An Introduction to the Supplement Industry
What You Think You Know vs. The Reality Of the Industry
What You Think You Know vs. The Reality Of the Industry
Let me start off by saying ” Your Welcome!” . Why? you may ask? Because This may open your eyes to some of the common misconceptions about this topic. That being said I use and have used Supplements and have no problem whether you do or do not, but if you decide to I want you to be able to find all the information you need without having to search all through the internet.
I will do that for you, right here and right now.
Below will consist of:
History of Dietary Supplements
Key Components of the Regulations for Dietary Supplements
My Summary
Here is one reason for the article series The FDA’s Attempt to make new regulations.
I will save you the read and by pulling these excerpts from the article above:
“To expand its current $28-billion-a-year market, the dietary supplements industry is widely devising and selling formulations that use “novel” products — minerals, plants, or amino acids that appear newly promising, which have not circulated widely in the United States before, or which are offered in “mega-doses” much higher than have been customarily used in supplements. An industry that produced and marketed 4,000 distinct products in 1994, when the regulatory framework for dietary supplements was written into law, now markets about 55,000 products to Americans who believe them to be safe to take.
The new rules aim to spell out how a “reasonable expectation of safety” should be established. In some cases, the agency would accept documentation of a supplement’s “historical use” outside the United States. For “mega-doses” that exceed commonly used levels of a given supplement, the agency wants to see evidence of safety from animal studies and from test-tube studies. (While trials using human subjects in testing a supplement’s long-term use are allowed, they’re not required).”
NOW FOR THE BRIEF HISTORY AND BACKGROUND INFORMATION:
-Supplements are considered under the umbrella term of food and not a Drug. KEEP READING
-Regulations differ throughout the world and not all are comparable to the regulations used here in the US.
-1906: The Pure Food and Drug Act dealt with unsafe foods, unregulated elixirs, and misbranded products
-1938: The Federal Food, Drug, and Cosmetic Act established a category of foods for special dietary use and required the labels of such foods
-1941: The FDA established regulations for the minimum daily requirement (MDR) to express a daily need for the nutrients.
-1976: Congress passes regulates no longer considering vitamins and minerals as drugs no matter their concentration or amount.
-1990: Congress passes the National Labeling and Education Act which required specific nutritional and ingredient information
-1992: Congress passed the Dietary Supplement Act which essentially prohibited the implementation of NLEA with respect to dietary supplements except for the approved health claims
The Dietary Supplement Health and Education Act of 1994 (DSHEA)
(Since it’s passing there have a been some revisions from the original Act)
– The Only overruling authority over the Supplement Industry which allowed for the formation of Office of Dietary Supplements through the National Institutes of Health
-ODS is directed by the DSHEA to conduct and coordinate scientific research relating to dietary supplements within NIH
– The DSHEA defines what is considered a supplement (everything from your daily vitamin, holistic/”natural meds”. to the illegal anabolic steroids etc.)
a vitamin
a mineral
an herb or other botanical
an amino acid
a dietary substance for use by “man” to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands)
a concentrate, metabolite, constituent or extract.
-An ingredient used before the act was passed in 1994 must be cleared and approved by the manufacturer showing the ingredient was used in the past and “will reasonably be expected to be safe.” and does not have any required documentation of proof of safety when submitted.
– Requires studies and tests from the manufactures proving their claims are accurate. But does not regulate how and by who the studies are conducted of funded.
–Publications aiding in sales such as “scientific studies” used to promote the products are not under the classifications of labeling because those original studies were not intended for interpretation by the consumer market.
-The Federal Trade Commission Regulates the Advertising of the Products.
-The FDA oversees and regulates product labeling and is allowed to report any issues that a product might have while on the market
This label must identify each dietary ingredient contained in the product active or inactive.
any claims to prevent, treat, or cure a specific disease is not allowed(ex. Cures cancer, prevents joint pain, treats migraines etc.)
However they can say it helps with nutrient deficient diseases and using the words “maintains”, “promotes” ‘well-being”, “good healthy…” as long as stated not approved by FDA. (Which can be misleading to some uninformed consumers)
-Both the U.S. Pharmacopeia (USP) and Consumer Labs (CL) are independent, non-regulatory bodies that serve to verify that a product is free from contaminants, accurate in its ingredient labeling and manufactured using sound practices. But their seal of approval does not provide evidence of safety.
