (EU) no. 432/12, in providing an exhaustive list of the only health claims authorized in the European Union, reports two benefits associated with the intake of this mineral:
– ‘contributes to normal macronutrient metabolism’,
– ‘contributes to the maintenance of normal blood glucose levels.’ (5)
Both of the above-mentioned claims can only be used on foods that contain at least a ‘significant amount‘ of trivalent chromium. That is, an amount equal to 15 percent of the so-called Reference Nutritive Value (NRV) per 100 g of solid food (or 100 ml in the case of products other than beverages, e.g., condiments, or per serving in single-serving products), and 7.5 percent of the NRV for beverages. (6)
Since the VNR related to chromium is 40 μg/day, the claim nutritional ‘source of chromium‘ may be used in the labeling and advertising of a beverage provided it contains 3 μg of chromium in 100 ml. (7) And upon fulfillment of this condition, either or both of the health claims associated with chromium, as stated above, may be expressed.
If, on the other hand, additional concepts are to be expressed-in particular, that relating to the reduction (and the extent of the reduction) of peak glycemic levels following a meal-in Europe, an application for prior authorization of the appropriate health claim must be submitted. (8) Which inevitably results in a delay of at least one yearto the launch of the product in the market(time to market).
The European regulatory environment continues to be a major obstacle to innovation in the food sector. With regard to health claims, as well as other cases of functional foods and ingredients. (9) The costs associated with the procedures and the uncertainties about their outcomes–related to both scientific assessments (by Efsa, European Food Safety Authority), both under political scrutiny by the European Commission (and member states) – are also a barrier to entry for SMEs and startup innovative, already plagued by systematic difficulties in accessing credit.
Health claims, the situation in the U.S.
Good Idea® Functional Sparkling Waters have been registered in the United States as a dietary supplement, with the claim ‘May help those with normal blood sugar levels manage spiked sugar after a meal.’ The drink’s label, on the company website, features a disruptive claim, ‘Cut yoursugarspikes, dump the post-mealslump‘ (literally, ‘cut your glycemic spikes, dump the post-meal slump‘).
‘Its blend of five amino acids and chromium has been scientifically shown to reduce peak blood sugar after a meal, on average, by 25 percent. To put it simply, amino acids prepare the metabolism to take better care of carbohydrates, while the small amount of chromium further refines the process and reduces sugar cravings. The effect has been confirmed by independent studies in Sweden, Germany, Canada and the United States (Orlando, FL).’
The operator points out that the Food & Drug Administration (FDA, USA) has not yet evaluated the above health claims in detail, and that in any case the supplement does not aspire to prevent or treat or cite diseases. The major difference in the regulatory environment is that in the U.S.-based on the scientific evidence already made available to the authorities-the company can submit its innovation right away, on its own responsibility. Without having to wait a year or face additional costs of bureaucracy and uncertainty.
The overseas legislator’s approach , it should be noted, is not only business-friendly but is primarily people-friendly. Since it is the U.S. population itself-where today an estimated 86 million individuals are in a pre-diabetic condition, and obesity prevalence is predicted to be close to 50 percent by 2030 (10)-that can benefit immediately from a product that can be ‘part of the solution’ to the diabesity in place. (11)
#GoodIdea!
Dario Dongo
Notes
(1) Oatly’s ‘history and philosophy,’ at https://www.oatly.com/int/the-oatly-way
(2) See reg. EU 432/12, Annex
(3) SEE www.goodideadrinks.com
(4) The scientific bibliography supporting the project is summarized and listed on the company’s website at https://goodideadrinks.com/wp-content/uploads/SciRevJanuari2018.pdf
(5) See reg. EU 432/12, as amended, ‘concerning the establishment of a list of permitted health claims on foods, other than those referring to the reduction of disease risk and to children’s development and health‘
(6) See reg. EU 1169/11, Annex XIII, point 2
(7) See reg. EU 1169/11, Annex XIII, item 1
(8) Pursuant to reg. EC 1924/06, Article 15. The excessive onerousness of the procedure is confirmed by the paucity of dossiers submitted and finalized in recent years. To the point that the last update of the list of authorized health claims in the EU was on 22.8.17 (!)
(9) On the subject of health claims, note the continuing European uncertainty over the regulation of botanicals (see https://www.greatitalianfoodtrade .it/integratori/ingredienti-botanici-claims-e-produzione). About functional ingredients, we mention the equally uncertain and topical cases of coloring foods and plant extracts with preservative functions (see https://www.greatitalianfoodtrade .it/consum-attori/estratti-vegetali-nelle-carni-cortocircuito-in-europa)
(10) See note 9 to the previous article https://www.greatitalianfoodtrade.it/consum-attori/coca-cola-falsa-propaganda-su-salute-e-benessere-rivolta-ai-teenager-studio-scientifico
(11) See also footnotes 4 and 5 to the article https://www.greatitalianfoodtrade.it/idee/acido-oleico-e-prevenzione-malattie-coronariche-via-libera-in-usa for more information on the current rules in the US and EU regarding health claims.
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
