Nutraceutical or a drug

Nutraceutical or a drug

Dr KK Aggarwal

President CMAAO and HCFI

Experts from Central Drugs food Standard Control Organisation (CDSCO) and the Food Safety and Standards Authority of India (FSSAI) are debating how to decide a product as a drug or food. Most companies like to launch a food supplement to escape the price control.

The blurred line between drug and supplements surfaced in 2009 when the drug price regulator National Pharmaceutical Pricing Authority (NPPA) said that pharma firms are marketing drugs as food supplements to escape the price control.

The joint expert committee of CDSCO and FSSAI formed is meant to ascertain whether the products and ingredients marketed are labelled on the basis of their intended effects on the human body and further to be classified as drugs, vitamins or food.

Submissions be experts say that vitamins need to be allowed

both in health and nutritional supplements if they are within the recommended dietary allowance (RDA) stipulated by Indian Council of Medical Research (ICMR).

It further elaborates that the issue is more of recognizing RDA as the basis and not the ceiling in daily intakes of nutrients.

The submission recommends that vitamins should be allowed both in food as well as drug, depending on the dosages  employed. [Pharmabitz]

FSSAI issues advisory to stop putting toys and gift items inside food packets

Dr KK Aggarwal

Vide an order F. No. 12(4)2016/Misc/RCD/FSSAI, dated 22^nd July, the Food Safety and Standards Authority of India (FSSAI) has issued an advisory regarding non-food items that are packed as free toys and gift items with food products stating that such non-food items if swallowed accidentally by children may endanger their health and also their life.

The advisory further stated that “Considering safety of public at large, there is a need to discourage food businesses from providing any toy or gift items inside food packages, especially in the case of food which is likely to be ingested directly by an infant or a small child. Such promotional free toys or gift items may be provided separately or packed separately… The colour, texture and nature of toy or gift item should not at all resemble the food product inside food package.”

The Advisory urges commissioners of food safety of all states to make efforts to create awareness amongst the stakeholders to discourage such practices of packing toys with food products.

As per section 3(1) zz(xi) of the Food Safety and Standards Act, 2006, “unsafe food” means an article of food whose nature, substance or quality is so affected as to render it injurious to health by virtue of being misbranded or sub-standard or food containing extraneous matter.

(Source: FSSAI)

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

Only foods that contain 20 mg gluten/kg or less can be labelled as 'gluten-free', says FSSAI

Recognizing the challenges faced by celiac patients, Food Safety and Standards Authority of India (FSSAI) has established the standard for 'gluten free foods' and their labelling requirements under the Food Safety and Standards Regulations, 2011. It has released a guidance note, set up standards and made easy to perform rapid tests available for the common consumer. The key takeaways from the guidance note:

People with celiac disease should not consume food product containing gluten (wheat, barley etc.)

·         Only foods that contain 20 mg gluten/kg or less can be labelled as 'gluten-free'.

·         The patients with celiac disease should:

o    Buy foods that are labelled 'gluten- free'.

o    Check the ingredient list and confirm that there is no gluten in the food.

o    Check the food package for 'gluten free' label in the immediate proximity of the name of the product.

o    Should not buy flour from local mills where wheat may also be grounded for other customer and there are high chances of cross contamination.

o    Check FSSAI license number on the package(s).

o    Always read the manufacturing/ packaging date and best before date before buying food.

o    Check the labels, even on foods one buys regularly, as there may be some changes in ingredients used and that may contain gluten.

(Source: FSSAI)

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

FDA approved vs FDA cleared

Dr KK Aggarwal

(CNET Excerpts): The FDA (DCGI and FSSAI) is responsible for telling us which foods, drugs and medical devices are safe for us to use.

There is a big distinction between a drug or medical device that has been FDA approved and those that are FDA cleared. It's important to understand the difference.

What does the FDA regulate?

·         Prescription drugs for humans and animals

·         Over-the-counter drugs

·         Biologics (e.g. vaccines, blood products, biotechnology products and gene therapy)

·         Dietary supplements (not all are subject to FDA regulation)

·         Medical devices (everything from tongue depressors to pacemakers)

·         Surgical implants

·         Food additives

·         Cosmetics

·         Products that give off radiation (e.g. X-rays, microwave ovens)

·         Nicotine replacement therapy  (NRT) products

·         Infant formula

What does 'FDA approved' mean?

