Top Articles

Legislation is getting legs to further curtail your use of nutritional supplements. Not too long ago, prior to passage of the Dietary Supplement Health and Education Act (DSHEA) – which was accomplished by millions of letters to legi

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

slators by people like you – the FDA acted like a Gestapo against supplements, manufacturers and professional advocates. They would raid at gunpoint the medical offices of doctors advocating the merits of nutritional supplements, shut

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

down manufacturers, harass stores, confiscate products and prevent education of the public on nutritional labels. You know, because so many people were dying of supplements like Coenzyme Q-10 and herbs like the natural sweetener stevi

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

.

Not really. Actually, not at all. While they were busy making sure natural and safe substances were tightly controlled, millions of people were becoming ill and dying from their "approved" pharmaceuticals. It's like a policeman a

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

resting jaywalkers while letting rape occur in the alley.

I'm all for regulation that makes sense. The tight control over nutritional substances, however, is nonsense. Yes, there can be found evidence somewhere that some natural subs

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ances have caused harm. But so can water and oxygen cause harm if not used properly. Everything has a risk, but many things have great benefit, too. That is why full and honest disclosure is important and should not be impeded. Thi

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

s is actually a free speech issue that we should insist upon.

The FDA is basically an arm of the conventional medical establishment. Supplements and self-care are a threat to that establishment, and the resultant paranoia is what und

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

rlies onerous and picayune regulatory intrusion.

On to pet food regulation. Here it gets even more ridiculous. The freedoms extended by DSHEA to humans are not given to animals. Why? Because legislators forgot to write it in. So pet

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

food regulators approve "dehydrated garbage" (actual listing in the pet food regulators' handbook) and "dried poultry waste," but ban beneficial substances like Coenzyme Q-10, most amino acids, pollen, chondroitin, glucosamine, querci

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

in, ginkgo, certain omega-3 fatty acids and many others. Regulators busy themselves editing pet food labels to make sure the lethal "100% complete and balanced" claim is stated carefully and placed in the right label spot, and issue

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

stop sale" orders on products with labels not perfectly complicit. (To review these issues in detail, see Chapter 21 in The Truth About Pet Foods.) Each state (count 'em – 50!) has its own regulatory body, which can have its own rul

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

es. Plus there are regulations from The American Association of Feed Control Officials (AAFCO) as well as the FDA and USDA. The cost to manufacturers for scrapping and revising labels adds huge costs to the end consumer ... and not on

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

y brings no benefit but creates immeasurable harm by distracting from the central issue of pet health, namely, pets should be fed in variety and enjoy fresh foods offered, not force fed so-called “100% complete” processed foods at eve

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

y meal.

How do regulators justify not at least extending the freedoms of DSHEA to animals? Well, they say what is generally recognized as safe (GRAS) in humans may not be in animals. They can then cite the potential toxicity of choc

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

late or aspirin in cats. These are the same people who justify millions of animals tortured in laboratories to prove the safety of drugs in humans. In other words, GRAS substances should not be used in animals because human physiology

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

is different than animals, but pharmaceutical substances and biocides can be used in humans if they are deemed safe in animals. You figure the logic in that.

I'm sure there are many well meaning, hard working, honest folks in regulat

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ory agencies. They are just doing what law mandates. On the other hand, there are some budding little Hitlers amongst the groups as well.

But this is America and in America the government is supposed to be servant to the people, not

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

vice versa. Your voice is important and does have incredible power. Legislators want votes and that is the currency you can use to swing the system to your favor.

Tell regulators and legislators you want at least the rights afforded

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

under DSHEA maintained. (Please go to http://www.wysong.net/ehealth/appropriationscommittee.htm for contact information.) E-mail your senators today and ask them to vote to preserve your rights to free access to dietary supplements

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

nd that you would like your pets to have these rights as well. Fax also is effective, but mail will be too slow and may not even be opened for fear of terrorist bugs. Forward this to your friends and encourage them to take action also

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.toparticles.org.ua/article/131334/toparticles-Regulatory-Hooey-Protects-Us-From-Our-Own-Health.html">Regulatory Hooey Protects Us From Our Own Health</a>

BB link (for phorums):
[url=http://www.toparticles.org.ua/article/131334/toparticles-Regulatory-Hooey-Protects-Us-From-Our-Own-Health.html]Regulatory Hooey Protects Us From Our Own Health[/url]

Euphoria from cap-and-gown celebrations will quickly turn to real world culture shock for many college graduates this year. Certainly, landing a job is concern number one, but how will these young professionals fare once they begin their career? Are they actually prepared for what lies ahead? Andy Masters, author of the book Life After College- What to Expect and How to Succeed in Your Career, offers several pieces of advice for college graduates to get their career off to a great start-

There are a lot of me too newsletters. Because people have heard repeatedly that the money is in the list , they do not take time to understand that although the money is in the list, it may remain out of their reach unless they follow the right steps.

You would think that as tanks roll into a capital in support a military coup that a country’s stock market would tank as well. In Thailand it seems to be taken as business as usual and this is not exactly a compliment. The Thai stock market took no hit at all and is up 9.6% so far this year. The past year follows a scripted political pattern all too familiar to Asian hands.

Tags

Links

Top Articles - Regulatory Hooey Protects Us From Our Own Health

Related Articles: