Another new FDA regulation on dietary supplements

[Guest guest]

The Dietary Supplement and Nonprescription Drug Consumer Protection

Act (P.L. 109-462) was signed into law on 12/22/06 and became

effective on 12/22/07. The law applies to dietary supplements,

defined as a vitamin, herb or other botanical, amino acid, supplement,

concentrate, metabolite, constituent, extract, or any combination of

the above intended for ingestion.

 

The law requires the manufacturer, packer, or distributor (as the

" responsible person " listed on the product label) to provide to the

Food and Drug Administration (FDA) reports of serious adverse events

for dietary supplements marketed within the U.S. There are also

record keeping requirements. If a retailer has their own name on the

label, they may thereby become the responsible person.

 

I've posted a summary of the regulation at

http://www.convergentmedical.com/newsdesk

 

Best regards,

 

David Kailin, Ph.D., M.P.H., L.Ac.

Convergent Medical Systems, Inc.

[Guest guest]

The (corrected) web address should read:

 

I've posted a summary of the regulation at

http://www.convergentmedical.com/newsdesk.html

 

Thanks!

 

d.

[Guest guest]

Just got off the phone with FDA re: severe adverse event reporting

(SAER) requirements in the The Dietary Supplement and Nonprescription

Drug Consumer Protection Act. These clarifications may be of interest

to you.

 

The name on the label of a dietary supplement is (by definition) the

" responsible person " ..unless there is a side agreement transferring

responsibility for SAER.

 

There also needs to be a telephone number or full street address of

the responsible person, printed on the label.

 

If an herbalist custom compounds a formula for a patient,

that product must be labeled per FDA DSHEA & SAER regs.

(Take this unlabeled ziplock of unidentified stuff and call me in the

morning....just doesn't fly.)

 

So the herbalist's name must be on the label of the formulas he custom

compounds (among much other info),

and he is the manufacturer, the distributor, the responsible person

under SAER reporting requirements.

 

The SAER labeling requirements went into effect 12/22/07,

and will actually be enforced by FDA as of 1/1/09.

 

Best regards,

 

d.

 

David Kailin, Ph.D., M.P.H., L.Ac.

Convergent Medical Systems, Inc.

http://www.convergentmedical.com

 

, " convergentmedical "

<kailin wrote:

>

> The Dietary Supplement and Nonprescription Drug Consumer Protection

> Act (P.L. 109-462) was signed into law on 12/22/06 and became

> effective on 12/22/07. The law applies to dietary supplements,

> defined as a vitamin, herb or other botanical, amino acid, supplement,

> concentrate, metabolite, constituent, extract, or any combination of

> the above intended for ingestion.

>

> The law requires the manufacturer, packer, or distributor (as the

> " responsible person " listed on the product label) to provide to the

> Food and Drug Administration (FDA) reports of serious adverse events

> for dietary supplements marketed within the U.S. There are also

> record keeping requirements. If a retailer has their own name on the

> label, they may thereby become the responsible person.

>

> I've posted a summary of the regulation at

> http://www.convergentmedical.com/newsdesk.html

>

> Best regards,

>

> David Kailin, Ph.D., M.P.H., L.Ac.

> Convergent Medical Systems, Inc.

>

[Guest guest]

There was little comment on my posting re: the new FDA

regulations for serious adverse event reporting (SAER) for dietary

supplements. Probably my fault for directing you to my paper on the

topic, rather than explaining the matter in detail here. So I'll have

another go at it, with my apologies in advance if regulatory

discussions bore you to tears...its just that knowing the rules and

choosing to play by them are crucial to staying in the market. If you

are an herbalist, or if you sell dietary supplements, then this

regulation pertains to you.

 

The Dietary Supplement and Nonprescription Drug Consumer

Protection Act (P.L. 109-462) was signed into law on 12/22/06 and

became effective on 12/22/07. The law applies to dietary supplements,

defined as a vitamin, herb or other botanical, amino acid, supplement,

concentrate, metabolite, constituent, extract, or any combination of

the above intended for ingestion.

 

The law requires the manufacturer, packer, or distributor (as the

" responsible person " listed on the product label) to provide to the

Food and Drug Administration (FDA) reports of serious adverse events

for dietary supplements marketed within the U.S. If a retailer's name

is on the label, they are the responsible person for filing such

reports.

