Food and Drug Administration

The Food and Drug Administration, through its Code of Federal Regulations (CFR) in Title 21 requires that food, drugs, cosmetics, biologics, radiation-emitting electronic products, and medical devices comply with the labeling regulatory requirements. The general device labelling requirements are specified in part 801 of CFR 21.Some of other specific requirements are specified in detail in specific parts of CFR 21. They are:

1. In Vitro Diagnostic Products – 21 CFR Part 809.
2. Investigational Device Exemptions — 21 CFR Parts 812.
3. Good Manufacturing Practices — 21 CFR Parts 820.
4. General Electronic Products — 21 CFR Parts 1010.

Companies that do not meet the requirements of labeling as required by FDA will face action from FDA under the Federal Food, Drug and Cosmetic Act (FFDCA) that governs regulated products compliance.

General Device Labeling Requirements – The minimum labeling requirements are as follows:

1. Name and place of business: The device shall contain the complete name and place of business of manufacturer, packer, or distributor and the information must be qualified by an appropriate statement.

2. Intended use: If the product is used by either the packer, seller or distributor for purposes other than those intended for by the manufacturer, adequate labeling must be provided.

3. Directions for use: Directions under which a layman can use the device safety must be provided on the label like the dosage, frequency, duration, method of application and any necessary preparations must be included.

Exemptions – The exemptions are as under:

1. Prescription Device.
2. Retail Exemption.
3. Commonly Known Directions.
4. in Vitro Diagnostics.
5. Used in Manufacturing.
6. Used in Teaching, Research, or Law Enforcement.

Expiration of Exemptions:

The exemptions for the expire if they are used for purposes other than the exempted purposes.

Specific device labeling requirements – The specific requirements for device labeling of the following are mentioned in separate sections of the title and need to be adhered to:

1. Denture repair kits.
2. Impact resistant lenses in sunglasses and eyeglasses.
3. Ozone emission levels.
4. Chlorofluorocarbon propellants.
5. Hearing aids.
6. Menstrual tampons.
7. Chlorofluorocarbons or other ozone depleting substances.
8. Latex Condoms.
9. Devices containing natural rubber.

Why Are Holistic Medicines Not Approved By The Food And Drug Administration

Basically, we need to understand what the difficulties are of getting non conventional therapies of any sort approved by the FDA in the United States. Below I have given some explanations why I believe this is the case.

The entire medical establishment alongside government agencies believe that only pharmaceutical drugs can cure a disease. Any form of alternative cure or therapy is as a result treated with disdain. Therefore, it is difficult for Holistic medical practitioners to overcome these prejudicial hurdles in order to prove their effectiveness as a healing method.

Drug companies, which fund many of the studies for new drugs, have little or no interest in pursuing alternative treatments and cures. Since they are generally are inexpensive and cannot be PATENTED. Drug companies are in the business of making money with a drug that can be patented. You can not patent anything that exists in nature. You cannot for instance patent carrot or wheatgrass juice. There is no money to be made from spending millions of dollars on research to show that vitamin C helps to fight cancer, since anyone can buy the substance at the local drugstore.

The main criticism that the medical establishment has of holistic medical treatments is a lack of traditional scientific testing and documentation. One reason for the absence of mainstream research on alternative treatments is that the funding institutions that provide the money for cancer research for instance do not support research into alternative cancer therapies.

This situation creates a double bind for Holistic medical therapies: they are criticized for not having adequate research to document their effectiveness, yet funding is not made available for such studies.

The conventional medicine experimental approach calls for checking one substance at a time, and this approach leads to a search for a “magic bullet” that would be the cure for a particular disease. However, the very nature of this traditional research methodology ignores the multidimensional nature of the disease. What is needed is new ways to evaluate the effectiveness of Holistic medicines.

Diseases such as cancer and high blood pressure are multidimensional by nature. It is nearly impossible to study the effects of diet, therapeutic agents, and other influences in the conventional research framework. Investigating several variables calls for dozens of experiments and would require impossible amounts of research funding.

Another reason why there is lack of research into Holistic medical therapies for example is that many of those therapies are offered as part of an integrated program. For example, the National Cancer Institute’s laetrile (Vitamin B-17) study produced negative results. However, proponents of laetrile point out that the NCI study ignored diet, nutritional supplements, water and other substances that are synergistically involved in producing laetrile’s beneficial effects.

It is almost impossible to design a double-blind study to find out whether combinations of those different elements: colon cleanse, kidney cleanse, liver/gallbladder cleanse, dietary supplements, exercise, meditation, exercise, massage, acupuncture, oxygen therapy, juicing, love, support, etc, really cures cancer because double-blind studies are designed only to determine whether one or few therapies work. The lack of concise science in the approach of holistic medicines and the multidimensional characteristics of the diseases and the therapies at work makes it difficult to be clear which therapies are effective.

