a&r’s News Digest – This month on the broken Deadlock on Medical Device Legislation Rule 21; EFSA has rejected yet another claim; a&r scouting on novel packaging and products; and insight on consumer acceptance of insect food.



Powdered formulations delivered by an air-based nutrition system

Aero Designs is introducing Aerolife, a system of small, inhaler-like packages that can even be refilled. The company states that its system is like a customized “app” for every need in a consumer’s day. Tiny quantities of food and nutrients in a variety of combinations tailored to various nutritional needs are drawn into the mouth, carried by the air travelling through the device.

a&r comments: In a time when most dietary supplements are still tablets and soft-gel capsules, this innovation breathes new life into the category, demonstrating that there is yet room for novel ideas. This packaging design is reminiscent of an asthma inhaler, giving the product a medicinal look that sets it apart from more conventional food supplement packaging designs.


South Korean ice cream against hangovers

Gyeondyo (“hang in there”) contains the fruit flavonoid dihydromyricetine derived from the Oriental raisin tree Hovenia dulcis. This natural herbal remedy has been used since the 17th century in Korea as a treatment for nausea. The product, a slightly grapefruity glacé, is available from the supermarket chain With me FS.

a&r comments: This is not the only hangover remedy on the South Korean market by far. However, the delivery format certainly is a novel and appealing one. The question is whether having such a tasty way of doing away with hangovers might exacerbate alcoholism.


Medical Devices – Deadlock on Rule 21 broken

On May 25, at the 10th Trialogue, a final agreement was reached on the long-awaited Medical Device legislation. A “risk-based approach” has been applied, with the result that substance-based medical devices will be in Class III, the highest risk class, if they achieve their intended purpose in the stomach or lower intestinal tract. Also, nasal sprays and other devices whose intended purpose is achieved in the nasal or oral cavities will now be put in Class IIa. The new Medical Device legislation is expected to come into force in January 2020.

a&r comments: This means that all substance-based medical devices for topical or nasal application will be considered Class IIa, while products with an intended purpose in the stomach or lower gastrointestinal tract become class III, if they or their metabolites, are systematically absorbed. For all the others, which have only a physical interaction within the GI-tract will be considered class IIb. Class I is no longer accessible to substance-based medical devices. Manufacturers of these products would be faced with considerable work and expenses for additional data on efficacy and quality when launching these products if this version of the new legislation came into force.

EFSA has rejected a health claim on DHA and memory function

The health claim application, submitted by DSM Nutritional Products, was rejected due to very conflicting data, with the majority of submitted studies not showing any effect. Only two submitted studies show a beneficial effect of DHA supplementation on memory function.

a&r comments: This health claim rejection demonstrates the importance of submitting health claim applications only when the majority of submitted clinical trials have a positive outcome when substantiating the claimed effect.


Insect food: Consumer acceptance found in Germany

A recent survey commissioned by the Germany Federal Institute of Risk Assessment (BfR) on the perception of insects as a food source revealed that the majority of Germans are not averse to the concept. Especially educated urban males aged 18 – 30 stated their openness. Males are in all twice as open to eating insects as females, as are people interested in the environmental impact of food choices.

a&r comments: The advantages of this food source are obvious: a high level of sustainability compared to mammalian sources, a food high in protein and nutrients, and a history of safe use that can be proven from other cultures. This general openness by German consumers indicates that other EU countries might follow. However, regulations would probably require some level of Novel Food authorization.

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Your experts

Irene Wohlfahrt
Irene WohlfahrtSenior Consultant
Dr. Inês Rocha
Dr. Inês RochaScientific Consultant

At analyze & realize, we are experts in the field of natural health products, having provided our services for more than 20 years. We offer a unique combination of expertise in natural health products through our scientific, regulatory, and strategic innovation consulting and our clinical research organization with its own clinical trial center in Berlin, Germany. Thanks to our close interaction with the natural product market as well as our extensive network, we are always at the forefront of the latest information and innovation trends. With its international team of 35 employees, a&r is a leading European one-stop-shop ready to guide and support your needs in natural health product innovation.

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