In our post about the nutraceuticals industry, dietary supplements as a category of nutraceuticals are subject to compliance with FDA regulations under the Dietary Supplement Health and Education Act of 1994 (DSHEA). But you should also bear in mind that FDA does not have the authority to review dietary supplement products for safety and effectiveness before they are marketed. The onus is on the manufacturer and distributors to ensure that the products are not adulterated or misbranded. As you already know, vitamins, minerals, herbs, amino acids, enzymes and any combinations thereof are the ingredients of a dietary supplement product. These products are taken orally and the product label has to explicitly state that it is a “Dietary Supplement” which is its statement of identity. The word “dietary” may be replaced with a description of the type (ex: herbal supplement) or names of one or more ingredients (ex: bee pollen supplement) Let us first understand the timelines of how regulations concerning dietary supplements came to be in the United States.
Dietary supplements are not to be marketed as drugs and manufacturers are not allowed to make disease claims such as “lowers high cholesterol” or “treats heart disease.” Let me walk you through a recent example where FDA issued a warning letter to a company this year. Without naming the company and the products, it is pertinent to note that the FDA has refused to accept the products as “Dietary Supplements” as marketed by the company because the products are marketed as “…intended for use in the cure, mitigation, treatment, or prevention of disease.” Note: The claims on the product labeling explicitly mentions the name of a disease. So under section 201(g)(1)(B) of the Act, 21 U.S.C. § 321(g)(1)(B), these products are classified as unapproved new drugs. So the above example illustrates the importance of what is printed on the label of a dietary supplement. Let us analyze the label requirements. As is the practice, information about the product is given in the Principal Display Panel (PDP) as well as the Information Panel which is on the right of the PDP. The information required to be present on the PDP are: Statement of Identity and the Net Quantity of Contents statement. The same has to be replicated on all alternate PDPs present, if applicable. The Information Panel should contain: “Supplement Facts” panel, the Ingredient List, and the Name and Place of Business of the manufacturer, packer, or distributor if such information does not appear on the PDP.
Thus far we have covered the regulations in the US pertaining to dietary supplements. How are these products regulated in other geographies, for instance, Europe? • “According to the EU General Food Law Regulation (EC) No 178/2002, food supplements are considered as foodstuffs. Responsibility for the safety of these products lies with the food business operator placing the product on the market. The reference EU legislation in the area of food supplements is Directive 2002/46/EC, which establishes harmonized lists of the vitamins and minerals substances used in the manufacture of food supplements and the labelling requirements for these products. EFSA provides scientific opinions to support the evaluations carried out by the European Commission.” • What are the key labelling requirements according to the Directive 2002/46/EC? • The names of the categories of nutrients or substances that characterise the product or an indication of the nature of those nutrients or substances; • The portion of the product recommended for daily consumption; • A warning not to exceed the stated recommended daily dose; • A statement to the effect that food supplements should not be used as a substitute for a varied diet; • A statement to the effect that the products should be stored out of the reach of young children. • Note: In addition, presentation and advertising must not attribute to food supplements the property of preventing, treating or curing a human disease, or refer to such properties.
What are the equivalent Indian Regulations for dietary/food supplements? • Under Section 92 of the Food Safety and Standards Act, 2006 (34 of 2006), the Food Safety and Standards • Authority of India (FSSAI) has framed the Food Safety and Standards (Health Supplements, Nutraceuticals, Foods for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016. • Every package of health supplement or nutraceuticals shall carry the following information on the label, namely: • The words “Health Supplement” or “Nutraceutical” • Common name of the health supplement, or a description sufficient to indicate the true nature of the health supplement including the common names of the categories of nutrients or substances that characterize the product • A declaration as to the amount of the nutrients or substances with a nutritional or physiological effect present in the product • An advisory warning “NOT FOR MEDICINAL USE” prominently written • The quantity of nutrients, where applicable expressed in terms of percentage of the relevant recommended daily allowances as specified by the Indian Council of Medical Research and bear a warning, “Not to exceed the recommended daily usage”
For nutraceuticals, advisory warning in cases where a danger may exist with excess consumption and another advisory warning for “recommended usage” • A statement that the health supplement is not be used as a substitute for a varied diet • A warning or any other precautions to be taken while consuming, known side effects, if any, contraindications, and published product or drug interactions, as applicable and • A statement that the product is required to be stored out of reach of children. • Note: No food business operator shall use additives for health supplement formulation except those specified in Schedule VA/VE/VF of these regulations. Nutraceuticals shall contain any of the ingredients specified in Schedule I through VIII. • With this we come to the end of the blog series on regulations pertaining to nutraceuticals and dietary/food/health supplements across the globe.