Another new FDA regulation of dietary supplements

[Guest guest]

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

this new FDA 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 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