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Withdrawal notice for Nutraceutical ingredients by Indian FDA (FSSAI) citing safety reasons

FSSAI notifies the approved and prohibited list of ingredients under Nutraceutical regulations after safety assessment

Regulations for Nutraceuticals were notified by FSSAI on 23rd December 2016 which also includes product categories like health supplements, food for special dietary and medical purposes. With introduction of these regulations the Authority approved various ingredients, formulations and nature to the final product. However, due to lack of data and paucity of time many ingredients which are already in the market were not included in the system. As a result of this, food industry represents to standard setting division for inclusion of omitted ingredients into the approved database.
Based on such representations, the Food Authority conducts safety assessment by collecting data, consulting scientific panel and timely notifies these amendments with discretion. During this process the food business operators (FBOs) are required to provide adequate information and aid in the decision making process of the ingredient. Subsequently, there are always possibilities of the following.
  • With FBO providing data, FSSAI can decide whether ingredient
    • is approved
    • is unsafe and should be withdrawn or recalled
    • require further assessment of data
  • FBO chose to withdraw the application due to lack of additional data requested by FSSAI
    • Ingredient is deemed as rejected and the Authority provides 30-40 days time to provideadequate data
Considering the above two scenarios, FSSAI has come up with a notification on 29th June 2018 with list of ingredients considering the above mentioned scenarios

Revised list of ingredients as per the recent notification from FSSAI
FSSAI consideration factor
List of ingredient modification
Further instruction from FSSAI
Ingredients approved by the Authority in the amendments
1. S-acetyl glutathione (50-60 Mg/ day/ Max)

2.  Alpha-cyclodextrin

Ingredients considered as redundant due to withdrawal of application by FBO
1.       Succinic Acid

2.       Inosine
FSSAI has given time of 30 days to furnish additional data in this regard for further assessment

Ingredients resricted by FSSAI from being used in food products as these exhibit the properties of drug
1.       Ipriflavone

2.       Polypodium leucotomos
However, these ingredients are allowed to be used in products till september 2018

14 ingredients ordered to be suspend by FSSAI for lack of adequate safety data and no furhter manufacturing of these products using these ingredients is allowed till futher assessment
1.       Raspberry ketone
2.       Slica
3.       Angelica sinensis
4.       Paullinia cupana
5.       Saw palmetto
6.       Notoginsing
7.       Chlorella growth factor
8.       Pine bark extracted to pinus radiate
9.       Pine bark extracted from pinus pinaster
10.    Vitamin D3-veg
11.    Chaga extrct
12.    Oxalobacter formigene
13.    Phytavail iron
14.    Tea tree oil
FSSAI has given time of 30 days to furnish additional data in this regard for further assessment

Ingredients banned by FSSAI due to safety concerns

1.       Para amino benzoic acid (PABA)

2.       Vanadium

3.       Prenolit

4.       Selenium dioxide
No further manufacturing or import of products with these ingredients is allowed. Also, an immediate withdrawal is required for the products already in the market

 Legend (* - for ease of interpretation)

Unsafe and banned by Authority

Ordered for discontinuation and further evaluation of data required

Out of Authority purview and is not a food ingredient

Approved by FSSAI

Currently as per the notification, consumers should be watchful in purchasing the products that processes unsafe ingredients i.e. depicted in red color in the above table. Further, the Food business including e-commerce market places (where these products are sold rampantly) are required to comply with the instructions and immediately withdraw the products that contain these ingredients and avoid penal action from FSSAI

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