1 DAY LEFT! Regulations Threatening Your Supplements
- by: Alliance for Natural Health USA
- recipient: US Food and Drug Administration (FDA) and U.S. Congress
The FDA has released draft guidance that will effectively prevent the creation of new nutritional supplements, restricting consumers to those formulated before 1994.
Supplements that are currently available but which weren't sold prior to 1994 in exact form will now be labeled as "new," which will force them to go through a lengthy and complicated "notification" process with the FDA -- in reality, a pre-market approval process, which Congress never intended to create.
The guidelines will allow the FDA to simply reject the notifications for many products -- which means they won't be approved for sale any longer. In other words, many supplements could be banned, despite there being no evidence they've every harmed anyone!
The FDA's deadline for comments is December 2. Please tell the FDA to develop more reasonable guidelines!
Supplements that are currently available but which weren't sold prior to 1994 in exact form will now be labeled as "new," which will force them to go through a lengthy and complicated "notification" process with the FDA -- in reality, a pre-market approval process, which Congress never intended to create.
The guidelines will allow the FDA to simply reject the notifications for many products -- which means they won't be approved for sale any longer. In other words, many supplements could be banned, despite there being no evidence they've every harmed anyone!
The FDA's deadline for comments is December 2. Please tell the FDA to develop more reasonable guidelines!
Dear [Decision Maker],
I am greatly concerned about the FDA's draft guidance on New Dietary Ingredient notifications for dietary supplements.
First, the FDA's interpretation of "new dietary ingredient" is far too broad. Under the new rules all ingredients in the food supply before 1994 that have been chemically altered in any way are considered NDIs and are therefore subject to NDI notification. And the agency's "chemically altered" definition includes using a botanical ingredient at a different life stage than was used previously -- for example, using extract of unripe apples instead of ripe apples. How absurd!
Second the FDA's decree that a synthetic copy of an herbal extract or other botanical is not considered a dietary ingredient is a completely arbitrary designation (particularly as this standard does not apply to non-botanicals), and will make many dietary ingredients on the market illegal.
But third, and most importantly, the NDI notification process becomes burdensome and repetitive -- for example, the guidance makes the NDI notification specific to the manufacturer, not the ingredient. So fi two manufacturers are marketing the same ingredient, at the same quantity, they still each have to submit an NDI notification. It also requires a different notification for the same ingredient for every different version of the supplement it is in -- for example, the same ingredient at a higher concentration needs a separate notification/approval. The same ingredient in a different combination of ingredients requires yet another notification. These notifications in effect create a pre-approval process, contrary to Congress' intent.
[Your comments will be inserted here]
The broad interpretation of NDIs, and the unreasonable and burdensome standards for the NDI notification ensures that the FDA will turn down many NDI notifications -- effectively turning the notification process into pre-approval process. Both this guidance and the bill Senator Dick Durbin recently introduced in Congress seek to give the FDA broad new authority to disapprove supplements or supplement ingredients on unknown or arbitrary grounds, with no rules or standards. If allowed to stand, over time this will drastically reduce the number and potency of supplements, raise prices substantially and impair our ability to take care of our own health.
When Congress passed the Dietary Supplement Health and Education Act in 1994, they intended the NDI notification system to be just that: a notification, not a stand-in for a lengthy and complex FDA per-market approval process. DSHEA was written to protect the right of access of consumers to safe dietary supplements. As a consumer who relies on the availability of nutritional supplements for my family's health, I don't want FDA's new guidance to cause my supplements to become unavailable.
Sign PetitionSign PetitionI am greatly concerned about the FDA's draft guidance on New Dietary Ingredient notifications for dietary supplements.
First, the FDA's interpretation of "new dietary ingredient" is far too broad. Under the new rules all ingredients in the food supply before 1994 that have been chemically altered in any way are considered NDIs and are therefore subject to NDI notification. And the agency's "chemically altered" definition includes using a botanical ingredient at a different life stage than was used previously -- for example, using extract of unripe apples instead of ripe apples. How absurd!
Second the FDA's decree that a synthetic copy of an herbal extract or other botanical is not considered a dietary ingredient is a completely arbitrary designation (particularly as this standard does not apply to non-botanicals), and will make many dietary ingredients on the market illegal.
But third, and most importantly, the NDI notification process becomes burdensome and repetitive -- for example, the guidance makes the NDI notification specific to the manufacturer, not the ingredient. So fi two manufacturers are marketing the same ingredient, at the same quantity, they still each have to submit an NDI notification. It also requires a different notification for the same ingredient for every different version of the supplement it is in -- for example, the same ingredient at a higher concentration needs a separate notification/approval. The same ingredient in a different combination of ingredients requires yet another notification. These notifications in effect create a pre-approval process, contrary to Congress' intent.
[Your comments will be inserted here]
The broad interpretation of NDIs, and the unreasonable and burdensome standards for the NDI notification ensures that the FDA will turn down many NDI notifications -- effectively turning the notification process into pre-approval process. Both this guidance and the bill Senator Dick Durbin recently introduced in Congress seek to give the FDA broad new authority to disapprove supplements or supplement ingredients on unknown or arbitrary grounds, with no rules or standards. If allowed to stand, over time this will drastically reduce the number and potency of supplements, raise prices substantially and impair our ability to take care of our own health.
When Congress passed the Dietary Supplement Health and Education Act in 1994, they intended the NDI notification system to be just that: a notification, not a stand-in for a lengthy and complex FDA per-market approval process. DSHEA was written to protect the right of access of consumers to safe dietary supplements. As a consumer who relies on the availability of nutritional supplements for my family's health, I don't want FDA's new guidance to cause my supplements to become unavailable.
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