International Regulations on Dietary Supplements: Challenges and Opportunities

April 1, 2016 - 27 minutes read

An aging population has increasingly become a global phenomenon, not just in developed countries, but also among emerging regions.1 The shift to an elderly population adds to healthcare burdens, but also creates opportunities for functional food and dietary supplement producers. As consumers nowadays are increasingly concerned about how to improve their quality of life, instead of simply satisfying their basic health needs, the market for supplements that meet consumer demands for enhanced nutrition and wellness has boomed over the last several decades and is projected to show continuing growth.2 This article explains how dietary supplements are regulated differently worldwide, with a focus on challenges and opportunities in various countries.

United States: Opening new office for dietary supplements and tightening rules

In the United States, both the end product and ingredients of dietary supplements are regulated by the Food and Drug Administration (FDA), under the Dietary Supplement Health and Education Act (DSHEA) 1994. New ingredients (post 1994) to be added into dietary supplements need to go through the New Dietary Ingredient Notification (NDIN) process.3

Dietary supplements include products such as vitamins and minerals, “botanical” or herbal products, amino acids and enzyme supplements. Albeit having requirements on labels[1] and product safety[2], FDA relies more on post-market surveillance for dietary supplements, unless the product contains non GRAS (Generally Recognized as Safe) substances or new ingredients.4 FDA generally begins regulation after supplement products enter the market.5

There are three categories of claims for dietary supplements in the U.S.: (1) nutrient content claims with terms such as “high”, “free” and “reduced” indicating the level of key nutrients; (2) structure/function claims (SFC) describing the effect of a dietary supplement on the structure and function of body; (3) health claims (HC), which needs approval from FDA describing a relationship between an ingredient and a disease or health-related condition. The main difference between a SFC and a HC is that a SFC cannot imply any effects of the dietary ingredient on disease or condition.4

Facing growing regulatory needs from the dietary supplement industry that has more than quadrupled in the last two decades, FDA announced in December 2015 the creation of the new Office of Dietary Supplement Programs (ODSP), previously a division under Office of Nutrition Labeling and Dietary Supplements. The formation of the new office signals FDA’s increased attention onto dietary supplements. Moreover, FDA issued more than seven warning letters and six recalls during the two months prior to the announcement, demonstrating its tightened regulations on this rapidly expanding industry.6

China: Significant changes made on health food regulation system

In China, dietary supplements are regulated as “Health Foods”, together with functional foods. In April 2015, the new Chinese Food Safety Law was officially passed, and went into effect on October 1, 2015. Thirteen items of this law are related to health food regulation.7 On July 28, 2015, the China Food and Drug Administration (CFDA) released three new drafts about health food regulatory system changes, covering the registration and notification process, creation of a claim catalog and an ingredient catalog for health food, and labeling. Built upon the existing registration procedure, a new notification system was added into the regulatory scheme, allowing authoritative responsibilities to be released from CFDA to provincial FDAs overseeing domestic products, and covering first-time imported goods that are recognized nutrition supplements, like vitamins and minerals.8 Previously, it was a time-consuming and expensive process to get each foreign health food product registered under the “blue hat”[3] registration system. Now, it is possible to save time and costs for manufacturers and bypass the “blue hat” registration, instead going through the notification process with qualified products.7

The newly added function catalog and ingredient catalog for dietary supplements expand the scope of CFDA’s regulations, enabling CFDA to more comprehensively oversee not only the end product but also ingredients.8 A database will be built and updated. The new guidance also requires more detailed and comprehensive R&D[4] reports from health food manufacturers, showing that the government now more focuses on product safety and scientific evidence of functionality.9 After such an ingredient catalog is established, producers with ingredients accepted in food but not allowed in dietary supplements yet will be encouraged to apply for their ingredients to be added to the catalog rather than taking the lengthy and costly “blue hat” route.10

Japan: New opportunities arise for health food manufacturers

In Japan, dietary supplements are regulated as “Food with Health Claims”, under two categories: (1) “Food with Nutrient Function Claims” (FNFC) for vitamins and minerals; (2) “Food for Specified Health Uses” (FOSHU) for other functions. However, there are also products on the market in the form of capsules or tablets, which are not defined by the law in Japan. 11

Qualified dietary supplements approved by the Consumer Affairs Agency are allowed to be marketed as FOSHU, with a formal logo and claims on the product label indicating its dietary uses for promoting health. In addition, other forms of health food or functional food that meet FOSHU requirements can also be marketed as a FOSHU. However, due to the complexity of the FOSHU approval–the lengthy process and expensive investment in providing evidence on products’ effects and safety (clinical trials are usually required)–the number of newly approved FOSHU experienced a sharp decline in the recent years. 12

