new book on Regulations

[Guest guest]

New Book:

http://www.naturalproductsinsider.com/news/2011/11/book-covers-u-s-suppl

ement-regs.aspx

WASHINGTON-A new book offers an overview of dietary supplement federal

regulations to help the increasing number of stakeholders-from marketers

of vitamins and minerals to pharmaceutical and food

manufacturers-navigate through U.S. FDA, FTC and DEA laws that affect

the natural products market.

The book, " Dietary Supplement Regulation: A Comprehensive Guide, " edited

by Bass, partner at Sidley Austin in Washington, was published by

The Food and Drug Law Institute <http://www.fdli.org/> . In the book,

Bass, who serves as the chief counsel for the Natural Products

Association <http://www.npainfo.org/> (NPA), explains dietary

supplement regulatory issues including regulatory status and

formulation, product claims and intended use, dietary supplement

marketing and safety, GMPs (good manufacturing practices), and foreign

regulation.

Appendices include:

* The Dietary Supplement Health and Education Act of 1994

<http://www.naturalproductsinsider.com/topics/dshea.aspx> (DSHEA);

* Congressional " Statement of Agreement " on DSHEA;

* Relevant portions of FDA's Modernization Act of 1997;

* Dietary Supplement and Nonprescription Drug Consumer

Protection Act;

* Relevant portions of FDA's Amendments Act of 2007;

* Relevant portions of the FDA Food Safety Modernization Act;

* FDA Final Rule: Dietary Supplement Statements Re:

Structure/Function;

* FDA Final Rule: Premarket Notification for a New Dietary

Ingredient

<http://www.naturalproductsinsider.com/new-dietary-ingredients.aspx>

(NDI);

* Draft Guidance for Industry: Dietary Supplements: New Dietary

Ingredient Notifications and Related Issues;

* Guidance for Industry: questions and answers regarding adverse

event reporting and recordkeeping for dietary supplements as required by

the Dietary Supplement and Nonprescription Drug Consumer Protection Act;

* Guidance for Industry: Current Good Manufacturing Practice in

Manufacturing, Packaging, Labeling or Holding Operations for Dietary

Supplements;

* Small Entity Compliance Guide; and

* Federal Trade Commission: Dietary Supplements: An Advertising

Guide for Industry.

" The Natural Products Association is pleased that the Food and Drug Law

Institute has teamed up with Bass and Sidley Austin to offer a

powerful new resource for the dietary supplement industry, " said

Gay, NPA

<http://www.naturalproductsinsider.com/topics/natural-products-associati

on.aspx> executive director and CEO. " is a pioneer in the industry

whose work on protecting supplement makers from onerous regulations is

second to none. "

Bass heads Sidley Austin LLP's global life sciences team, coordinating

pharmaceutical, medical device, food and dietary supplement matters in

the United States, Europe and Asia. He is ranked internationally among

the top authorities on FDA-related enforcement and regulatory issues,

and has led audits and investigations involving off-label promotion,

pharmacovigilance, the Prescription Drug Marketing Act (PDMA), GMP and

fraud and abuse issues, as well DEA and FTC matters. He was a major

contributor to the drafting of DSHEA, and has given presentations on the

NDI Draft Guidance

<http://www.naturalproductsinsider.com/news/2011/06/npa-webinar-discusse

s-new-ndi-guidance.aspx> .

FDLI, founded in 1949, is a nonprofit organization that provides a

marketplace for discussing food and drug law issues through conferences,

publications and member interaction. FDLI's scope includes food, drugs,

animal drugs, biologics, cosmetics, diagnostics, dietary supplements and

medical devices. FDLI recently held a conference

<http://www.naturalproductsinsider.com/news/2011/03/conference-discusses

-u-s-china-import-regs.aspx> addressing various laws and policies that

govern the food, cosmetic, drug and medical device industry in the

United States and in China.

S. Kalman PhD, RD, FACN

Director, BD - Nutrition & Applied Clinical Trials

Miami Research Associates

6141 Sunset Drive

Suite 301

Miami, FL. 33143

Direct -

Office ext. 5109

Fax

Email: dkalman@...

Web: www.miamiresearch.com

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