Scrutinising the term ‘nutraceutical’ - a global regulatory perspective

Tincy Varghese and P. Mishal, Fish Nutrition, Biochemistry and Physiology Division of the Central Institute of Fisheries Education in Mumbai call for a uniform global nomenclature to reduce consumer confusion

The nutraceutical market is driven by new trends in popular healthcare, such as the shift towards preventive therapies and self-medication, an increase in disposable income, etc. However, nutraceuticals have different legal definitions according to various state laws.

This disparity often confuses customers regarding the original use, potency and safety of the product. Thus, there is an absolute need for a uniform nomenclature for this booming nutraceutical market across the globe. Nutraceuticals are not regulated in the same way that drugs are. Instead, they are classified according to different food categories. This is a notable benefit for animal and fish farmers, as they can use cheaper nutraceuticals in appreciable amounts to prevent diseases, which is also beneficial for drug companies.

Along with the knowledge that nutrition has a role in preventing many diseases, the use and trade of nutraceuticals has boomed in recent years, across the entire globe. As the population ages, there is a marked increase in healthcare spending, especially in developed countries. Thus, the growth in health- and wellness-related retail chains and a favourable pricing environment has also boosted the growing nutraceuticals market. The regulation of these products is one of the boldest challenges for any government as the people get ever more health conscious.

As nutraceuticals blur the line between food and drugs, it is often difficult — by legal definition — to distinguish between nutrients, food additives, drugs and nutraceuticals

In turn, nutraceuticals are proving to be more and more popular with consumers as they offer a safe and easy healthcare option. As such, this requires careful formulation and the implementation of government legislation. As nutraceuticals blur the line between food and drugs, it is often difficult — by legal definition — to distinguish between nutrients, food additives, drugs and nutraceuticals. When their dosages exceed those of a normal diet, the bioactivity of a nutrient can be drug-like. For instance, at the levels present in foodstuffs, tryptophan is a nutrient; but at higher doses, its activity can be drug-like. It is the precursor of serotonin, which is extensively used to treat insomnia.1

Legal definitions by region

Legal definitions are predominantly based on two aspects: one is the origin or source; the other is the benefit(s) that it can provide to the consumer. The nomenclature of nutraceuticals also varies in different countries: the US describes them as “Dietary Supplements,” in Canada they’re referred to as “Natural Health Products” and Japan lists them as “Foods for Special Health Use (FOSHU)”. These definitions can be general or specific; there are distinct definitions and regulations for dietary supplements and functional foods in the US, Canada and Europe, whereas in Japan, both dietary supplements and functional foods are governed under the same set of regulations.

The US and Canada list the attributes that a product must have to be called a nutraceutical, whereas Europe and Japan just provide general guidelines on the properties that a product should have to be named as such. Traditional and herbal medicines are included in the definition of dietary/nutritional supplements in Canada. Japan does not mention traditional herbal medicines under FOSHU but the US includes herbs and botanicals in its definition. The Indian definition (as per the Food Safety and Security Act 2006) specifies the ingredients that a product should have — and the general properties of nutraceuticals derived from traditional medicines have been excluded from the definition.

US regulations

The US Food and Drug Administration (FDA) regulates foods, additives, drugs and cosmetics. Unlike pharmaceutical drugs and foods, nutraceuticals do not fall under the remit of FDA; they are monitored as “dietary supplements” according to the Dietary Supplement, Health and Education Act (DSHEA) of 1994.2 The DSHEA removed the authority of the FDA to regulate so-called “dietary supplements” and considers them to be a “separate regulatory category of food”. They neither come under the category of food nor drug.