"FDA approved" means that the agency has determined that the "benefits of the product outweigh the known risks for the intended use."

Manufacturers must submit results of clinical testing in order to get approval.

When deciding to approve a product or drug, the FDA has to decide if the benefits outweigh the risks. The FDA is usually inclined to approve a product that has a higher risk if the potential benefit is significant -- like an artificial heart valve that can save someone's life.

What products need to be FDA approved?

FDA approval is usually mandatory to market or sell products that might have a significant risk of injury or illness, but can also benefit your health -- such as prescription medications, over-the-counter medications, vaccines and Class III medical devices.

The FDA categorizes medical devices into Class III, Class II and Class I. Complex medical devices that are implanted in your body, are life-sustaining, or have the potential to cause significant injury or illness in the body are in Class III. Those include implanted pacemakers, replacement heart valves and even breast implants.

Lower-risk devices and products used outside of the body, like condoms, motorized wheelchairs and bandages, fall into Class II and Class I. For reference, Apple's ECG app for the Apple Watch is in Class II.

What does 'FDA cleared' mean?

Class II and Class I medical devices are usually "cleared" by the FDA, which means the manufacturer can demonstrate that their product is "substantially equivalent to another (similar) legally marketed device" that already has FDA clearance or approval. Those already-cleared products are called a predicate.

Once the FDA declares that a new medical device is substantially equivalent to a predicate, it is "cleared," and can be marketed and sold in the US.

The system isn't perfect

The problem with the FDA's approval system is that often companies get their product cleared by using older predicates that were recalled for safety reasons.

FDA does not develop any of the products it evaluates for approval. Nor does it conduct its own testing -- instead, it reviews the results of independent lab and clinical testing to determine if the product, drug or food additive is safe and as effective as it claims to be.

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

Low gluten food labels to be out with only 'gluten free' label to stay

A gluten-free diet is one that that does not contain the protein gluten. Gluten is found in grains such as wheat, barley and rye (sometimes in oats).Gluten causes inflammation in the small intestines of people with celiac disease. A gluten-free diet is required by patients with celiac disease (1% population) as it helps to control signs and symptoms and prevent complications.

Earlier in 2016, the FSSAI had notified the Food Safety and Standards (Food Products Standards and Food Additives) Second Amendment Regulations, 2016 relating to standards for gluten food and low gluten food. Correspondingly it made changes in Food Safety and Standards (Packaging and Labelling) Regulations, 2011 in packaging labels for gluten free and low gluten foods (rice, millets, ragi, oats, rye, barley, maize, wheat, pulses and legumes) specially processed to reduce gluten content to a level 20-100mg/kg.

Under these new regulations, FSSAI defined gluten-free food as food that consists of or is made of one or more ingredients containing rice, millets, ragi, pulses or legumes. A “gluten-free food” is one in which gluten levels are below 20 mg/kg. It also said that 

“A food which, by its nature, is suitable for use as part of a gluten free diet shall not be named as ‘special dietary’, “special dietetic” or any other equivalent term, however, such food may bear a statement on the label that ‘this food is by its nature gluten-free’.”

The Gluten-Free Food Labeling Final Rule issued by the US FDA in 2015 has defined "gluten-free" as meaning that the food either is inherently gluten free; or does not contain an ingredient that is:

·         a gluten-containing grain (e.g., spelt wheat);

·         derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); or

·         derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 ppm or more gluten in the food. Also, any unavoidable presence of gluten in the food must be less than 20 ppm. That is the lowest level that can be consistently detected in foods using valid scientific analytical tools. Also, most people with celiac disease can tolerate foods with trace amounts of gluten without causing adverse health effects. 

Why didn’t FDA adopt zero ppm gluten rather than less than 20 ppm gluten as one of the criteria for a food labeled gluten-free?

FDA used an analytical methods-based approach to define the term gluten-free and adopted < 20 ppm gluten as one of the criteria for a food labeled gluten-free because the agency relies upon scientifically validated methods for enforcing its regulations. Analytical methods that are scientifically validated to reliably detect gluten at a level lower than 20 ppm are not currently available. In addition, some celiac disease researchers and some epidemiological evidence suggest that most individuals with celiac disease can tolerate variable trace amounts and concentrations of gluten in foods (including levels that are less than 20 ppm gluten) without causing adverse health effects. (https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm362880.htm) 

As per the FSSAI draft Food Safety and Standards (Labelling and Display) Regulations, 2018: The term “Gluten Free” shall be printed in the immediate proximity of the name of the product in the case of products described in regulation 2.14 of the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, namely ‘Gluten Free’.

