Labeling Dietary Supplements (1)

1
Labeling Dietary Supplements
2
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.
3
(No Transcript)
4
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.
5

• 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.

6

• 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

7

• 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.