Comments on India FSSAI health claims regulations
Subject: Draft Notification on Food Safety and Standards (Advertising and Claims) Amendment Regulations, 2021 related to revision in respect of criteria, applicability and content claims Regulations, 2021
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Relevant
section in the draft notification on which comments are being provided |
Comments/suggestion |
Rationale |
Remarks |
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Regulation 5(3)/Schedule I Nutrient Claims |
Unhealthy foods, especially those
high in fat, sugar, or salt, should not be allowed to use a nutrient claim,
even if they contain another nutrient at a level sufficient to qualify for a
nutrient claim. If a product contains an excessive
amount of a problematic nutrient (e.g., sodium, saturated fat, or
added sugar), then promotion of other nutrient qualities (e.g.,
calcium or Vitamin D, or low total fat) should be prohibited. The best solution is to condition
nutrient claims in Schedule I on the food’s overall compliance with a
comprehensive and quantitative nutrient profile model. For example, foods
might only qualify for a nutrient claim if: 1.
No more than 10% of energy of the finished product derives from
saturated fat; and 2.
The content of sodium in the finished product is less than 1 mg per kcal;
and 3.
No more than 10% of energy of the finished product derives from sugars.
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This approach would be more
consistent with Regulation10(6) of the Food Safety and Standards
(Advertising and Claims) Regulations, 2018, , which provides that no health claims shall be made for foods
that contain nutrients or constituents in quantities that increase the risk
of disease or an adverse health-related condition. A nutrient profile model
sets consistent evidence-based thresholds for those nutrients that are known to
increase risk of diseases when consumed in excessive quantities. The approach also better aligns with
Regulation 8(2), which provides that foods described as part of a
healthy/balanced diet shall not be based on selective consideration of one or
more aspects of the food and shall also satisfy the criteria for other major
nutrients. Use of health claims, including nutrient claims, should not be
based on a single nutrient, but should consider the overall effect of the
food, especially other major nutrients, on human health. Furthermore, this approach supports
the general principle of these regulations, Regulation 4(13), which states
that: “No advertisement shall be made for food products which is deceptive to
the consumers.” Nutrient claims, such as “Low in,” “Free from”, are a form of
advertisement and marketing, as they encourage health-conscious consumers to
make purchases based on purported healthiness. Consumer reliance on such
nutrient claims can be misused by the food industry to mislead or deceive
consumers into believing a product is healthy because it contains or does not
contain a specific nutrient, even though the overall nutritional composition
of the food is contrary to a healthy diet. |
Ideally, the referenced nutrient
profile model would use the same thresholds as those used in a mandatory
front-of-pack labeling system, which we understand FSSAI is currently developing. To limit the use of inappropriate
nutrient claims, the Food authority may either select an established nutrient
profile model (such as the one developed by WHO SEARO) or develop one for this
purpose specifically. The entire nutrient profile model and/or its nutrient
thresholds could be incorporated into this section of the amended
regulations. Alternatively, in absence of
nutrient thresholds, these regulations could cite the future standard without
incorporating the thresholds directly. While this approach may delay the
implementation of the nutrient claims provision, it would have the advantage
of providing consistent thresholds across related policies. |
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Schedule I(6) Trans Fat Free Claims |
Foods should not
be allowed to claim that they are low in trans fat. We recommend eliminating
this row entirely from Schedule I, and otherwise prohibiting use of trans fat-free
claims. |
Any product
should be free of industrial trans fats with FSSAI’s recent implementation of
the “Food Safety and Standards (Food Products Standards and Food Additives)
Tenth Amendment Regulations, 2020” and “Food Safety and Standards (Prohibition
and Restrictions on Sales) Second Amendment Regulations, 2021”. Therefore, using
a trans fat-free claim would be misleading for consumers as all products
should be free from industrial trans fat. A trans fat-free claim would single
out products in an unwarranted way and constitute a form of misleading
marketing communication by creating a “health halo.” Additionally, using
a trans fat-free claim may create the impression that a product is a healthy
or healthier choice when such products may be high in other unhealthy fats
(e.g., saturated fat, which are often a replacement for trans fat) or other nutrients.