The term “Low Gluten” shall be printed in the immediate proximity of the name of the product in the case of products described in regulation 2.15 of the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, namely: “Low Gluten”. The label shall carry a ‘warning’ that ‘the food labeled as Low Gluten may pose a risk for those with celiac disease.

But now the FSSAI has decided to take “Low gluten” label out of the regulation as in celiac disease no amount of gluten is safe. 

HCFI Recommendations

·         The term “Low gluten foods” to be taken out of the label.

·         Gluten free should instead be labeled as zero gluten (since the public perception is that gluten-free means some amount of gluten is allowed).

·         Awareness should be created that ‘beer’ contains gluten and is harmful to gluten sensitive population. The harm reduction alternative is honey water wine, which has < 3% alcohol.

·         There should be options for gluten-free foods in airlines and trains.

·         In all parties, marriages and restaurants, there should be a provision for gluten free foods. Medical associations should pass a resolution to this effect on priority.

·         Non-celiac wheat sensitive persons (up to 10% of the population) should be offered wheat-free food options.

·         Wheat available in the market should also be labeled as high gluten wheat and low gluten wheat (both are harmful to celiac disease but low gluten wheat may have some solution for non-celiac wheat sensitive persons).

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

FSSAI agrees to reduce the content of trans fats from 5% to 2% in all edible vegetable oils and fats on the representation of HCFI

The US Food and Drug Administration (FDA) has banned artificial trans fats from American restaurants and grocery store food items. The FDA had deemed trans fats as unsafe in the year 2015 and gave time to all the companies in America until June 18, 2018 to eliminate the ingredient i.e. trans fat from their use.

The trans fats have been a staple in the tastiest junk foods for more than 100 years. The FDA ban applies to artificial trans fats, which are made chemically by adding hydrogen to vegetable oil (partially hydrogenated oil is also trans-fat). Trans fats increase the shelf life of packaged foods, and restaurants like to use it as oil for deep frying because it does not need to be changed as often as other oils.

The FDA’s move to provide an ultimatum for the ban of trans fats in American restaurants is a highly welcome one and should be replicated with immediate effect in India as well. The health effects of these are not unknown but consumption in various forms continues, particularly when it comes to eating outside food. Trans fats are a byproduct of the chemical reaction that turns liquid vegetable oil into solid margarine or shortening and that prevents liquid vegetable oils from turning rancid. Trans fats boost LDL as much as saturated fats do. They also lower protective HDL, enhance inflammation and increase the tendency for blood clots to form inside blood vessels.

Trans fats are created by pumping hydrogen molecules into vegetable oils. This changes the chemical structure of the oil, turning it from a liquid into a solid. The process involves high pressure, hydrogen gas, and a metal catalyst – and the end-product is highly unsuitable for human consumption.

Foods rich in trans fats tend to be high in added sugar and calories. Over time, these can pave way for weight gain and even type 2 diabetes, not to mention heart problems. It is time to take a strong stand against their use in eateries outside considering the fact that many people eat in restaurants regularly in today’s day and age.

In view of the above, Heart Care Foundation of India (HCFI) humbly requested the Hon’ble Prime Minister, Hon’ble Minister of Ministry of Health and Family Welfare and Hon’ble Minister of Ministry of Law & Justice vide representation dated 21.06.2018 to take immediate steps and to pass necessary directions thereby banning the use of trans fat in all restaurants, cafes, hotels, grocery items in India also, in the same manner as it has been banned in America.