 

However, if the retailer has an agreement with the manufacturer

or packer to transfer that responsibility, then the retailer need only

alert the responsible person when the retailer receives a report of a

serious adverse event. If the retailer's name is not on the label, the

retailer should forward reports of serious adverse events to the

responsible person.

 

A serious adverse event is defined as resulting in death,

life-threatening experience, inpatient hospitalization, persistent or

significant disability, congenital anomaly or birth defect, or one

which requires medical intervention to prevent such outcomes.

 

A serious adverse event report (SAER) must have five data

elements: an identifiable injured person; an identifiable initial

reporter; identity and contact information for the responsible person;

identity of the suspect dietary supplement; and identity of the

serious adverse event. A report of a serious adverse event technically

has not been received by a responsible person until all the data

elements have been gathered.

 

The responsible person then has 15 business days to submit a

report by mail to the FDA, using MedWatch Form 3500A. Do not use

MedWatch Form 3500, which is reserved for voluntary reports. A copy

of the label must be included with Form 3500A. The injured person

should not be identified by name on Form 3500A. New medical

information subsequently received by the responsible person must be

forwarded to FDA within 15 business days, with a copy of the

previously submitted Form 3500A.

 

Submission of Form3500A does not constitute admission of causal

or contributory connection between the product and the adverse event.

It would be prudent for the responsible person to include his own

statement to that effect on Form 3500A.

 

Records of serious adverse events - and also non-serious adverse

events - must be maintained for at least 6 years. They may be

inspected by the FDA. Maintain records of Form 3500A submissions, new

medical information and reports of same to FDA, and communications

with the initial reporter and other persons who provided information.

 

The act also has a labeling directive, mandating inclusion of the

phone number (with area code) or full street address of the

responsible person. Optionally, (and preferably, in FDA's eyes) one

may state that it is for serious adverse event reports (and, one might

add, to obtain more info about the product).

 

The act went into effect 12/22/07. All products labeled after

that date should be in compliance. However, the FDA is delaying

enforcement of the labeling requirement until 1/1/2009. You should be

in compliance with severe adverse event reporting now.

 

Now for some ramifications. First of all, if you are an herbalist

who custom compounds formulas for individual patients, then you are

the " responsible person " for those formulas. That is to say, you are

the manufacturer, the distributor, and the retailer, all rolled into one.

 

Second point: all formulas you compound for patients must be

labeled per DSHEA and SAER regulations, just like any other dietary

supplement on a store shelf. (The age of unlabeled little brown paper

packages tied with string is long gone...) The herbalist's name, and

address or phone number, must be on the label (among much additional

info).

 

Third point: context of use defines category of product. If herbs

are labeled and/or the patient is verbally provided with biomedical

treatment indications/claims, it is a drug. If herbs are labeled

and/or provided as a dietary supplement without medicinal

indications/claims, it is a dietary supplement... (unless it contains

otherwise regulated drug products...). So consider labeling and

talking in terms of OM indications (builds yin, etc.), not biomedical

ones.

 

To access FDA Form 3500A: http://www.fda.gov/medwatch/how.htm

To access FDA Draft Guidance:

http://www.cfsan.fda.gov/~dms/dsaergui.html

To access Labeling Draft Guidance:

http://www.cfsan.fda.gov/~dms/dsaergu2.html

 

Best regards,

 

David Kailin, Ph.D., M.P.H., L.Ac.

Author, Quality in Complementary & Alternative Medicine

(This book is now listed on the bibliographies of three NCCAOM

examinations)

http://www.convergentmedical.com

[Guest guest]

David,

Your information is greatly appreciated, especially since you are

doing this basically as a service to the procession. It is to the

point and concise, so all I can really say is thank you for taking the

time to do this.

 

I remember you from the Seattle macrobiotic community some three

decades ago. .

 

 

 

On Feb 21, 2008, at 2:29 PM, convergentmedical wrote:

 

> There was little comment on my posting re: the new FDA

> regulations for serious adverse event reporting (SAER) for dietary

> supplements. Probably my fault for directing you to my paper on the

> topic, rather than explaining the matter in detail here. So I'll have

> another go at it, with my apologies in advance if regulatory

> discussions bore you to tears...its just that knowing the rules and

> choosing to play by them are crucial to staying in the market. If you

> are an herbalist, or if you sell dietary supplements, then this

> regulation pertains to you.