To reverse this trend and revitalize the domestic health food market, as well as potentially reduce health care costs in the long run, Japan’s Prime Minister Shinzo Abe has included the initiative of accelerating “functional food” sales as a key component of growth strategy under Abenomics[5]. In April 2015, a new labeling category, “Food with Functional Claims (FFC)” that includes a simplified approval process and less rigorous requirements than FOSHU products, was introduced to potentially boost Japan’s health food market. This particularly brings opportunities for small and mid-sized companies, because no government approval is required for this category, and lower regulatory bars means shortened approval process and reduced costs for scientific evidence verification.13

Furthermore, the Japanese government lowered the threshold for minimum nutritive value of FNFC products, allowing more products, even with a lower content of certain vitamin and mineral or other accepted nutrients (such as n-3 fatty acids), to be qualified for the claim. The main incentive of these revisions and new FFC category is to encourage domestic, smaller companies and farmers to more easily and effectively market their products. On the other hand, it also gives foreign manufacturers an opportunity to test the waters before risking their investment and time, maybe unnecessarily, in getting FOSHU approval.14

Europe: Updated novel food regulation possibly opens up opportunities

In Europe, food supplements that provide concentrated sources of nutrients or other substances with a nutritional or physiological effect are regulated by the European Commission (EC). EC has labeling requirements, a harmonized[6] list for vitamins and minerals allowed to be added into food supplements and a harmonized list for their permitted sources. EC also sets up both maximum and minimum amounts of vitamins and minerals in supplements. For substances other than vitamins and minerals, EC conducts a study and provides a report to describe the legislative and regulatory landscape in Europe as a community and in different countries that may apply to the product, with no harmonized approach on the regulation of these substances.15 EC also has rules on two kinds of claims pertinent to dietary supplement regulation: nutrition claims, indicating the content and level of certain nutrient ingredients, and health claims that link a nutrient to a health condition. 16

Permitted vitamin and mineral ingredients on the EC positive list are mostly in inorganic form, which has been regarded as too restrictive by manufacturers who want to get approval for their product, where ingredients are often in organic form that are not present on the list. Although manufacturers can apply to add their ingredient to the list, the process is usually lengthy and costly, scrutinized strictly and frequently rejected by the European Food Safety Agency (EFSA).17 In June last year, three years after the case was filed, the UK Health Food Manufacturers’ Association (HFMA) and the Natuur-en Gezondheidsproducten Nederland (Dutch NPN) lost in a court case against EC to annul their current regulation on health claims. The two trade groups urged for an integrative approach, especially for botanical health claims, instead of the current step by step processing of claims, alleging that the current health claim regulation is “overly prohibitive and restrictive”. 18

Though EC and EFSA are still protecting their conservative stance on dietary supplement regulation and claims, as reflected by this court case, a recent new regulation does signal some opportunities opening up for industry. Last year, a new EU regulation on Novel Foods was adopted in November and published in December, and scheduled to go into effect in January 2018. This update essentially expands the definition of Novel Food to include food from clones, engineered nanomaterial, and traditional food demonstrated as safely consumed for at least 25 years in third countries[7].19 The new rule shortens the application process of a novel food from three years to 18 months on average, and grants generic authorizations that any manufacturer can place their product onto market once the product type is approved as Novel Food. 20

Australia/New Zealand: Routines and regulatory scheme overhaul

Dietary supplements are also referred to as “complementary medicines” in Australia, many of which, including herbal, vitamin, mineral and nutritional supplements,21 fall under the scope of Therapeutic Goods Act 1989 (TGA). According to a health survey by the Australian Bureau of Statistics, in 2011-2012, about one third of Australians surveyed reported to take at least one dietary supplement on the day before the interview. A higher proportion was reported in females than males, and in older age groups than younger groups. 22

TGA also covers medicine; medicinal products that fall under TGA are regulated at federal level, while foods, including those with health claims, are predominantly regulated at state level by territory regulatory bodies. Since there is sometimes an overlap between food and medicine, the Australian government provides a Food-Medicine Interface Guidance Tool to help manufacturers determine whether their products need to conform to TGA rules. If determined as therapeutic goods, the product needs to be listed in the Australian Register of Therapeutic Goods (ARTG) in addition to being approved by TGA.23 When applying for a listing in the ARTG, the product needs to be certified to meet criteria for ingredients, dosage, evidence, indication, side effects, etc. 21

