The Acronyms of Regulation

 

 Plague describes a conspiracy to undermine American’s health through unhealthy products and excessive use of prescription drugs.

The acronyms of illness have developed sophisticated techniques like repetitive, spot and interactive advertising to surreptitiously invade children’s psyches.  Their ability to stimulate nerve receptors in the hypothalamus with molecules, images, sight, smells and sounds causes addiction. They know it does. It just can’t be proved.

They are a conglomerate of scientists, marketers and salespeople who help build brand identification through the use of addictive compounds, repetitive messaging and product placement.

 

The paid-for placement that is shown in movies, TV shows and news programs are one of the instruments that marketers use to increases sales of consumer goods.  

In 1997, the FDA drew up guidelines to allow these marketers the right to reach out to patients and sell drugs. In 2005, the Pharmaceutical Research and Manufacturers of America (PhRMA), , stepped in and issued its guiding principles on direct-to-consumer adverts of prescription drugs. Voluntary principles that acknowledge treatment and lifestyle options during the commercial went into effect in in 2006.

 

Direct-to Consumer (DTC) prescription drug advertising has been in use for a little over ten years but it already has become a major source of revenue for the venue that carry these adverts. It has also clearly become an effective method to influence doctors on their choice of prescription.

DTC advertising according to PhRMA improves patient care. They argue that by educating patients on new treatments and drugs, they can raises their awareness of underdiagnosed and undertreated conditions.

 

Drugs are classified into Schedules and regulated based on potential harm. It seems odd that patients are allowed to be targeted on which drug to take. If the purpose in creating Schedules in the first place was due to a patient’s inability to understand the mechanisms and efficacy of drugs, then why are they marketed to when they don’t have that knowledge.

 

The Federal Trade Commission (FTC ) is responsible for regulating food advertising and eliminating any deceptive practices. It is an independent federal agency established in 1914 for the purpose of protecting consumers from anti-competitive practices, deceptive marketing and unethical advertising.

Since 1994 the FTC has its own restrictions based on the the FDA's food labeling regulations. In applying those standards to advertisements for food, they have effectively banned all advertisements of food and dietary supplements that make any health-related claim.

Junk food marketing to children has no such restriction.  They don’t claim their products improve health, nor do they warn consumers of their dangers.  This omission leads consumers to conclude that their food is nutritious and good for health.  In fact,  the more a child is exposed to food advertisements, the more snacks and calories they consume.

 

One regulation that would make a difference in protecting children from effective advertising, is to require companies to inform consumers that consuming their products causes illness much like cigarettes.

Along with the total amount due, a receipt would be required  detailing the amount of calories they are paying for and if it is too  many, just like if it costs too much, they can return the item. Food consumption would certainly drop if this were common practice. Absent this, the war on kids will continue. They are defenseless.

The DEA and the USP

The Drug Enforcement Agency (DEA) is entrusted with enforcing the Controlled Substance Act. This law classified drugs into five categories, known as Schedules.

Drugs are classified based on their potential for abuse and whether they have any medicinal value.  The lower the Schedule, the more restricted the drug. The lowest being 1, the catch-all class that causes a drug to be banned because it has no acceptable use.

 

The DEA’s goal is to defeat medical marijuana initiatives. They are hounding proponents of medical marijuana much like Inspector Javert hunted Jean Valjean.  They are trying to prevent states from exercising their own laws. The greatest fear of the DEA is losing the war against marijuana when they should be looking for the real criminal who embed addictive compounds in foods and sell prescription drugs as if they were street pushers. Americans are being habitually poisoned and they go after weed.

 

The DEA’s obsessive enforcement of marijuana laws is due to erroneous conclusions and myopic recommendations of the USP.

Do they really believe there is no medicinal value in a plant whose library of phytochemicals have been demonstrated to promote healing.  Who are they kidding?  Is the best they can come with for their war on drugs

 

The United States Pharmacopoeia (USP) is the standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products. Among the standards it sets, is the  uniformity of dosage regulation that all prescriptions, over-the-counter medicines and dietary supplements must follow if they are manufactured and sold in the United States.

 

The USP was established in 1920 to set standards for drugs and monitor potential danger to the users of medications. The USP is a nonprofit, non-governmental organization that promotes the public health by setting standards for identification, strength, and purity of drugs products. Standards enforceable by the FDA.

 

The USP defines the therapeutic classes of drugs. This power allows them to dictate which drugs can be prescribed and paid for, and which ones can’t.

The USP is published each year and based on their evaluation the FDA takes action as does the DEA.  It is the recommendations of the USP that determine the profits of drug companies and which drugs laws to enforce.

USP Verification Process

The USP began monitoring the dietary supplement industry in 2002 and have made a huge stride in improving the quality of botanical by establishing its verification program.

 

The USP is attempting to improve the quality of dietary supplements by validating the manufacturing, purity and potency of dietary supplements by granting approval as if they were pharmaceutical compounds. Unfortunately, compliance is voluntary. The USP Verified Dietary Supplement Mark is awarded to supplements that pass the USP's verification process. It is based on four criteria. That all the listed ingredients are in their declared amount, that it does not contain harmful levels of contaminants, that it will break down and release ingredients in the body and that it has been made under the Good Manufacturing Practices as established by the FDA for 2008.

 

The Dietary Supplement Verification Program (DSVP), which includes adherence to GMPs and evaluates and verifies supplements according to stringent standards for purity, testing for potential contaminants, and accuracy of ingredient labeling. Products that pass DSVP’s rigorous requirements are awarded a mark that helps assure consumers, health care professionals, and supplement retailers that a product:

 

1. Contains the declared ingredients on the product’s label.

2. Contains the strenth and amount of the ingredients declared on the product’s label.

3. Meets the limits permitted for potential contaminants.

4. Has been manufactured according to USP standards and the FDA’s Good Manufacturing Practices (GMPs).

Unlike pharmaceutical drugs with single active components, dietary supplements often contain several dietary ingredients.This library of botanical compounds needs to be maintained to ensure the quality the supplement reflects that of the whole plant.

 

USP's Verification Program is designed to ensure that a company's manufacturing process meets the documentation review and quality contols required. These documents demonstrate that a manufacturer is producing products according to the specifications set out by the the USP and that the manufacturer meets the specifications and ingredient that the label claims.

 

 

 

When a dietary supplement manufacturer has met these requirements, the product under review is awarded the USP verification mark.

To ensure that the product continues to meet the requirements of the program, the program staff conducts market surveillance product testing, product documentation review, and manufacturing site audits, on a continual basis.

 

 

“USP's Verification Program is designed to be the most rigorous program currently available. It was created to help dietary supplement manufacturers meet USP's manufacturing practices for dietary supplements, and proposed FDA good manufacturing practices (GMPs).“