CAAR rules that Glyteine (Gamma Glutamylcysteine), packaged in 415 mg. sachets and branded as Continual-G merits classification under sub-heading 21069099 of the first schedule to the Customs Tariff Act, 1975.
FULL TEXT OF THE ORDER OF CUSTOMS AUTHORITY FOR ADVANCE RULING, MUMBAI
An application for advance ruling has been received from Shri Sunil Chandarana on 07.06.2021. In the said application, a ruling has been sought on the classification of formulated Gamma Glutamylcysteine branded as Glyteine and sold as Continual-G in retail sales. According to the applicant, the said formulation merits classification under HS Code 3004.90.
2. The applicant, in their CAAR – I form, has indicated that they propose to import the intended goods through the Nhava Sheva port. Accordingly, the application was forwarded to the Principal Commissioner of Customs, Nhava Sheva – I, Jawaharlal Nehru Custom House. In their comments, it has been opined, after considering the product details/characteristics and explanatory notes, that the impugned formulation merits classification under heading 21.06. The comments received from the Principal Commissioner have been conveyed to the applicant and his rebuttal/rejoinder is on record.
3. The application was heard on 08.2021. Apart from the applicant, Shri Rajan Shah also appeared on behalf of the applicant. No one appeared on behalf of the Principal Commissioner, Shri Shah explained the product characteristics and argued that the proper classification of Continual-G is the heading 30.04. It was also informed that Continual-G is manufactured in the United States of America and supplied to many countries, including the European Union. Shri Shah stated that their main mode of sale is to retail consumers directly through courier and that they use the services of DHL for delivery. Shri Shah further stated that they classify Continual-G under HS Code 300490 in the USA but was not sure what classification is adopted for supplies to the EU. The applicant confirmed during the hearing that no application has been made to the Drug Controller of India seeking approval for use of Continual-G in India.
4. In the application for advance ruling, the applicant has provided the chemical structures of L-Cysteine, N-Acetylcysteine, Gamma-Glutamylcysteine, Glutathione, Acetic acid, and Acetic Anhydride in a pictorial manner. Based on the chemical structure, the applicant has claimed that L-Cysteine, N-Acetylcysteine (pure) and Glutathione (pure) have similar structures and should fall under the same heading, i.e., 2930.90. It is also stated that when N-Acetylcysteine and Glutathione are formulated for retail sale, they fall under the same namely, 3004.90; and that N-Acetylcysteine and Glutathionc are formulated for other uses, they are classifiable under heading 3003.90. The reason for the common classifications is that all these substances are not only chemically related, but also have similar applications. Glutathione is a tri-peptide, i.e., a small protein (all peptides are proteins) comprised of L-Glutamic Acid, L-Cysteine and Glycine and is chemically known as Gamma- Glutamylcysteinylglycine and/or Gamma-L-Glutamyl-L-Cysteinylglycine. L-Cysteine is one of the three starting amino acids for producing glutathione. L-Cysteine is not formulated due to its tendency to get oxidized when exposed to air. It is therefore used in pure form and sold in sealed containers. Its major uses are in the production of bread, manufacturing N-Acetylcysteine and the di-peptide Gamma-glutamyl-cysteine. N-Acetylcysteine is sold in pure form for use as an ingredient in formulations used in hospital emergency rooms and for IV injections. N-Acetylcysteine is also used as an ingredient in formulated products for retail sales and for self-use. Glutathione in pure form is used as an ingredient in formulations for use in hospital emergency rooms and for IV injections. Glutathione is also formulated with other ingredients for use in retail sales and for self-use. Gamma-Glutamylcysteine is a di-peptide and is the immediate precursor to glutathione. It is produced by the reaction between 1-Glutamic Acid and 1-Cysteine. Reacting Gamma Glutamylcysteine with Glycine results in Glutathione. This reaction occurs inside the cells in the human body. The main function of Gamma-Glutamylcysteine