THE FDA’s ROLE and Limitations Under the DSHEA
-“This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” must be on all labels.
– The FDA will Publicly report and warn if they suspect a product is unsafe.
-As Consumers you are allowed to file a complaint or better called “Adverse Event Reporting”
–Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements to the public.
–The agency does not regularly analyze dietary supplements before they are sold to consumers.
– They do not analyze the content of the supplements unless they have shown prior instance of being unsafe.
– Manufacturers or distributors of dietary supplements do not have to tell FDA or consumers what evidence they have about their product’s safety or what evidence they have to back up the claims they are making for them.
– FDA is NOT authorized to “:approve, certify, license or approve individual food importers, products, labels or shipments. Importers can import into the US without prior approval by FDA, as long as the facilities that produce, store or otherwise handle the products are registered with FDA, and prior notice of incoming shipments is provided to FDA.”
– Regulates the use of only legal ingredients in their products to the best of their ability under their power as a food regulatory agency
-Manufacturers must notify the FDA of nutritional label statements no later than 30 days after the product is first marketed.
–Validity of the product solely rests on the claims of the Manufacturer and Distributor of the product
MY SUMMARY:
ALL OF THAT BEING SAID I FEEL THERE IS STILL SOME REGULATORY IMPROVEMENTS THAT COULD BE MADE IN ORDER TO ENSURE THE PRODUCTS ARE SAFE FROM START TO FINISH. THERE ARE SOME NATRUAL HEALTH ORGANIZATIONS THAT THINK THINGS ARE PERFECTLY FINE WITH THE REGULATIONS, AND SOME OTHERS WOULD LIKE LESS GOVERNMENTAL AGENCY CONTROL(FDA).
THEY COULD BE RIGHT IN SOME ASPECTS BUT I THINK THAT BETTER REGULATIONS WILL HELP FREE THE MARKET OF THOSE LAME/ RIDICULOUS PRODUCTS PROMISING 1600% INCREASE IN RESULTS BASED ON A STUDY THAT CAN BE CONDUCTED BY THE COMPANY AND THEIR PAID DOCTORS AND RESEARCHERS AND THEN THE STUDY’S RESULTS CAN BE DUMBED DOWN AND THEN ALTERED BY THEIR MARKETING DEPARTMENT TO SHOW HOW IT WORKS SO AMAZING, AND THEN PUT A DISCLAIMER IN FADED TEXT ON A COMMERCIAL SAYING THINGS LIKE “RESULTS NOT TYPICAL”, ” AVERAGE 1 OR 2 POUNDS A WEEK” AND ETC.
ARE ALL THESE RED FLAGS ABOVE GOING TO MAKE ME NOT USE CERTAIN SUPPLEMENTS…NO, BUT! UNLIKE MOST OUT THERE I CAN AND WILL SIFT THROUGH THE BS CLAIMS THAT YOU SEE TAKING UP PAGES IN MAGAZINES AND TIME IN INFOMERCIALS AND COMMERCIALS WITH SUPPORTING DOCTORS GETTING PAID BANK TO ENDORSE A PRODUCT. YOU NEED TO REMEMBER THAT ANYONE “ESPECIALLY CELEBRITIES!” WHO IS PROMOTING THE PRODUCT IS GETTING PAID TO DO SO! WELL WHAT IF THEY SHOW BEFORE AND AFTER PICTURES? THAT IS A WHOLE DIFFERENT TOPIC IN ITSELF AND I WILL ADDRESS IF NEEDED.
GOOD LUCK OUT THERE AND BE SMART!
ALWAYS REMEMBER THERE ARE INFORMATION PORTALS OUT THERE BETTER THAN YOUR FAVORITE ONLINE FORUM OR GYM RAT MEAT HEAD.
SOURCES: AVAILABLE TO ANYONE WHO WANTS TO LOOK!
http://www.fda.gov/Food/DietarySupplements/default.htm
http://www.health.gov/dietsupp/execsum.htm
http://www5.aaos.org/courses/cam/dsheasum.htm
http://www2.aaos.org/aaos/archives/acadnews/2003news/c6-7.htm