The growing concerns about nutraceuticals have led to industry self-regulation to prevent government intervention. Learn what the industry is doing.

1. The Growing
Concerns
about
Nutraceuticals

2. United States Healthcare is
Changing
 Patients participate more in the
treatments
 Surgery and pharmaceutical drugs are
less popular
 People are choosing their own
treatments

3. Patients Choices
 Alternativenatural foods
 Dietary supplements
 Preventive supplementary
approaches

4. Things Have Changed
 Dietary supplements are not as strict
as pharmaceutical ones
 Dietary Supplement Health and
Education Act (DSHEA) removed
control from the FDA
◦ Removed the oversight of dietary
supplements

5. Things Have Changed
 Dietary supplements not promoted as
substitution for pharmaceutical
 FDA guidelines don’t apply to dietary
supplements

6. Inadequate Information
 Uncertainty surrounding the packaging
and advertising of nutraceuticals
 Growing concerns among consumers
and professionals in the industry
 Not enough information about the
quality and proper usage

7. Learning More
 Healthcare professionals seek to keep
their training up to date
 Continuing medical education (CME)
provides learning programs and
conferences
 Awareness that nutraceuticals have
not been properly monitored
 Not much is known about how
ingredients are processed and grown

8. Not up to Par
 No trials or studies are conducted on
them
 Question arise
◦ Are they safe?
◦ What are true benefits?
 Manufactures extravagate benefits
due to early study results

9. Many Differences
 FDA regulates use of certain
ingredients such as ephedrine
 No guidelines for what can and can’t
be put in nutraceuticals
◦ Ephedrine often appears

10. More then Meets the Eye
 Belief is that dietary supplements have
less side effects
 Doctors beginning to recommend
nutraceuticals along with drugs
 Customers wonder about an
agreement between doctors and
manufacturers

11. Problem Solving
 The American Nutraceutical
Association is interacting with the FDA
to resolve problems
 Manufactures want information about
nutraceuticals to be correct
 Do not want more regulation

12. Compliance Experts
 Compliance Insight, Inc.
 Your Hands-On Quality and Regulatory Specialists
 Our services include GMP consulting, audit
preparation, FDA mock inspections, FDA response
assistance, vendor/contract audits, GMP training and
accreditation, new construction compliance, regulatory
consulting, investigations, biosafety and viral testing
consulting; clinical trial audits and more.
 For more information visit http://compliance-
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