HCFI also requested them to pass necessary discretions and to take necessary action for creating awareness among the public at large and for encouraging the public at large to:

      i.        Choose foods lower in saturated fats, trans fats and cholesterol.

     ii.        Replace saturated and trans fats in their diet with mono- and polyunsaturated fats. These fats do not raise LDL (or “bad”) cholesterol levels and have health benefits when eaten in moderation. Sources of monounsaturated fats include olive and canola oils. Sources of polyunsaturated fats include soybean, corn, sunflower oils, and foods like nuts.

    iii.        Choose vegetable oils (except coconut and palm kernel oils) and soft margarines (liquid, tub, or spray) more often because the combined amount of saturated and trans fats is lower than the amount in solid shortenings, hard margarines, and animal fats, including butter.

   iv.        Most fish are lower in saturated fat than meat. Some fish, such as mackerel, sardines and salmon, contain omega–3 fatty acids that are being studied to determine if they offer protection against heart disease.

    v.        Limit foods high in cholesterol such as liver and other organ meats, egg yolks and full–fat dairy products, like whole milk.

   vi.        Choose foods low in saturated fat such as fat free or 1% dairy products, lean meats, fish, skinless poultry, whole grain foods and fruit and vegetables.

The said representation of HCFI has been duly accepted by the Central Government and vide letter dated 01.08.2018, the Food Safety and Standards Authority of India (FSSAI) has stated that the FSSAI is in the process of notifying the limits of trans-fat in all edible vegetable oil and fats to be not more than 2% by weight in a phased manner by 2022. The relevant portion of the letter dated 01.08.2018 is reproduced hereunder:

“Please refer to grievance dated 26.06.2018 with registration no. PMOPG/D/2018/0229751 regarding banning use of trans-fat in all restaurants, cafes, hotels, grocery items in India. In this regard, it is informed that the Food Safety and Standards (Food products Standard and Product Additives) Regulations, 2011, prescribe that the trans-fat shall not be more than 5% by weight in some types of vegetable fats. Further, the FSSAI is in the process of notifying the limits of trans-fat in all edible vegetable oils and fats to be not more than 2% by weight in a phased manner by 2022. The other concerns regarding creating awareness among the public have been noted.”

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Immediate Past National President IMA

 

Every food-borne illness outbreak should be treated to its source

Recently, the CDC investigated a multistate outbreak of E. coli in the US and sourced it to Romain lettuce grown from the Yuma, Arizona growing region, although no particular grower, supplier, distributor, or brand has been identified. Further to this, the CDC issued an advisory for the consumers as well as retailers and restaurants.

For consumers, the CDC has recommended that they should “ask retailers where their romaine lettuce was sourced from and not eat or buy chopped romaine lettuce from Yuma, Arizona. If you have already bought products containing chopped romaine lettuce, such as bagged salads, salad mixes or prepared salads, throw them away and do not eat them”. Similarly, the CDC has asked retailers, restaurants, and other food service operators to not sell or serve any chopped romaine lettuce from the winter growing areas in Yuma, Arizona. If the source of the chopped romaine lettuce cannot be determined, then it should neither be sold nor served.

Food adulteration is not uncommon in India. Stories of food adulteration, are often covered by media. Milk and milk products, food grains, pulses, flour, condiments, sugar, spices and condiments, vegetables, salt are amongst the most common adulterated foods. The last major food recall across the country perhaps was for Maggi Noodles in 2015 due to lead content beyond the permissible levels.

In India, most cases of food contamination are passed off as food poisoning. The patient is treated for his symptoms and the matter ends there.

The Food Safety and Standards Authority of India (FSSAI) has issued guidelines for food recall by food business operators (FBO). Released last year, these guidelines require all FBOs engaged in the manufacturing, or importing, or wholesale supply of packaged food products to have a recall plan. An FBO is a person who carries on any activity related to manufacture, process, packaging, storage, transportation, distribution or import of food or provides food services. However, FBOs in food retail service sector (such as restaurants, caterers, take-away joints, etc.) who are not engaged in the foregoing activities are not required to have a recall plan.

The onus is on the FBOs to have a recall plan and implement it. Is there a system in place to check if these guidelines are implemented, if at all in the first place and then how stringently are they being implemented? To ensure food safety and thereby public health, there should be no exemptions to these guidelines.

Food adulteration is a punishable offence under the Indian Penal Code: Adulteration of food or drink intended for sale (IPC 272) and sale of noxious food or drink (IPC 273).

Every food-borne illness outbreak should be treated to its source like in the US and an advisory or health warning issued for the general public.

When will we reach such a level in India?

Dr KK Aggarwal

Padma Shri Awardee
Vice President CMAAO
Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Immediate Past National President IMA