For U.S. manufacturers wishing to bring their products to the EU markets, a number of strategic decisions should be made up front. Are there one or more EU countries that are more suitable than others? Which product category will be the best fit for the product? Do ingredients conform to regulatory requirements for that category? Which is the best sales channel? Does cost of goods match the expected sales in that channel?

In order to make those decisions, manufacturers should be informed about various possibilities.

Regulatory Considerations
As for regulatory product categories, the main decision is whether the product should be a food or drug product. Food products include, for example, functional foods, dietary supplements and foods for special medicinal purposes (FSMPs), while drug products include conventional medicinal products as well as traditional herbal medicinal products (THMPs). Additional considerations include the cosmeceutical and medical device categories.

Each of these categories is governed by a specific set of regulations that may preclude the use of certain ingredients, which—to make matters somewhat complicated—may also be regulated differently from member state to member state. Some of these laws are food laws concerning basic safety, hygiene, additives and labeling regulations (mandatory information, allergens, origin, etc.).

In addition, specific regulations are in place regarding the use of health and nutrition claims, the marketability of foods that have not been consumed before 1997 (novel food), or foods manufactured to satisfy the particular nutritional requirements of specific groups of people (PARNUT). For THMPs, regulation requires proof of traditional use of the herbal drug.

Once the product category has been decided, it is time to look at the product label, which has to be adapted to European requirements, and to country-specific requirements, if any.

A product label consists of mandatory information that has to be displayed in a specific format, in terms of placement and font size. If health claims are used, in text form or image form, they must be approved for the ingredients used.

Most member states require product authorization or registration, or in the case of dietary supplements, at least notification with the relevant authorities.

Channels to Explore
The next decision to be made concerns the sales channel. The pharmacy, considered the premium level, sells prescription drugs behind the counter, OTC drugs, medical foods and premium dietary supplements. This channel comes with pharmacist advice for consumers and thus offers the opportunity for consumer education.

The drugstore mainly sells personal care products, but is also a channel for dietary supplements, OTC drugs and medical devices targeted at self-medicating, informed consumers. The products sold here generally command a lower price than those sold in a pharmacy. Also, for these products, label claims and other information is crucial, since there generally is no consumer advice by sales personnel in drugstores.

Organic food stores are suitable outlets for functional foods/beverages and also for dietary supplements for self-medication. These outlets are associated with healthy living for many consumers. Products sold here may also be sold for somewhat higher prices than those in general food stores, which may also carry dietary supplements. Again, label information is of great importance for products sold via this channel.

Of growing importance is the Internet pharmacy. This is a sales channel for all kinds of health products. Consumers expect lower prices from this channel than from pharmacies. Label information usually is supplemented by further details are not listed on the label, which is one of the main advantages of the Internet sales channel. The same is true for sports nutrition products that are probably best sold via Internet nutrition shops. These may also carry dietary supplements and meal replacement products.

If a given product is targeted at a specific demographic, care should be taken to make sure this group uses the intended sales channel. For example, products targeted at the elderly should probably not be sold via Internet pharmacies, since this is a channel that is still predominantly used by teens and adults up to their 40s. Consumers in some EU countries like France, according to a recent survey, even look at this channel with continued suspicion.

Successful Case Studies
Looking at products that were successfully brought into the European marketplace, Ocean Spray’s cranberry product line is one story that should be mentioned. Ocean Spray’s cranberry juice has been marketed in the U.S. since the 1930s. The products, sold in Europe since the 1990s in groceries, organic shops, drugstores and restaurants, enjoy a growing awareness among consumers and may even carry a permitted health claim in France.

Centrum vitamins and minerals from the U.S. company Pfizer have been on the European market for a long time. Currently, eight products are available on the German market. Sold in pharmacies, they are continuously adapted to consumers’ wishes, which probably contributes to their steady success.

Another success story is one that rides the wave of wellness and organic—currently big trends in Europe. Yogi teas are herbal teas that made their market entry via special organic shops and have meanwhile spread into grocery stores.

On the food ingredient side, Phaselite is a glycoprotein complex derived from white beans that was launched in the EU as an oral medical device and has since found its way into a number of products.

These examples show that entering the EU markets is indeed possible for importers who know what they are doing. To help with that, experienced consultancies such as analyze & realize stand ready to assist.

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Joerg Gruenwald
analyze & realize ag

Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100, Fax: +49-30-40008500; E-mail: [email protected]; Website: www.analyze-realize.com.