is to increase the quantity of Glutathione inside the body. Gamma-Glutamylcysteine is closely related both to L-Cysteine and to Glutathione and is the intermediate product formed between 1-Cysteine and Glutathione. The chemical name for Glutathione Gamma-Glutamylcysteinylglycine clearly shows that the first part of the name describes Gamma-Glutamyl-Cysteine. Gamma-Glutamylcysteine is available in pure form and is used as an ingredient in formulations with other ingredients and the manufacture of capsules. Gamma-Glutamylcysteine is also formulated for retail sale and for self-use. All 3 products, i.e., N-Acetylcystiene, Gamma-Glutamylcysteine and Glutathione have the same use, namely, increasing Glutathione levels in the body. Increasing Glutathione levels is important to improve immunity and also to provide a range of health benefits. The difference is in their performance and efficiency in increasing Glutathione levels. In light of the above, the applicant has suggested that the HS codes for Gamma-Glutamylcysteine should fall in the same category as those for Glutathione, as follows: –
5. The applicant has also stated that the synthesis of Glutathione proceeds via two sequential reactions. The first reaction takes place between L-Cysteine and L-Glutamic Acid to form Gamma-Glutamylcysteine as follows: –
The second reaction adds Glycine to Gamma-Glutamylcysteine to form Glutathione as follows: –
N-Acetylcysteine is produced by reacting L-Cysteine with Acetic Anhydride as follows: –
All organic compounds in a pure state containing the sulphur atom (with specific exceptions) have the HS code 2930.90. L-Cysteine is an organic chemical with a sulphur atom and, when in a pure state, has been assigned the HS code 2930.90. N-Acetylcysteine is formed by reacting L-Cysteine with Acetic Anhydride, also an organic chemical with the sulphur atom from L-Cysteine and, when in a pure state, has also been assigned the same HS code as L-Cysteine. Glutathione is an organic chemical with the Sulphur atom from L-Cysteine and, when in pure state, has been assigned the same HS code as L-Cysteine. Gamma-Glutamylcysteine is an organic chemical containing a sulphur atom. The sulphur atom in Gamma-Glutamylcysteine is the same as that in L-Cysteine and Glutathione, and hence, Gamma-Glutamylcysteine in a pure state should be included under the same classification for the purpose of the HS code (organic sulphur compounds) as both these chemicals, i.e., 2930.90. The HS code 2930.90 has been assigned for L-Cysteine, N-Acetylcysteine and lutathione when in a pure state. L-Cysteine is only sold in a pure state due to its relatively poor stability and is, therefore, never sold in a formulation. To incorporate L-Cysteine in formulations, N-Acetylcysteine is used since it functions effectively as L-Cysteine. Formulated N-Acetylcysteine has been assigned a separate HS code 3004.90 when sold to merchants who retail it to customers. Glutathione is often formulated with other ingredients for different applications. Glutathione in pure form is often purchased by formulators who blend it with other ingredients and sell it to merchants for sales. Formulated Glutathione has, therefore, been assigned a separate HS code 3004.90 when imported by merchants who sell these formulations to customers which is described as retail sales. Gamma-Glutamylcysteine is also formulated with other ingredients and sold to merchants who retail these formulated products to customers. Logically, therefore, formulated Gamma-Glutamylcysteine should be assigned the HS code 3004.30 which would be consistent with the HS code assigned to formulated N-Acetylcysteine and Glutathione used for retail sales. There is a separate HS code for “formulated N-Acetylcysteine for other uses” and for “formulated Glutathione for other uses”. Whereas, the expression “other uses” is not defined, self-use would fall under the classification of “other uses”. Many customers import formulated N-Acetylcysteine and formulated Glutathione for other self-use. The HS codes assigned to N-Acetylcysteine (formulated for other uses) and Glutathione (formulated for other uses) are identical, namely, 3003.90. Therefore, Gamma-Glutamylcysteine (formulated for other uses) which includes self-use, should also fall under the same classification, i.e., 3003.90.
