High Time for including Nutritious Hemp Seeds in FSSAI in India

The documented use of cannabis in India period back from the Vedic period. Consumption of cannabis in colonial India was found to be so extensive that the Indian Hemp Drugs Commission consisting of Indian and British doctors determined in 1894 that its use was very ancient, and had some religious sections too. Also, having some immense benefits, this is known as an ancient Ayurvedic super food, which acts as a natural immunity booster, weight loss supplement, regulates blood glucose, and cholesterol. It is also considered as a nutritious plant-based diet that features a balanced ratio of Omega acids, antioxidants, and essential minerals. Hemp Seed Oil, which is cold-pressed, is better for the skin and hair and maybe consumed or applied to the body.

What is FSSAI and what’s the reason for it, when it comes to the investigation of cannabis?

Every food business in India requires permission from the Food Authority in India, i.e., the Food Safety and Standards Authority of India. The agreement to run a food business in India is required for any activity concerning manufacturing, storing, selling, distributing, packing, re-packing, etc. of any food items. The FSSAI is the sole authority in India to grant the various sorts of FSSAI license and registration to Food Business Operators (FBOs).

There is significant interest within the development of therapies and other consumer products derived from cannabis and its components, including cannabidiol (CBD). FDA recognizes the potential opportunities that cannabis or cannabis-derived compounds may offer and acknowledges the many interests in these possibilities. However, the FDA is aware that some companies are marketing products containing cannabis and cannabis-derived compounds in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act), which may put the health and safety of consumers in danger. The agency is committed to protecting public health while also taking steps to enhance the efficiency of regulatory pathways for the lawful marketing of appropriate cannabis and cannabis-derived products. FDA features some resources available that address cannabis and cannabis-derived products, like CBD, and therefore the agency wants to make sure that buyers and other stakeholders have access to those resources during a centralized location.

Problems along the way

Presently no standards have been prescribed for Hemp and Hemp products under the Food Safety and Standards Act 2006, Rules and Regulations made thereunder. There is also a lack of data and information on the variety of the plant to be used in the manufacturing process. The Scientific Committee at FSSAI believes that sufficient safety data would be required for a detailed assessment. In the absence of insufficient data and detailed risk assessment, the Scientific Committee has recommended not to consider the standardisation of hemp at this stage.

It came to the notice of the FSSAI that some FBOs that have a food license issued by the State Licensing Authorities are selling food products in the name of hemp products. All such activities are illegal and unauthorized under food laws. The FSSAI had also issued letters to the e-commerce platforms to remove all such products from their websites immediately and confirm the action taken to the FSSAI.

In a letter dated 17 October 2017, the FSSAI has stated that some companies are using the FSSAI License number, on their product labels to illegally manufacture, import, or sell products made from hemp and hemp seeds. A report by FSSAI says that hemp is being illegally sold by various companies. They are being sold under various brand names with or without the FSSAI License number through various e-commerce platforms.

The start-up faced difficulties while marketing its product since social media channels didn't allow any promotions to be run with the word hemp or cannabis, or any creative or logo that has a cannabis leaf on it.

So, Hemp seeds protein powder and hemp seed oil are often utilized in human food?

FDA completed its evaluation of three generally recognized as safe (GRAS) notices for the subsequent hemp seed-derived food ingredients: hulled hemp seed, hemp seed protein powder, and hemp seed oil. FDA had no questions regarding the company’s conclusion that the utilization of such products as described within the notices is safe. Therefore, these products are often legally marketed in human foods for the uses described within the notifications, provided they suit all other requirements. These GRAS notices are related only to the utilization of those ingredients in human food. To date, FDA has not received any GRAS notices for the utilization of hemp-derived ingredients in animal food.

The GRAS conclusions can apply to ingredients from other companies if they're manufactured in a way that's according to the notices and that they meet the listed specifications. A number of the intended uses for these ingredients include adding them because of the source of protein, carbohydrates, oil, and other nutrients to beverages (juices, smoothies, protein drinks, plant-based alternatives to dairy products), soups, dips, spreads, sauces, dressings, plant-based alternatives to meat products, desserts, food, cereals, snacks, and nutrition bars. Products that contain any of those hemp seed-derived ingredients must declare them by name on the ingredient list.

Foods containing hemp seed and hemp seed-derived ingredients are currently marketed. And hemp seed-derived ingredients that are the topic of the GRAS notices contain only trace amounts of THC and CBD, which the seeds may devour during harvesting and processing once they are in touch with other parts of the plant. Consumption of those hemp seed-derived ingredients isn't capable of creating consumers "high."

Future of hemp seeds

There are three types of cannabis derivatives in India like — bhang, charas, and ganja — regulated by the varied state excise departments and in the future, for sure in your locality also, there will be more legally sold hemp seeds by licensed shops.

But, it's important to conduct medical research into the security and effectiveness of cannabis products through adequate and well-controlled clinical trials. We welcome the chance to speak with states who are considering support for medical research of cannabis and its derivatives so that we can provide information on Federal and scientific standards.

To conduct clinical research that will cause an approved new drug, including research using materials from plants like cannabis, researchers have to work with the FDA and submit an IND application to the middle for Drug Evaluation and Research (CDER). The IND application process gives researchers a path to follow that has regular interactions with the FDA to support efficient drug development while protecting the patients who are enrolled within the trials. For research to be used as an animal drug product, researchers would establish an investigational new animal drug (INAD) file with the middle for the medicine to conduct their research.

This is important to understand that while brands may use it, consumers in India (and in most other countries) cannot merely buy CBD over the counter, unlike hemp seed oil. CBD is important oil, which needs a carrier. So, you'll get to use it either as a part of a formulation or mixed with other oil. But we still don’t know what the optimal amount of carrier oil should be.

Conclusion

We try our best to be conscious of the state, and native authorities that they're fielding numerous questions on the legality of CBD. There's ongoing communication with state and native officials to answer questions on requirements under the FD&C Act.

To understand the landscape at the state level better, and to otherwise engage with the nation's regulatory partners, we at Himalayan Hemp have been keeping you updated with information on the developments in India and therefore, the world that has an impact on our health and wellbeing. Have a look around our website and join us if you wish to.