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The FDA Is Threatening All Supplement Innovations — YOU CAN ACT RIGHT NOW TO STOP THIS

December 1, 2011

Please, Read this:

The FDA Is Threatening All Supplement Innovations Since 1994
We need to ACT IMMEDIATELY! DEADLINE IS DECEMBER 2, 2011 – The FDA is proposing certain
regulations to impede, restrict, and ban dietary supplements – natural plant extracts, herbal formulas,
probiotics, etc. are all affected. Variations of these regulations have already been enforced in Europe
and other countries -DO NOT LET IT HAPPEN HERE. SEND a letter BELOW and RESPOND to the
FDA TODAY! TELL THE FDA TO RETRACT THE NDI – NEW DIETARY INGREDIENT REGULATIONS!

This is not the first time that the FDA has proposed bills to ban natural supplements. This type of
legislation will continue to arise, and we must continue to oppose it. We have the right to choose an
alternative and natural solution for our health.

Thank you for your support in the past and your continued support for natural products such as Sacred Chocolate.

Just Follow These 3 Steps – General letters won’t work this time:

Fax your letter to Beth Clay, our liaison in DC, at 202-318-7557 and she will bundle them and get them
to the FDA. Or go online and submit your letters directly on the
website- http://www.regulations.gov/#!home.

STEPS: See the sample letter below – edit and choose to your liking and emphasis. Cut and paste
sections. DO NOT SEND THE ENTIRE LETTER AS PRESENTED.

#1: Copy the basic beginning and end text into your letter.

#2: Copy the points of concern you like – cut and paste into your letter (see below).

#3: Fax your letter to Beth Clay, our liaison in DC:
202-318-755 (Beth will bundle them and get them to the FDA) Or:
Submit your letters directly online: http://www.regulations.gov/#!home.

For a sample, see below!

THIS IS A REALLY BIG DEAL. STAY WITH US HERE

THE SAMPLE LETTER AND POINTS:

Dec 1, 2011

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

RE: Draft Guidance for Industry; Dietary Supplements New Dietary Ingredient Notifications and
Related Issues (FDA Docket No: 2011-D-0376)

Dear Sir or Madam:

I submit the following comments to the Record on FDA Docket No: 2011-D-0376.

While Congress asked that the FDA clarify the existing New Dietary Ingredient (NDI) regulation
established in 1997 as a result of the 1994 Dietary Supplement Health and Education Act (DSHEA), the
draft Guide Document is fatally flawed and needs to be retracted in its entirety. The following points are a
few of my concerns:

( PLACE / INSERT POINTS OF CONCERN HERE )

This guidance document if finalized as written will have a number of far-reaching effects on industry and the
marketplace.

Consumers, like my family, and me are not well served by the resulting higher prices and reduction in some
products in the market that surely will follow if industry is forced to comply with these overburdened proposed
procedures.

As such, I call for the FDA to retract this draft NDI Guidance document in its entirety and craft a simpler, more
appropriate guidance document in coordination with the industry and interested citizens.

Signed:
Name:
Address:

*************************************************************

INSERT ABOVE THE FOLLOWING POINTS YOU LIKE:
• The extensive 86 page with than 50 attachments NDI Guidance document is an attempt at "Rulemaking by
Guidance Document" which is forbidden by federal law. It encroaches on the legislative and legal authority.

• The document proposes protocols that will result in higher consumer prices for supplements.

• Congress did not intend the guidance to be more limiting than the existing rule or to create "unreasonable
regulatory barriers" which this, if finalized in its current form, would certainly do.

• Throughout the draft guidance document, the FDA is setting the stage to pull the dietary supplement
regulations closer to the drug regulations model, which is in conflict with the will of the American people and
current law through DSHEA.

• The NDI Guidance document, if implemented as written, broadens the NDI scope of definitions and would
create significant new burdens on the industry for any "new" dietary supplement, "new" meaning retroactive
inclusion of 90% of the dietary supplements on the market today.

• These regulations will create many barriers for innovations in the Dietary Supplement industry and, in
particular, deter smaller companies with fewer resources from protecting their formulas, ensuring a fair market
share because of pre-market approvals and conducting more research than is actually necessary.

• The end result of passage of these regulations is limiting access by consumers, especially those with limited
financial means, to quality products and adequate dosages without prescriptions and putting health care out of
reach for many. This has happened in Europe and other countries and I do not want this to happen in the United
States.

• The entire premise from which the FDA crafts this draft guidance document is fatally flawed from the fundamental
crafty framing to herd supplements made from food into drug categories to an assumption that there is a problem
in nature that has to be solved, to a focus on specific definitions and sections of the DSHEA to support its big
pharmaceutical and big chemical company leanings in lieu of fair and balanced policy making principles for everyone.

• There appears to be an underlying attempt to create rules that regulate food-based nutritional supplements as if
they were toxins, which not only restricts our abilities to choose natural approaches to health, but, represents a
rejection of the entire history of human experience with nature and its life affirming nutrients.

• The FDA is creating significant burdens on both industry and the agency itself by proposing that an NDI notification
will likely be needed for every product in since 1994 and any with a slight variation or modification.