As reiterated throughout these
comments, foods should not be permitted to
promote the absence or presence of a single nutrient if the food contains
other nutrients known to worsen the risk of the disease. |
While strong recommendation is to
prohibit trans fat-free claims entirely, at a minimum such claims should only
be allowed for foods without excessive levels of other nutrients, including
saturated fat, sodium and sugars, as defined by a comprehensive nutrient
profile model. |
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Schedule I footnote Claims for a food which by its
nature shall not qualify for health claims. |
Schedule I of the current draft
regulations includes a footnote that states: “A food which, by its nature,
free from the nutrient/component shall not qualify for claiming free of that
nutrient/component.” We understand the intention of this
exclusion is to prohibit misleading nutrient claims on foods that never
contained the claimed nutrient, such as fat-free gummies or sugar-free ghee. However, the term “by its nature” is
not defined, which may lead to confusing about the meaning of this provision.
This exclusion should be amended to expressly
disqualify a health, nutrient, or reduction of disease risk claim for any
food that mislead consumers with any claims due to the inherent nature of the
food. Specifically, this exclusion should encompass foods that never included
the claimed nutrient. |
Without clarification, this
provision may give an unfair competitive advantage to unhealthy
ultra-processed foods, which would be permitted to advertise marginal
improvements in their products by promoting low levels of key nutrients. On
the other hand, this provision would disqualify naturally healthy and
unprocessed foods from using such claims. This could lead to illogical
results. For example, potato crisps could have a low sodium label, while
roasted nuts would not be eligible. |
The disqualification could also be
expanded to include any food that “by its nature” is counter to healthy diet
because it has excessive amounts of sodium, sugar, saturated fat, and other
nutrients in accordance with an established nutrient profile model. |
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Regulation. 7(3)/Schedule III Reduction of disease risk claims |
If a product contains an excessive
amount of a problematic nutrient (e.g., sodium, saturated fat, or
sugars), then promotion of potential benefits of its other qualities (e.g.,
high potassium reduces hypertension) should be prohibited. As with the nutrient claims above,
the best solution is to condition reduction of disease risk claims in
Schedule III on compliance with a comprehensive and quantitative nutrient
profile. For example, foods might only qualify for a reduction of disease
risk claim if: 1.
No more than 10% of energy of the finished product derives from
saturated fat; and 2.
The content of sodium in the finished product is less than 1 mg per
kcal; and 3.
No more than 10% of energy of the finished product derives from free
sugars. |
As with the nutrient claims above,
this suggested approach is consistent with Regulations 4(13), 8(2), and
10(6). |
The best option is to implement a
comprehensive nutrient profile model that sets limits for excessive levels of
particular nutrients. If it is not feasible to tie
reduction of disease risk claims to a comprehensive nutrient profile model,
then use of each reduction of disease risk claim should be at least conditioned
on the food having appropriate levels of those nutrients that directly
contribute to the stated health risk. For example, if a product claims
it contributes to lowering blood pressure because of its low sodium levels,
then that product should also have appropriately low levels of sugar and
saturated fat, as excessive consumption of these nutrients can increase risk
of cardiovascular disease. Note that this alternative requires
products to be “low in” nutrients in accordance with Schedule I, which is a
stricter standard than thresholds would be if a nutrient profile model set
standards for excessive levels. |
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Regulation 7(3)/Schedule III Limits for reduction of disease risk
claims |
The “low in,” “high in” and “source
of” thresholds that are required for reduction of disease risk claims in
Schedule III should be linked explicitly to the corresponding thresholds defined
in Schedule I. |
Some of the “low in,” “high in” and
“source of” limits that are required conditions to qualify for the reduction
of disease risk claims described in Schedule III (such as low in sodium, low
in saturated fat, low in total fat, source of calcium, high in Vitamin D) do
not have quantitative limits. Schedule III references, but does
not quantify, what constitutes the necessary level of several nutrients. It is crucial to have objective,
quantifiable, and consistent thresholds when a food is considered to meet the
required threshold for the relevant nutrient. |
We assume that the drafter intended
these terms to correspond to the limits set in Schedule I; however, this
relationship should be explicit in the regulations. |
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Schedule III(2) Sodium and hypertension claim
qualifications |
Regarding sodium and hypertension
reduction of disease risk claims, a food should only qualify for such claims
if the food does not have excessive levels of other nutrients that are known
to exacerbate cardiovascular disease, including sugar and saturated fat. |
Eating foods with excessive levels
of sugar or saturated fat can increase the risk of cardiovascular disease,
even if the food is low in sodium. |
As stated above, foods should not be
permitted to promote their ability to reduce disease risk if the food contains
other nutrients known to worsen the risk of the same or similar disease. |
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Schedule III(2) Sodium and hypertension claim
language |
Alternative language for the claim
statement regarding sodium and hypertension could better communicate the
potential benefits of reducing sodium. Specifically, we propose the following