6. In their rejoinder to the comments of the jurisdictional Principal Commissioner of Customs, the applicant has stated that, the WTO has assigned HS code 29.30 to pure Glutathione and 30.04 for formulated Glutathione for uses other than retail sale; that, WTO recognizes, based on the assigned HS codes, that mixed or unmixed, i.e., formulated or non-formulated Glutathione has therapeutic or prophylactic uses. The evidence that Glutathione has therapeutic use is extensive. The US government website https://pubmed.nchi.nim.nih.gov lists more than 161,000 scientific papers published on the relationship between Glutathione and a wide range of diseases. The number of issued patents on glutathione and diseases is similarly extensive. Formulated or mixed Glutathione is retailed in the form of dietary supplements and these supplements are expected to provide therapeutic and/or prophylactic benefits. These health benefits are achieved by increasing glutathione levels in the body. In the USA and several western countries, dietary supplements are required, by regulation, to publicly state that that the product is not intended to prevent, treat or cure any disease. However, all supplement manufacturers attempt to convey the health benefits of their products in different ways, since without either a therapeutic or prophylactic use, these products would not have a market. Healthcare practitioners have known for decades that Glutathione has therapeutic and prophylactic applications and routinely prescribe these supplements. The book Glutathione authored by Dr. Jimmy Gutman mentions a large number of diseases resulting from depleted cellular Glutathione. The book reports on the successful treatment of these diseases using a supplement Immunocal which is a whey protein concentrate containing bound Gamma-Glutamylcysteine. This is an example of a dietary supplement providing therapeutic benefits. The author, a practicing doctor in Canada, states that Glutathione plays a crucial role in helping prevent heart disease and stroke, helps the body fight inflammatory bowel disease, pancreatitis and many more. US Patent 9,442,092 claims the use of Glutathione or its precursor N-Acetylcysteine for treatment of autism. US Patent 10,406,200 B2 claims the use of pharmaceutical compositions containing glutathione for treating mucosal tissue disorders. This is an example of referring to a dietary supplement formulation as a pharmaceutical composition. US Patent 9,446,100 B2 claims that dietary supplements and formulations containing Glutathione or N-Acetylcysteine for treating type II diabetes. N-Acetylcysteine is used in the emergency room of hospitals in the USA for treating persons who have taken an overdose of Paracetamol. If not treated within a limited time, the overdose leads to failure of all organs leading to death. N-Acetylcysteine functions by producing Glutathione in the liver which detoxifies the Crocin. The book “The Therapeutic use of N-Acetylcysteine in medicine” is additional evidence that N-Acetylcysteine has therapeutic and prophylactic use. That, Gamma-Glutamylcysteine (Glyteine) rapidly raises cellular Glutathione levels, has been demonstrated in the paper by Zarka and Bridge. Once Glyteine has increased Glutathione levels, the therapeutic or prophylactic benefits provided by Glutathione become available. US Patent 20111/0086920 claims that Gamma-Glutamylcysteine can be used to treat oxidative damage caused by ischemia/reperfiision events such as pulmonary hypertension, transplant, cardiac bypass and other surgeries and traumas. A research paper published on an animal study has proved that oral supplementation with Gamma-Glutamylcysteine could reverse the effects of Alzheimer’s disease. A research paper shows that the disease “cystic fibrosis” can be successfully treated with Gamma- Glutamylcysteine. Glutathione, N-Acetylcysteine and Gamma-Glutamylcysteine, when consumed, perform one primary biological function, i.e., increase Glutathione with the objective of combating oxidative stress which, if unchecked, results in chronic inflammation. It is well established that chronic inflammation is the primary cause of chronic diseases such as asthma, Lyme disease, arthritis, pancreatitis and many more. Published research has concluded that the common factor in all these diseases is depleted cellular glutathione levels with the expectation that effective treatment would require raising Glutathione levels. This has found to be confirmed by customers of Continual-G. The summary of customers’ testimonials confirms that the Glyteine present in Continual-G functions therapeutically and is a prophylactic when used daily as recommended. N-Acetylcysteine has been commercially available since more than 50 years. Glutathione has been commercially available for more than 30 years. Scientists have had a long time to conduct research on potential therapeutic applications of both N-Acetylcysteine and Glutathione. Likewise, medical practitioners have been able to test both these products in treating a large number of diseases. Gamma-Glutamylcysteine has only been commercially available since October, 2019. Prior to that, it was only possible for scientists to conduct research and report their findings in scientific journals but medical practitioners could not try it in clinical practice until last year. For all new products for healthcare, their adoption in clinical practice is a slow process but that does not mean that they do not have therapeutic and prophylactic uses. Since, the only rapid way to increase cellular Glutathione is to consume Gamma-Glutamylcysteine, it is only a question of time before it is commonly used in clinical practice and knowledgeable people will start to purchase it directly as is the practice in the USA and Australia. Dr. Jody Confer is a specialist on Lyme disease and suffers from Lyme disease and in her email states that she was given Continual-G for her condition by Dr. Richard Horowitz from the Hudson Valley Healing Arts Centre in NY state and she found it to be excellent.
7. I have gone through the application, the additional submissions including the testimonials from customers confirming that they have experienced therapeutic benefits by consuming Glyteine present in Continual-G, the copies of the emails from Dr. Confer and Dr. Horowitz, the extracts of the US Census Bureau Trade Schedules, referred as WTO assigned HS codes, relevant extracts of the books and publications submitted by the applicant. The issue under consideration in the present advance ruling proceedings is the classification of Continual-G under the Indian customs tariff. From the copy of the product label submitted by the applicant, it appears that Continual-G is a preparation/formulation containing 415 mg. of Glyteine (Gamma Glutamylcysteine) along with Maltodextrin, Natural Flavours and Stevia in a single sachet. The product is represented as a dietary supplement and carries a statement to the effect that ‘These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease’ as a disclaimer to the information supplied under various heads, i.e., relevant scientific studies, purpose, when do we not have enough Glutathione, clinically tested, safety, etc. It is clear from the records before me that, despite claims of therapeutic and prophylactic properties of Continual-G, neither the United States Food and Drug Administration nor the Drug Controller of India have approved its clinical use for treatment of diseases.