• The FDA has erroneously limited the "marketplace" language of DSHEA to mean only the marketplace of the United
States. This is not what Congress stated; this is not a fair policy for the American supplement industry.

• There are likely products in the marketplace today that, if this guidance document is finalized as written, could lead
to adulteration notifications on products that contain ingredients that were in the food supply in 1994, but were not
confirmed to be in dietary supplements prior to the grandfathering in date.

• Products that contain ingredients marketed in supplements outside the United States, but not in the US, may be at
risk for an adulteration NDI notification also with extreme and costly measures of proof at stake. Yet, there is no way
to control foreign manufacturing processes or formulation – an excellent example being vitamin C where 90% of it is
synthetic and comes from China.

• Products with probiotics may be eliminated from the marketplace under the provisions of the NDI Guidance Document.
This has a special bleed through even to large industries where many types of chemicals are used similar to fertilizing
in the beginning of the fermentation process yet never reported, labeled, or monitored. Transparence for one is
transparency for all.

• The FDA’s proposed guidance document would trigger significant new NDI submissions when manufacturer
processes are innovated or modernized from this date forward, as well as those from the past from 1994.
Changes in manufacturing procedures or formulas trigger the need for an NDI Notice.

• Using a different part of a plant will require an NDI notification. Using a plant or herb at a different stage of
maturation could trigger an NDI notification requirement.

• Heating up or baking ingredients could require an NDI notification as well any variations in temperature at
different stages.

• Changing the agricultural or fermentation conditions of the ingredients (such as sprouting or using a medium
such as sodium selenite) could trigger an NDI notification requirement.

• Drug Research May Keep Products Out of Dietary Supplements: The FDA’s current thinking on when a dietary
ingredient is barred from being marketed as a dietary supplement is impractical on its face and would limit
access to ingredients simply because a pharmaceutical company is considering drug development.

• The FDA suggests that a Citizen’s Petition would be required to market a dietary ingredient that has been part
of a drug development program but is no longer being studied.

• The current thinking is that an article that has been authorized for investigation as a new drug or as a biologic
before being marketed as a food or dietary supplement cannot be marketed as a dietary supplement if
substantial clinical investigations of the article have begun and the existence of such investigations have been
made public.

• A dietary ingredient could be barred from being marketed as a dietary supplement if the drug industry is
researching a component of the ingredient as an investigational new drug under IND.

• The draft guidance document is in conflict with the following provision of DSHEA: "…the Federal Government
should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe
products and accurate information to consumers…" and thus should be retracted in its entirety.

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The FDA Is Threatening All Supplement Innovations — YOU CAN ACT RIGHT NOW TO STOP THIS

December 1, 2011

Please, Read this:

The FDA Is Threatening All Supplement Innovations Since 1994
We need to ACT IMMEDIATELY! DEADLINE IS DECEMBER 2, 2011 – The FDA is proposing certain
regulations to impede, restrict, and ban dietary supplements – natural plant extracts, herbal formulas,
probiotics, etc. are all affected. Variations of these regulations have already been enforced in Europe
and other countries -DO NOT LET IT HAPPEN HERE. SEND a letter BELOW and RESPOND to the
FDA TODAY! TELL THE FDA TO RETRACT THE NDI – NEW DIETARY INGREDIENT REGULATIONS!

This is not the first time that the FDA has proposed bills to ban natural supplements. This type of
legislation will continue to arise, and we must continue to oppose it. We have the right to choose an
alternative and natural solution for our health.

Thank you for your support in the past and your continued support for natural products such as Sacred Chocolate.

Just Follow These 3 Steps – General letters won’t work this time:

Fax your letter to Beth Clay, our liaison in DC, at 202-318-7557 and she will bundle them and get them
to the FDA. Or go online and submit your letters directly on the
website- http://www.regulations.gov/#!home.

STEPS: See the sample letter below – edit and choose to your liking and emphasis. Cut and paste
sections. DO NOT SEND THE ENTIRE LETTER AS PRESENTED.

#1: Copy the basic beginning and end text into your letter.

#2: Copy the points of concern you like – cut and paste into your letter (see below).

#3: Fax your letter to Beth Clay, our liaison in DC:
202-318-755 (Beth will bundle them and get them to the FDA) Or:
Submit your letters directly online: http://www.regulations.gov/#!home.

For a sample, see below!

THIS IS A REALLY BIG DEAL. STAY WITH US HERE

THE SAMPLE LETTER AND POINTS:

Dec 1, 2011

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

RE: Draft Guidance for Industry; Dietary Supplements New Dietary Ingredient Notifications and
Related Issues (FDA Docket No: 2011-D-0376)

Dear Sir or Madam:

I submit the following comments to the Record on FDA Docket No: 2011-D-0376.

While Congress asked that the FDA clarify the existing New Dietary Ingredient (NDI) regulation
established in 1997 as a result of the 1994 Dietary Supplement Health and Education Act (DSHEA), the
draft Guide Document is fatally flawed and needs to be retracted in its entirety. The following points are a
few of my concerns:

( PLACE / INSERT POINTS OF CONCERN HERE )

This guidance document if finalized as written will have a number of far-reaching effects on industry and the
marketplace.