In New Zealand, complementary medicines have been regulated by Dietary Supplements Regulations 1985 under the Food Act of 1981 until this year, when the Natural Health Product Bill comes into effect and supersedes the Dietary Supplements Regulations of 1985. Under the new regulatory scheme, natural product manufacturers need to notify the authority by registering their products onto an electronic database and provide evidence in the form of a report for any health claims on the product.24 Additionally, all supplement products can only contain ingredients from a large list permitted by the authority.25

Canada: Authoritative oversight and similarities with other countries

In Canada, dietary supplements are called natural health products (NHPs), which is a subcategory under drugs regulated by Natural Health Products Regulations (NHPR).26 A survey in 2010 by Ipsos-Reid shows that 73% Canadians regularly take NHPs including vitamins, minerals, herbal products and homeopathic medicines. Besides post-market monitoring, Health Canada assesses all NHPs before they are allowed to the market, and audits the product manufacturing process. 27

NHPs must have a product license to be legally sold in Canada. Manufacturers need to provide information about the ingredients, source, dose, potency and recommended use(s) to Health Canada to get the license. Once approved, they will receive an eight digit number that must appear on the label to notify consumers that the product has been approved by Health Canada. There are products on the market still waiting for the full evaluation by HC. 28 To be still legally sold, these products, often lower risk ones, can bear an Exemption Number (EN)[8] on the label showing that they only went through initial assessment but no full evaluation from HC. HC no longer issues EN after February 2013, but more shifting to the NHP licensing process.29 NHPs also need to comply with specific requirements on labeling and adverse reaction reporting, respectively.28

Similar to Australia, Health Canada provides guidance for manufacturers to help them determine with which regulations their products must comply. For most food-like NHP products, the definition of the product fits into the food category and therefore needs to be regulated as food. Similar to the EU, Canada has a category for novel foods, in which it is clearly stated that novel foods include genetically modified (GM) foods; however, in the E.U., whether certain GM foods meet their newly updated novel food definition is still uncertain. Similar to the U.S., Canada allows nutrient content claims. Health Canada has the following categories of claims: (1) Quantitative declaration of nutrients and non-nutrients; (2) Composition and quality claims; (3) Nutrient function claims; (4) Health claims, which contains general health claims, function claims, disease risk reduction claims and therapeutic claims and; (5) Probiotic claims.26

Worldwide, countries have been setting up new rules and regulations for dietary supplements to boost domestic economy, to attract foreign investments and imports, or to set a bar and protect their local industry. Some countries share certain similarities but are vastly different in their approach. Manufacturers need to navigate a narrow pathway in this ever-changing regulatory landscape to ensure that they do not on one hand, fail to comply with local regulations, but on the other hand do not miss any opportunities in certain regions.

 

[1] Dietary supplement labeling is regulated under Nutrition Labeling and Education Act (NLEA) enacted in 1990.4

[2] Not authorized to check the safety and labeling of dietary supplement, FDA is responsible to take post-market action against any adulterated or misbranded product.4

[3] Only after registration, the official label of health food with a “blue hat” image is allowed to be displayed onto product in China. Otherwise, it is not considered as a recognized health food by the government.

[4] According to the current guidance, the R&D report should include the health needs analysis of the target population, analysis and review about the functionality of ingredients and efficacy on human health, mechanism and theoretical basis of experiments on the functionality of product, appropriate dosage and use range, and other relevant R&D information.

[5] Abenomics refers to the economic policies advocated by Shinzo Abe since elected to his second term as Prime Minister of Japan in December 2012.

[6] EC has harmonized rules and regulations, between Europe Union member states, on products in Directive 2002/46/EC, mainly for vitamins and minerals and their sources.

[7] Novel Food is defined as food that has not been consumed to a significant degree by humans in the EU prior to 1997, when the first Regulation on novel food came into force. ‘Novel Food’ can be newly developed, innovative food or food produced using new technologies and production processes as well as food traditionally eaten outside of the EU. Examples of Novel Food include agriculture products from third countries (chia seeds), newly produced nutrients (synthetic zeaxanthin) or extracts from existing food (rapeseed protein).30

[8] Exemption Numbers (EN) issuance were only used during 2010-2013 as a temporary transition measure for companies to wait for the approval of their products from HC. As the NHP licensing procedure became more efficient and less time consuming since 2013, HC stopped issuing ENs after that, but have been licensing all the products that are qualified.29

 

References

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