claim statement: “Low sodium diets may reduce the risk of high blood pressure
and heart disease.” |
Using plain language, this text
accurately describes the relationship between sodium, blood pressure,
hypertension, and heart disease. The previous language did not reference
hypertension. |
Some consumers may not know that
high blood pressure can cause hypertension and other diseases like heart disease
and stroke. |
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Schedule III(3) Saturated fat and cholesterol claim
qualifications |
Regarding
dietary saturated fat and blood cholesterol reduction of disease risk claims,
a food should only qualify if the food has low levels of saturated fat and
does not have excessive levels of other nutrients, including sugar and
sodium, that are known to exacerbate harmful blood cholesterol or otherwise
increase disease risk. Furthermore, we
suggest eliminating the additional requirement that such foods also be low in
total fat and promote physical activity. |
Eating foods with excessive levels
of sugar and sodium can increase harmful cholesterol and cardiovascular
disease, even if the food is low in saturated fat. Physical activity is not part of a
person’s diet, but a complement. Mentioning physical activity might mislead
consumers to assume that physical activity can remedy an unhealthy diet. |
As stated above, foods should not be
permitted to promote their ability to reduce disease risk if the food contains
other nutrients known to worsen the risk of the same or related diseases. |
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Schedule III (3) Saturated fat and cholesterol claim
language |
Regarding dietary saturated fat and
blood cholesterol, the following language for a claim statement is suggested:
“Diets low in
saturated fat may reduce the risk of harmful blood cholesterol and heart
disease.” |
The original text did not recognize
that there are different types of cholesterols in the blood such as LDL and
HDL, and that only certain forms of cholesterol present a significant health
risk. |
The proposed language is also edited
to be more consistent with the suggested language for other reduction of
disease risk claim statements. |
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Schedule III(4) Potassium and blood pressure
qualifications |
Regarding potassium and the reduced
risk of high blood pressure, a food should only qualify for the reduction of
disease risk claim if the food does not have excessive levels of other
nutrients that are known to raise blood pressure or otherwise worsen
cardiovascular disease, including sugar and saturated fat. |
Eating foods with excessive levels
of sugar or saturated fat can raise blood pressure and lead to hypertension,
even if the food is low in sodium and a good source of potassium. |
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Schedule III(4) Potassium thresholds |
The regulations should provide a
clear standard for when a food is considered a “good source of potassium.” This objective standard could be
contained within relevant row (4) of Schedule III, or added as a new row to
Schedule I. |
It is crucial to have an objective,
quantifiable, and consistent threshold when a food is considered a “good
source of potassium.” Ideally, this standard should be set
appropriately to both inform the general population and to inform those who
need to monitor potassium consumption due to a medical condition, such as
hyperkalemia. |
This quantitative standard could be
contained within relevant row (4) of Schedule III, or added as a new row to
Schedule I. In Europe, for example, vitamins and
minerals may be declared a “significant amount” if they contain 15% or more
of the recommended daily allowed supplied by 100 g or 100 ml or per package
if the package contains only a single portion. We understand that India’s current
Recommended Daily Allowance for potassium is 3750 mg for men, 3225 mg for
women, 1550 mg for children 4 to 6 y, and 1100 mg for children 1 to 3 y. https://www.fssai.gov.in/upload/advisories/2020/01/5e159e0a809bbLetter_RDA_08_01_2020.pdf The food authority may look into the
examples from Europe where foods could take a similar approach to Europe, and
declare that, for example, foods with more than 562 mg (15% of 3750 mg) per
100 g or 100 ml satisfy the definition of a “good source of potassium.” |
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Schedule III(4) Potassium and blood pressure claim
language |
The reduction of disease risk claim associated
with high levels of potassium should also address the subpopulation who
should watch their potassium intake due to a medical condition such as
hyperkalemia. The following balanced language would
inform consumers about the benefits of increased potassium and decreased
sodium, while indicating that certain people may need to avoid the product: “Diets high in potassium and low in sodium may reduce the risk of
high blood pressure and heart disease. However, if you have been told to
limit potassium in your diet, please consult your doctor or other health care
professional before selecting this product.” |
While most consumers will enjoy
health benefits from eating more potassium, some people with certain medical
conditions, like hyperkalemia, should avoid foods with potassium. |
The same balanced language could be
used on packages of low sodium potassium-enriched salt substitutes, as a
replacement for the warning language currently contained in the Low Sodium
Salts section of the Draft Notification on Food Safety and Standards (Food
Products Standards and Food Additives) Amendment Regulations, 2021. |
Subject:
Draft Notification on Food Safety and Standards (Food Products Standards and
Food Additives) Amendment Regulations, 2021 related to Standards for Sheep
Milk, oils, Desiccated coconut, Wheat Flour or Resultant Wheat flour, millets,
Mithun (Bos frontalis), Limit on reducing sugar in sugarcane Jaggery and
Palmyrah Jaggery, Refined Iodized Salt, Low Sodium Salt, Dried Sweet Marjoram,
Coconut Neera, Liquid nitrogen dosing in ‘Natural Mineral Water’ and ‘Packaged
Drinking Water’, Substances added to Food, Microbiological Standards etc.