Consumers, like my family, and me are not well served by the resulting higher prices and reduction in some
products in the market that surely will follow if industry is forced to comply with these overburdened proposed
procedures.

As such, I call for the FDA to retract this draft NDI Guidance document in its entirety and craft a simpler, more
appropriate guidance document in coordination with the industry and interested citizens.

Signed:
Name:
Address:

*************************************************************

INSERT ABOVE THE FOLLOWING POINTS YOU LIKE:
• The extensive 86 page with than 50 attachments NDI Guidance document is an attempt at "Rulemaking by
Guidance Document" which is forbidden by federal law. It encroaches on the legislative and legal authority.

• The document proposes protocols that will result in higher consumer prices for supplements.

• Congress did not intend the guidance to be more limiting than the existing rule or to create "unreasonable
regulatory barriers" which this, if finalized in its current form, would certainly do.

• Throughout the draft guidance document, the FDA is setting the stage to pull the dietary supplement
regulations closer to the drug regulations model, which is in conflict with the will of the American people and
current law through DSHEA.

• The NDI Guidance document, if implemented as written, broadens the NDI scope of definitions and would
create significant new burdens on the industry for any "new" dietary supplement, "new" meaning retroactive
inclusion of 90% of the dietary supplements on the market today.

• These regulations will create many barriers for innovations in the Dietary Supplement industry and, in
particular, deter smaller companies with fewer resources from protecting their formulas, ensuring a fair market
share because of pre-market approvals and conducting more research than is actually necessary.

• The end result of passage of these regulations is limiting access by consumers, especially those with limited
financial means, to quality products and adequate dosages without prescriptions and putting health care out of
reach for many. This has happened in Europe and other countries and I do not want this to happen in the United
States.

• The entire premise from which the FDA crafts this draft guidance document is fatally flawed from the fundamental
crafty framing to herd supplements made from food into drug categories to an assumption that there is a problem
in nature that has to be solved, to a focus on specific definitions and sections of the DSHEA to support its big
pharmaceutical and big chemical company leanings in lieu of fair and balanced policy making principles for everyone.

• There appears to be an underlying attempt to create rules that regulate food-based nutritional supplements as if
they were toxins, which not only restricts our abilities to choose natural approaches to health, but, represents a
rejection of the entire history of human experience with nature and its life affirming nutrients.

• The FDA is creating significant burdens on both industry and the agency itself by proposing that an NDI notification
will likely be needed for every product in since 1994 and any with a slight variation or modification.

• The FDA has erroneously limited the "marketplace" language of DSHEA to mean only the marketplace of the United
States. This is not what Congress stated; this is not a fair policy for the American supplement industry.

• There are likely products in the marketplace today that, if this guidance document is finalized as written, could lead
to adulteration notifications on products that contain ingredients that were in the food supply in 1994, but were not
confirmed to be in dietary supplements prior to the grandfathering in date.

• Products that contain ingredients marketed in supplements outside the United States, but not in the US, may be at
risk for an adulteration NDI notification also with extreme and costly measures of proof at stake. Yet, there is no way
to control foreign manufacturing processes or formulation – an excellent example being vitamin C where 90% of it is
synthetic and comes from China.

• Products with probiotics may be eliminated from the marketplace under the provisions of the NDI Guidance Document.
This has a special bleed through even to large industries where many types of chemicals are used similar to fertilizing
in the beginning of the fermentation process yet never reported, labeled, or monitored. Transparence for one is
transparency for all.

• The FDA’s proposed guidance document would trigger significant new NDI submissions when manufacturer
processes are innovated or modernized from this date forward, as well as those from the past from 1994.
Changes in manufacturing procedures or formulas trigger the need for an NDI Notice.

• Using a different part of a plant will require an NDI notification. Using a plant or herb at a different stage of
maturation could trigger an NDI notification requirement.

• Heating up or baking ingredients could require an NDI notification as well any variations in temperature at
different stages.

• Changing the agricultural or fermentation conditions of the ingredients (such as sprouting or using a medium
such as sodium selenite) could trigger an NDI notification requirement.

• Drug Research May Keep Products Out of Dietary Supplements: The FDA’s current thinking on when a dietary
ingredient is barred from being marketed as a dietary supplement is impractical on its face and would limit
access to ingredients simply because a pharmaceutical company is considering drug development.

• The FDA suggests that a Citizen’s Petition would be required to market a dietary ingredient that has been part
of a drug development program but is no longer being studied.

• The current thinking is that an article that has been authorized for investigation as a new drug or as a biologic
before being marketed as a food or dietary supplement cannot be marketed as a dietary supplement if
substantial clinical investigations of the article have begun and the existence of such investigations have been
made public.

• A dietary ingredient could be barred from being marketed as a dietary supplement if the drug industry is
researching a component of the ingredient as an investigational new drug under IND.

• The draft guidance document is in conflict with the following provision of DSHEA: "…the Federal Government
should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe
products and accurate information to consumers…" and thus should be retracted in its entirety.

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