DSHEA defines a dietary supplement as “a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: vitamins, minerals, amino acids, herbs or other botanicals; a concentrate, metabolite, constituent, extract or combination of the ingredients listed above”. Furthermore, it must also conform to the following criteria:

  • be intended for ingestion in pill, capsule, tablet, powder or liquid form
  • not be represented for use as a conventional food or as sole item of a meal/diet
  • be labelled as a “dietary supplement”

Dietary supplements versus drugs

As per FDA’s definition, a drug is an article intended to diagnose, cure, mitigate, treat or prevent disease. Yet, both dietary supplements and drugs are intended to affect the structure and function of the body. To use a new food additive or a drug, the manufacturer must conduct safety studies and must submit the results to FDA for review and premarket approval. This is not the case for dietary supplements as they are legally in a class that can be marketed without satisfying FDA’s safety criteria. Thus, dietary supplements need no premarket testing and/or approval.

The DSHEA states that the manufacturer is responsible for the safety evaluation of the product. If the dietary supplement contains a new ingredient, the manufacturer must inform FDA that the new ingredient “can reasonably be expected to be safe” within 75 days of going to market. As per DSHEA, “safe” means no significant risk of illness. This notice must provide information that supports the manufacturer’s conclusion that the ingredient is safe.

This is a less rigorous process than that required for food additives (articles used to enhance the aroma, colour, structure or taste of a food), for which there is a formal safety evaluation process. FDA has to prove that the dietary supplement is unsafe once it’s marketed. FDA has only ever found one dietary supplement to be unsafe, which is the weight loss/energy supplement Ephedra.

Dietary supplements versus foods: Foods are not intended to affect the structure and function of the body, whereas dietary supplements are. Additionally, dietary supplements are only supposed to supplement the diet, and not be used as a conventional food or as the sole item of a meal or diet.

Adulteration under DSHEA: A dietary supplement is adulterated if it or an ingredient in it presents a “significant or unreasonable risk of illness or injury” when used as directed. If the dietary supplement contains a new ingredient, a disclaimer should be given on the product as follows: “There is insufficient information to provide assurance that the ingredient does not present any significant or unreasonable risk of illness or injury”.

Labelling and claims: According to DSHEA, a dietary supplement label must include the following:

  • name of each ingredient
  • quantity of each ingredient
  • total weight of all ingredients, if a blend
  • identity of the plant part used
  • the term “Dietary Supplement”
  • nutritional labelling information (calories, fat, sodium)

The DSHEA does not require approved therapeutic claims to be listed, unlike drugs. Moreover, dietary supplements aren’t supposed to be taken alone as a substitute for any food or medicine. The Act must be amended to restore some FDA authority to regulate nutraceuticals as it gives little consideration for the safety of consumers. Most marketed “nutraceuticals” have no evidence of efficacy and a few are harmful, but they may divert patients away from proven and legitimate therapies.3

European Union (EU) regulations

In EU food law, a regulatory framework for ‘functional foods’ or ‘nutraceuticals’ does not exist. The rules are numerous and depend on the nature of the foodstuff. The rules of the General Food Law Regulation, including responsibility for food safety, traceability, recall and notification, are applicable to all foods. If a claim was made that implies a medicinal benefit for a nutraceutical product, the product will need to comply with the regulatory requirements for medicinal products, in respect of safety, efficacy, quality testing and marketing authorisation procedures.

According to EU regulations, claims regarding the beneficial effects of nutraceuticals can only be “health claims” and not “medicinal claims”. For instance, claims must not state that by eating/taking the nutraceutical, a disease will be prevented or cured, only that it may help to improve health, possibly assisting in the avoidance of the onset of illness.

The regulatory frameworks of PARNUTS (foods prepared for particular nutritional purposes) or dietetic foods and of food supplements may be applicable to some ‘functional foods’. The Novel Food Regulation applies to ‘functional foods’ that are ‘new’. More precisely, nutraceuticals are regulated as “food supplements” according to Directive 2002/46/EC of the European Parliament and Council of 2002 on the approximation of the laws of Member States relating to food supplements.4 This establishes harmonised rules for the labelling of food supplements and introduces specific rules for vitamins and minerals in food supplements. The regulations are governed by the European Food Safety Authority (EFSA).

