Here’s the situation: You have a dietary supplement product, or better yet, an idea for a product, and you want the world to experience its greatness! Is this possible? Can your product be sold around the globe in its current form? Is your supplement a “one-size-fits all” formulation across international markets? We can help. Our clients frequently come to us for a formulation compliance check across multiple international markets.
Before entering into any international market, you need to make sure that your product can be legally sold there. A “one-size-fits-all” formulation is desired, but sometimes requires a bit of work.
A “one-size-fits-all” formulation is desired, but sometimes requires a bit of work.
Having differing formulations in different markets can be quite costly, so the opportunity to create a formulation compliant in several countries lowers production costs. For example, the “one a day” multivitamin products you see on the shelves are gaining popularity in North America because this is what many international consumers want – and so the higher demand markets are reformulating products we see domestically.
It should also be noted that having a compliant formulation is a separate but related issue to having a compliant label. A single formulation, in theory, can be compliant across multiple international markets, but having one label for many different markets is not as simple (or achievable). In fact, an “international label” is usually not possible unless the label is stripped of virtually anything helpful to the consumer. (For example, in Canada at least one health claim is required for a supplement label in Canada, whereas health claims are not permitted in the EU, except for a few on nutrients.) But our focus in this blog article is creating multi-compliant formulations, as follows.
Product classification is the first important step. In most countries, what we call “natural health products” in Canada are treated as “food supplements” in other markets. This can often pose a challenge for supplements, as an ingredient that may be considered a supplement in one country could otherwise be classified as a “medicine” or “prescription drug” in another. Once we determine its classification, we can then start to work on screening the formulation to determine where you can sell your product as is, or suggest formulation tweaks that may broaden your market prospects.
For example, some countries have specific source material requirements for vitamins and minerals; others have upper limits on ingredient amounts; and some countries have restrictions (or bans) on certain ingredients altogether. A common example here includes Vitamin B12, with methylcobalamin not permitted as source in Australia or China, but allowed in the EU and Canada. Upper limits of Vitamin B12 also vary widely, with a dosage of 1000 mcg/day pre-cleared in Canada, whereas China has an upper limit of only 10 mcg/day. We have helped clients with formulation screens for many markets, including the EU, Australia, China and Japan, providing formulation advice as well as noting possible health claims that they could pursue in these markets.
Other areas to consider when developing a “worldwide” formulation are the continuing regulatory responsibilities in these markets and the associated costs that go along with them. Product testing is one such requirement for many markets and can be a costly burden. Having a Finished Product Specification test that complies with the requirements of all desired markets can greatly reduce the financial costs associated with lab testing. Often the simple approach is to take the most stringent test (per nutrient or formulation) among all the desired markets, making this the standard.
At NHP Consulting, we can develop a finished product testing specification that can meet the requirements of multiple markets, thus eliminating the need to test the product separately for each individual country. The upfront consulting fees are significantly lower than the long-term testing fees if each market is tested separately.
The upfront consulting fees are significantly lower than the long-term testing fees if each market is tested separately.
Also, by carefully choosing the most stringent requirements and selecting pharmacopoeial methods recognized in all markets, passing results in one country will equate to passing results in all. Another area to mention here is stability, with some countries requiring stability data at the time of product registration. Carefully creating a stability protocol is a great way to ensure that the stability data you gather on your formulation will suffice for each market you want to enter. For example, if one potential market includes the Middle East, your stability protocol should account for the higher temperatures experienced here, with additional time point testing to justify a shelf life in different climate zones.
NHP Consulting has expertise in formulation review, stability protocols and finished product specification development in many markets and offers consulting services in this area to help our clients save money and ensure compliance with country-specific regulations. Contact us to discuss specific products that we can help you register or create compliant formulations/product testing sheets.