>

> The Dietary Supplement and Nonprescription Drug Consumer

> Protection Act (P.L. 109-462) was signed into law on 12/22/06 and

> became effective on 12/22/07. The law applies to dietary supplements,

> defined as a vitamin, herb or other botanical, amino acid, supplement,

> concentrate, metabolite, constituent, extract, or any combination of

> the above intended for ingestion.

>

> The law requires the manufacturer, packer, or distributor (as the

> " responsible person " listed on the product label) to provide to the

> Food and Drug Administration (FDA) reports of serious adverse events

> for dietary supplements marketed within the U.S. If a retailer's name

> is on the label, they are the responsible person for filing such

> reports.

>

> However, if the retailer has an agreement with the manufacturer

> or packer to transfer that responsibility, then the retailer need only

> alert the responsible person when the retailer receives a report of a

> serious adverse event. If the retailer's name is not on the label, the

> retailer should forward reports of serious adverse events to the

> responsible person.

>

> A serious adverse event is defined as resulting in death,

> life-threatening experience, inpatient hospitalization, persistent or

> significant disability, congenital anomaly or birth defect, or one

> which requires medical intervention to prevent such outcomes.

>

> A serious adverse event report (SAER) must have five data

> elements: an identifiable injured person; an identifiable initial

> reporter; identity and contact information for the responsible person;

> identity of the suspect dietary supplement; and identity of the

> serious adverse event. A report of a serious adverse event technically

> has not been received by a responsible person until all the data

> elements have been gathered.

>

> The responsible person then has 15 business days to submit a

> report by mail to the FDA, using MedWatch Form 3500A. Do not use

> MedWatch Form 3500, which is reserved for voluntary reports. A copy

> of the label must be included with Form 3500A. The injured person

> should not be identified by name on Form 3500A. New medical

> information subsequently received by the responsible person must be

> forwarded to FDA within 15 business days, with a copy of the

> previously submitted Form 3500A.

>

> Submission of Form3500A does not constitute admission of causal

> or contributory connection between the product and the adverse event.

> It would be prudent for the responsible person to include his own

> statement to that effect on Form 3500A.

>

> Records of serious adverse events - and also non-serious adverse

> events - must be maintained for at least 6 years. They may be

> inspected by the FDA. Maintain records of Form 3500A submissions, new

> medical information and reports of same to FDA, and communications

> with the initial reporter and other persons who provided information.

>

> The act also has a labeling directive, mandating inclusion of the

> phone number (with area code) or full street address of the

> responsible person. Optionally, (and preferably, in FDA's eyes) one

> may state that it is for serious adverse event reports (and, one might

> add, to obtain more info about the product).

>

> The act went into effect 12/22/07. All products labeled after

> that date should be in compliance. However, the FDA is delaying

> enforcement of the labeling requirement until 1/1/2009. You should be

> in compliance with severe adverse event reporting now.

>

> Now for some ramifications. First of all, if you are an herbalist

> who custom compounds formulas for individual patients, then you are

> the " responsible person " for those formulas. That is to say, you are

> the manufacturer, the distributor, and the retailer, all rolled into

> one.

>

> Second point: all formulas you compound for patients must be

> labeled per DSHEA and SAER regulations, just like any other dietary

> supplement on a store shelf. (The age of unlabeled little brown paper

> packages tied with string is long gone...) The herbalist's name, and

> address or phone number, must be on the label (among much additional

> info).

>

> Third point: context of use defines category of product. If herbs

> are labeled and/or the patient is verbally provided with biomedical

> treatment indications/claims, it is a drug. If herbs are labeled

> and/or provided as a dietary supplement without medicinal

> indications/claims, it is a dietary supplement... (unless it contains

> otherwise regulated drug products...). So consider labeling and

> talking in terms of OM indications (builds yin, etc.), not biomedical

> ones.

>

> To access FDA Form 3500A: http://www.fda.gov/medwatch/how.htm

> To access FDA Draft Guidance:

> http://www.cfsan.fda.gov/~dms/dsaergui.html

> To access Labeling Draft Guidance:

> http://www.cfsan.fda.gov/~dms/dsaergu2.html

>

> Best regards,

>

> David Kailin, Ph.D., M.P.H., L.Ac.

> Author, Quality in Complementary & Alternative Medicine

> (This book is now listed on the bibliographies of three NCCAOM

> examinations)

> http://www.convergentmedical.com

>

>

>

 

 

Chair, Department of Herbal Medicine

Pacific College of Oriental Medicine

San Diego, Ca. 92122