Regulations in India

As with other countries, Indian legislation doesn’t actually assign any specific legal status to nutraceuticals. Government of India regulations for nutraceuticals in the market include the Food Safety and Standards Act (FSSA), which was passed in 2006, and is yet to be implemented.5 It includes eight laws enforced by the state commissioner of food safety. According to FSSA, “foods for special dietary use” are specially processed or formulated to satisfy particular dietary requirements, which exist because of a particular physical or physiological condition or specific diseases and disorders. These foodstuffs are presented such that their composition must differ significantly from the Indian Standard (IS) composition of ordinary foods of comparable nature, and may contain one or more of the following ingredients:

  • plants or botanicals or their parts in the form of powder, concentrate or extract in water, ethyl alcohol or hydroalcoholic extract, single or combination
  • minerals or vitamins or proteins or metals or their compounds or amino acids in amounts not exceeding the Recommended Daily Allowance for Indians or enzymes (within permissible limits)
  • substances from animal origin
  • dietary substances for use by humans that supplement the diet by increasing total dietary intake

Chapter 4, Article 22 of FSSA addresses nutraceuticals: a nutraceutical doesn’t include any drug and it can only be used for oral administration. They can be used as conventional foods, which cannot claim to cure any specific disease, but can claim indirect health benefits such as “contains calcium.” The disease reduction claims are not permitted in Asia, as Asian countries have not taken up the codes of practice defined by Codex Alimentarius.

Regulations in Canada

In Canadian regulations, nutraceuticals come under the category known as “Natural Health Products,” as per “The Natural Health Product Regulations” introduced in 2004 by Health Canada.6 The law is governed by the Food and Drugs Authority of Canada. The definition covers the following products:

  • vitamins and minerals
  • herbal remedies
  • homeopathic medicines
  • traditional Chinese medicines
  • probiotics
  • other products, such as amino acids and fatty acids

Regulations in Japan

Japan is the pioneer nation in the area of regulating functional foods/nutraceuticals. The concept of Foods for Specified Health Use (FOSHU) was established in 1991.7 Foods identified as FOSHU must be approved by the Ministry of Health and Welfare after the submission of comprehensive science-based evidence to support the claim for the foods when they are consumed as part of an ordinary diet. As per the FOSHU Act, functional food can have three functions:

  • nutrition
  • sensory satisfaction
  • physiological improvements

Regulations in Australia

In Australia, medicinal products/foods are referred to as ‘complementary medicines’ and are regulated as medicines under the Therapeutics Goods Act, 1989, which was implemented in 1991.8 The law is governed by the Department of Health and Ageing and the definition covers herbal medicines, vitamins and minerals, nutritional supplements, homoeopathic medicines, aromatherapy products and traditional medicines.

Regulations in Russia

According to the Russian Ministry of Healthcare and Social Development’s order number 1898, dated 15 April 1997 and titled “Concerning the Procedure for the Examination and Health Certification of Active Dietary Supplements,” nutraceuticals are regulated under the term Biologically Active Dietary Supplements (BADS).9 The definition covers nutraceuticals (vitamins, minerals, amino acids, dietary fibres) and parapharmaceuticals (bioflavonoid, alkaloids, essential oils, polysaccharides). As per the rule, BADS are “foodstuffs with clinically proven effectiveness.” They are recommended prophylactically and for the prevention of pharmaceutical therapy induced side-effects and the achievement of complete remission. The focus in Russia is based more on preventive medicine for chronic disease rather than as part of a person’s daily health food diet.

The disadvantages

The legal definitions for nutraceuticals/functional foods are somewhat dissimilar in different countries. For example, in Japan, functional foods are defined according to their use of natural ingredients. In the US, however, functional foods can include ingredients that are products of biotechnology. In India, functional foods can include herbal extracts, spices, fruits and nutritionally improved foods or food products with added functional ingredients.

The requirements to make therapeutic claims are unrealistic — herbals are not patentable

Another drawback is that the requirements to make therapeutic claims are unrealistic — herbals are not patentable and, as there is no provision to patent, the chance of capital investment by companies is reduced. Even if some companies are ready to do efficacy testing and studies, it may take a long time compared with drugs. There is no provision to offer financial protection to the innovator companies who are ready for this long-term challenge. Moreover, the dietary supplement label is inappropriate for nutraceuticals. Huge problems such as quality control and unethical and criminal elements exist in the industry.