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Relevant
section in the draft notification on which comments are being provided |
Comments/suggestion |
Rationale |
Remarks |
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8(3) Low Sodium Salt |
The warning text required on low sodium salts should be
modified. We proposed the following language: “Diets high in potassium and low in
sodium may reduce the risk of high blood pressure and heart disease. However, if you have been told to limit
potassium in your diet, please consult your doctor or other health care
professional before use.” |
The current warning language for low
sodium salts fails to recognize the benefits of low sodium salts for the vast
majority of the population. Use of low-sodium/potassium enriched
salts, as defined in the draft regulation, combined with overall reduction in
sodium consumption, can reduce blood pressure and prevent hypertension. Most
consumers should be encouraged to replace traditional salt with potassium enriched
salt substitutes. For example, a recent study in rural
India concluded that reduced-sodium, potassium-enriched salt led to a
substantial reduction in systolic blood pressure in hypertensive patients,
supporting salt substitution as an effective, low-cost intervention for
lowering blood pressure in rural India. (Yu, J. et al., Effects of a reduced-sodium added-potassium
salt substitute on blood pressure in rural Indian hypertensive patients: a
randomized, double-blind, controlled trial, The American Journal of
Clinical Nutrition, Volume 114, Issue 1, July 2021, Pages
185–193, DOI:
10.1093/ajcn/nqab054) A similar study conducted in China
concluded that when eating salt substitutes instead of regular salt, the
rates of stroke, major cardiovascular events, and death from any cause were
lower among persons who had a history of stroke or were 60 years of age or
older and had high blood pressure. (B. Neal et al., Effect of Salt
Substitution on Cardiovascular Events and Death, N Engl J Med 385: 1067,
Sept. 16, 2021, DOI: 10.1056/NEJMoa2105675.) The label on qualifying packages of
low sodium salts should communicate two messages 1)
the benefits of potassium intake and 2) the risks of potassium intake for a
limited population. The proposed language also overemphasizes
the danger of potassium. Communicating
an unnecessarily severe warning (“To be consumed under medical supervision”)
to those who have no medical need to limit potassium could prevent them from
using a product from which they could actually benefit. Even for those people who should be
careful consuming potassium, the language is overly cautious. It is rarely
necessary for these individuals to require medical supervision when consuming
foods with potassium. Additionally, for the small
percentage of the population that do need to monitor their potassium intake
due to a serious medical condition, the proposed language is overly technical
in that it lists specific conditions but not others. |
Packages of potassium enriched salt
substitutes do not qualify for a reduction of disease risk claims under the
current regulations because their sodium levels are too high. Nevertheless, most consumers should be
encouraged to replace traditional salt with potassium enriched salt
substitutes. The proposed amendment would help achieve this by focusing on
the health benefits for most of the population rather than health risks for a
limited population. For products containing good sources
of potassium and low levels of salt (as described in Schedule III(2) of Draft
Notification on Food Safety and Standards (Advertising and Claims) Amendment
Regulations, 2021, we recommend including the use of
the same statement (“Diets high in potassium and low in sodium may reduce the
risk of high blood pressure and hypertension.
However, if you have been told to limit potassium in your diet, please
consult your doctor or other health care professional before use.”) in Schedule
III(4) of the Draft Food Safety and Standards (Advertising and Claims)
Amendment Regulations, 2021 |
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