8. In light of the above, I proceed to examine the tariff entries under the entry 300490 of the Indian customs tariff, which the applicant has claimed as the correct classification of their intended import. The types of products under the said entry of the first schedule to the Customs Tariff Act, 1975 are, Ayurvedic, Unani, Homoeopathic, Siddha or Bio-chemic systems medicaments, put up for retail sale; anthelmintics drugs, anti-amoebic and other anti-protozal drugs; anti-fungal drugs; anti-histaminics drugs; antacids preparations; anti-ulcer drugs; anti-emitics and other gastrointestinal drugs; anti-cancer drugs; anti-tubercular drugs; anti-leprotic drugs; anti-malarial drugs; non-steroidal anti-inflammatory, analgesics and anti-pyratic drugs; anti-hypertensive drugs; anti-epiliptic drugs; sulfa drugs not elsewhere specified or included, preparations of enzymes; veterinary medicinal preparations, not for human use, not elsewhere specified or included; oral rehydration salts; antibacterial formulations, not elsewhere specified or included; and sedatives and tranquilizers. From the above enumeration, it is abundantly clear that the product Continual-G, a formulation of Glyteine (Gamma Glutamylcysteine) do not merit classification under any of the entries under 300490. Chapter Note 1(a) to Chapter 30 also makes it clear that foods or beverages (such as dietetic, diabetic or fortified foods, food supplements, tonic beverages and mineral waters), other than nutritional preparations for intravenous administration (Section IV) are not covered under the said chapter. This reinforces the conclusion that Continual-G do not merit classification under Chapter 30. In so far as Glyteine, i.e., Gamma Glutamylcysteine is stated to be a reactive derivative of L-Cysteine and L-Glutamic Acid, and therefore, by virtue of Note 6. to Chapter 29, which is reproduced below, stands excluded from the Chapter 29 of the tariff.
‘The compounds of headings 2930 and 2931 are organic compounds the molecules of which contain, in addition to atoms of hydrogen, oxygen or nitrogen, atoms of other non-metals or of metals (such as sulphur, arsenic, or lead) directly linked to carbon atoms.
Heading 2930 (organo-sulphur compounds) and heading 2931 (other organo-inorganic compounds) do not include sulphonated or halogenated derivatives (including compound derivatives) which, apart from hydrogen, oxygen and nitrogen, only have directly linked to carbon the atoms of sulphur or of a halogen which give them their nature of sulphonated or halogenated derivatives (or compound derivatives).’
9. In light of the above, I now proceed to examine the heading suggested by the jurisdictional Principal Commissioner of Customs, i.e., heading 2106. According to the jurisdictional Principal Commissioner of Customs, Explanatory Notes to CTH 3004 provides that the heading 3004 includes medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the. form of transdermal administration systems) or in forms or packings for retail sale, whereas, Continual-G is not for therapeutic or prophylactic uses as it is prepared neither for treatment of any kind of disease nor it prevents any disease. Note 5(b) to chapter 21 states that preparations for use, either directly or after processing (such as cooking, dissolving or boiling in water, milk or other liquids), for human consumption are included in the said heading. The product literature provided by the applicant suggests consumption of one sachet of CONTINUAL-G up to twice daily mixed with 5 ounces (150 m.) of water and that for exercise and training take 90 minutes beforehand while for normal daily use, it can be taken at any time. I have already taken note of the disclaimer that the statements made in respect of the therapeutic and prophylactic properties of Continual-G have not been evaluated by the Food and Drug Administration of the United States of America and also that the product is not intended to diagnose, treat. cure, or prevent any disease. Taking into account all the material before me, it is my considered opinion that the product Continual-G merits classification under heading 2106 of the tariff and not under 3004 as suggested by the applicant.
Based on the aforementioned discussions, I rule that Glyteine (Gamma Glutamylcysteine), packaged in 415 mg. sachets and branded as Continual-G merits classification under sub-heading 21069099 of the first schedule to the Customs Tariff Act, 1975.