The benefits

Less-strict regulations offer advantages to both drug companies and animal farmers; drug companies are always eager to capitalise on quick financial returns. In this respect, nutraceuticals offer significant advantages compared with the long development times and high manufacturing cost of drugs. Moreover, nutraceuticals don’t (yet) require costly clinical trials. As with any intensive farming system, appropriate medication is needed to manage livestock populations during large-scale farming. However, disease prevention strategies such as vaccinations and the extensive use of drugs are limited in large-scale culture owing to regulatory constraints. Nutraceuticals can help here as they are not actually regulated for use in culture systems. In addition, the efficacy testing of nutraceuticals requires less time for farmed species compared with testing in humans.

Regulations, market and consumers

As nutraceuticals blur the line between food and drugs, it is often difficult — by legal definition — to distinguish between nutrients, food additives, drugs and nutraceuticals

Latency exists in the market because regulatory frameworks are not yet implemented and the resources to implement regulation are inadequate. As nutraceuticals blur the line between food and drugs, it is often difficult — by legal definition — to distinguish between nutrients, food additives, drugs and nutraceuticals. Moreover, nutraceuticals often command high prices and can lack credibility. While discussing gaps in the regulatory framework, one of the major issues will be consumer safety: the consumer has to spot the label, claims made on the label, nutritional and ingredient information and, most importantly, the instructions for use. Consumers often check out the price first, believing that the higher the price, the better the quality.

Conclusion

Regulation presents significant challenges to the globalisation of nutraceuticals in many ways. Mainly, the regulatory variation between countries hinders global trade and marketing. For instance, most of the countries discussed take a relaxed approach to regulation, yet China’s process for dietary supplement approval involves a strict testing protocol, in line with the US process for pharmaceutical approval. Unlike DSHEA, the regulations of some nations don’t seem to provide adequate distinction between food, drug and nutraceuticals.

Also, unfortunately, nutraceuticals sometimes find themselves in the same regulatory category as common foods: standardisation of dose and method of delivery to improve efficacy and health benefits could overcome this. Thus, there is an explicit need to study nutraceutical dose-related issues. It is essential to test and regulate the use of nutraceuticals in a cost-effective and efficient manner with regard to farm animals. This can offer a better health, not only to those cultured animals, but to human beings who consume them.

References

1. S.H. Zeisel, “Regulation of Nutraceuticals,” Science 5435, 1853–1855 (1999).

2. F.H.E. Degnan, “Federal Regulation of Dietary Supplements: Eight Years After the Enactment of DSHEA, Where Are We?” JANA 6, 11–22 (2003).

3. C.V. Taylor, “Regulatory Frameworks for Functional Foods and Dietary Supplements,” Nutr. Rev. 62(2), 55–59 (2004).

4. P. Coppens, M.F. de Silva and S. Pettman, “European Regulations on Nutraceuticals, Dietary Supplements and Functional Foods: A Framework Based on Safety,” Toxicology 221, 9–74 (2006).

5. Food Safety and Security Act of India: www.drugscontrol.org/food%20safety%20and%20standards%20Act%2006.pdf (2006).

6. Health Canada – Natural Health Products Directorate website: www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php#a2.

7. K. Yamada, et al., “Health Claim Evidence Requirements in Japan,” J. Nutr. 138, 1192–1198 (2008).

8. Department of Health and Ageing, Therapeutic Goods Administration, Australia website: www.tga.gov.au/industry/cm-basics.htm.

9. The Russian Federation Chamber of commerce and Industry website: http://old.tpprf.ru/en/

For more information

Tincy Varghese and P. Mishal
Fish Nutrition, Biochemistry and Physiology Division, Central Institute of Fisheries Education
Versova, Mumbai
India 400061
tincymfsc@gmail.com
T +91 222 636 5198

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