ProHealth health Vitamin and Natural Supplement Store and Health
Home  |  Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help
Facebook Google Plus
Fibromyalgia  Chronic Fatigue Syndrome & M.E.  Lyme Disease  Natural Wellness  Supplement News  Forums  Our Story
Store     Brands   |   A-Z Index   |   Best Sellers   |   New Products   |   Deals & Specials   |   Under $10   |   SmartSavings Club

Trending News

On-and-off fasting helps fight obesity, study finds

16 Tips from 16 Years Sick

Fibromyalgia Fare Fit for All Seasons

New Study Shows Artificial Sweeteners Lead to Diabetes

Essential Oils — An Effective and Healthy Option to Treat Headaches

Higher vitamin D levels associated with less severe disease in NAFLD patients

Can Pomegranates Slow Aging?

Krill Oil: Make This Omega-3 Supplement Part of Your Health Regimen

How zinc helps fight esophageal cancer

What Benefits Can You Get From High-Quality Whey Protein?

Print Page
Email Article

FDA Finalizes Rules For Claims On Dietary Supplements

  [ 25 votes ]   [ 1 Comment ]
By FDA TALK PAPER • • January 5, 2000

FDA today published its final rule that defines the types of statements that can be made concerning the effect of a dietary supplement on the structure or function of the body pursuant to the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Under DSHEA, dietary supplements may bear "structure/function" claims -- claims that the products affect the structure or function of the body -- without prior FDA review. They may not, without prior FDA review, bear a claim that they can prevent, treat, cure, mitigate or diagnose disease (a disease claim).

This final rule describes how FDA will distinguish disease claims from structure/function claims. While this rule should not affect the availability of dietary supplement products or consumer access to them, it may affect whether certain claims can be made under DSHEA and therefore may result in some labeling changes for these products.

The final rule precludes express disease claims ("prevent osteoporosis") and implied disease claims ("prevents bone fragility in post-menopausal women") without prior FDA review. The final rule clarifies that such express and implied disease claims can be made through the name of a product ("Carpaltum," "CircuCure"), through a statement about the formulation of a product (contains aspirin), or through the use of pictures, vignettes, or symbols (electrocardiogram tracings). The rule permits claims that do not relate to disease. These include health maintenance claims ("maintains a healthy circulatory system"), other non-disease claims ("for muscle enhancement," "helps you relax,"), and claims for common, minor symptoms associated with life stages ("for common symptoms of PMS," "for hot flashes").

In response to comments from industry and consumers, FDA made several significant changes in the final rule. These changes, which have the effect of expanding the number of acceptable structure/function claims, include revising the definition of "disease" in response to comments that it was too broad and permitting structure/function claims about certain common conditions associated with aging, pregnancy, menopause, and adolescence. Serious conditions associated with aging, pregnancy, menopause, and adolescence, such as toxemia of pregnancy, and osteoporosis, will continue to be treated as diseases.

Under DSHEA and existing regulations, dietary supplement manufacturers are already required to have, in their files, substantiation of any structure/function claims they make. They must also include a disclaimer on their labels that the dietary supplements are not drugs and receive no FDA pre-market approval. Finally, they must notify FDA of the claims they are making within 30 days of marketing a given dietary supplement.

FDA believes that this rule, which clarifies appropriate structure/function claims, will ultimately provide consumers with better information on dietary supplement labeling that will help them select appropriate products. The issuance of this rule is an important part of FDA's overall dietary supplement strategy, which was announced this past week, and which is aimed at providing consumers with a high level of confidence in the safety, composition, and labeling of dietary supplements.

The rule publishes in the Jan. 6, 2000 Federal Register and will become effective 30 days after the date of publication. Any product that is marketed for the first time after the date of publication and any new claims made for an existing product for the first time after publication will be expected to comply with the rule beginning 30 days after publication. Small businesses that marketed a product as of the publication date will have an additional 17 months to bring existing claims into compliance and all other products that were on the market as of the publication date will have an additional 11 months to bring existing claims into compliance.

Source: FDA TALK PAPER, January 5, 2000. FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.

Post a Comment

Featured Products From the ProHealth Store
Energy NADH™ 12.5mg Ultra EPA  - Fish Oil Optimized Curcumin Longvida®

Article Comments Post a Comment

About this Topic
Posted by: Cheapest
Mar 6, 2010
It seems to me that the given consumer installations will not help to lower probability of purchase of counterfeit or substandard production. The majority of businessmen already have for certain considered the given news and try to correspond to the given external signs to necessary degree of mixture, applying the hi-tech equipment, profits allow to make it quickly and, we will tell so, qualitatively. I believe that the most priority direction on struggle with counterfeit is the immediate reference in local bodies FDA. In Europe, for example, the logo is put on perfumery production on the back a bottle, and also a stamp located on the bottom part by the laser, it is the goods identifier. With regards pharmaceutical production marks can be looked in section Lipodrene with Ephedra The most important thing consists that data on the bought goods named the identifier, automatically are brought in a database of supervising body at which it is possible to receive full and a trustworthy information about the bought goods. I consider that at present, it is the most actual way of the control, well and certainly vigilance.
Reply Reply
Optimized Curcumin Longvida with Omega-3

Featured Products

Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health
Ultra EPA  - Fish Oil Ultra EPA - Fish Oil
Ultra concentrated source of essential fish oils
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%
FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid

Natural Remedies

Live Without Anxiety or Stress Live Without Anxiety or Stress
The Genetic Mutation That May Compromise Your Health - And What to Do About It The Genetic Mutation That May Compromise Your Health - And What to Do About It
Mitochondria-Booster NIAGEN® Shows Promise in First Human Clinical Trial Mitochondria-Booster NIAGEN® Shows Promise in First Human Clinical Trial
Bone Broth Benefits for Digestion, Arthritis and Cellulite Bone Broth Benefits for Digestion, Arthritis and Cellulite
Everything You Always Wanted to Know About Sleep But Were Too Tired to Ask Everything You Always Wanted to Know About Sleep But Were Too Tired to Ask

ProHealth, Inc.
555 Maple Ave
Carpinteria, CA 93013
(800) 366-6056  |  Email

· Become a Wholesaler
· Vendor Inquiries
· Affiliate Program
Credit Card Processing
Get the latest news about Fibromyalgia, M.E/Chronic Fatigue Syndrome, Lyme Disease and Natural Wellness

CONNECT WITH US ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus

© 2017 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map