In a world where logic reigns supreme it is difficult to explain a therapy or treatment that has no logical explanation. For example antibiotics are designed to kill bacteria both good and bad in the body. Garlic kills bad bacteria but allows good bacteria to flourish! How do you explain that. Many alternative therapies cannot be easily explained with logic, they however do have intuitive appeal.

The one size fits all approach of conventional medicine is designed to provide a solution to a particular symptom regardless of the underlying causes. Holistic medicines however, are often individually suited for every single patient. The many patients you have, that’s how many therapies you are going to get. What caused the symptoms of one person may be entirely different to what caused it for another. Just like the cancer diet. You have as many individual diets as you have individuals. They can not be evaluated as one single therapy.

Holistic therapies take a WHOLISTIC APPROACH. It takes the workings of the mind, body, and spirit together. We still do not have a science to evaluate this. In other words, most natural programs for curing cancer can not be proven effective by the same means as conventional therapies. Breaking programs in separate pieces and evaluating every single piece individually rarely yields positive results.

Normally, it takes the FDA about 10 years and cost up to $250 million for a new cancer drug takes to be approved. Many drugs are well researched and marketed in other countries, but remain unapproved by the FDA in the U.S. This sadly is also true for a number of the alternative natural therapies.

Bolaji Alli is the founder and CEO of Holistic Miracles, an international organisation committed to empowering the physical well being of humanity. He has spent the last twenty years researching into various areas of alternative healing methods such as herbalism, nutrition, acupuncture etc. He is also a distributor for Nature Sunshine products.

Texas Relates To Import Safety Issues As China Executes Its Top Food and Drug Administrator

China’s official Xinhua news agency announced yesterday the execution of Zheng Xiaoyu, the former head of its State Food and Drug Administration, in an attempt to show the country’s seriousness about cleaning up obvious problems with exporting contaminated food and drugs.

Xiaoyu was convicted of accepting bribes totaling the equivalent of one million USD to approve untested drugs. The Beijing No. 1 Intermediate People’s Court carried out the sentence after denying appeals from Xiaoyu, who argued the punishment was too harsh for the crime, and that he had confessed to his wrongdoings. Evidently, it wasn’t enough. Xiaoyu was the first ministerial-level official executed in China in seven years, and only the fourth within the past thirty.

The execution is expected to be met with mixed reviews by the American public, which has been outraged by China’s continuous problems with contaminated food and drugs. Numerous industries — from major retail chains, to the health insurance and health care industries — have been trying to contain serious health and safety risks from the products. Hundreds of human and animal lives have been affected in the U.S. alone.

But putting an individual to death for accepting bribes also is riling up human rights’ activists, many of whom argue that, no matter one’s stance on the effectiveness of the death penalty, it should not be considered for nonviolent crimes. China’s reputation for violating human rights, after all, is no better than its reputation for exporting dangerously contaminated goods.

The nationwide contamination earlier this year of some of the U.S.’s top pet food brands by wheat protein imported from China was only the latest in a series of scandals involving compromised products from the country, including tires, children’s toys, vitamins used for baby formula, and toothpaste. Even phony anti-malarial drugs have been exported and used, killing or further sickening desperately ill patients.

Texas understands this issue well. With so many products legally and illegally imported from the border, and with only 1% of all of the nation’s imports being inspected by the Food and Drug Administration, it’s likely that nearly any establishment in the state selling almost any goods — from Dallas, to Houston, to Austin, to the tiny border towns — is making available a product American regulatory industries would never allow to be produced in the U.S. Even fruit is subject to different regulations in Mexico, and is often sprayed with chemicals now banned in this country. The problems with Chinese imports, then, which circulate throughout every state, only adds to the problem, and Texans have been shown to be less than tolerant about products on the market that could put public health at risk.

China knows America’s outrage, and is making overt efforts to reassure the Western public of its commitment to safety, including the conviction and execution of Xiaoyu. Without its exports, the Chinese economy would collapse. Wal-Mart alone is China’s eighth largest trading partner, and over 90% of the vitamin C sold in the U.S. is produced there. In fact, Americans would be surprised to know that much of their aspirin, pain relievers, and antibiotics, including penicillin, are produced in China. Labels stating a vitamin or drug’s country of origin are not required in the U.S., however, and few products actually reveal it. Fewer Americans probably even think about it when picking up a prescription from the pharmacy.

This is certainly not to say that all products from China are dangerous, or even of poor quality. It’s the fact we simply don’t know that makes us cringe. We don’t know which exports are safe or, at times, even when we’re buying imported products, let alone imported drugs from a facility in China that may or may not be clean, and that may or may not be producing untested products. Xiaoyu’s willingness to accept bribes to approve untested drugs forces most of us to count our blessings that we weren’t one of the many malaria patients trusting phony medication, or one of the many beloved pets ingesting contaminated wheat protein. Perhaps this will be a turning point for China’s regulatory industry. Perhaps. But until then: buyer beware.

Making sure the products you buy are safe is one very important part of taking care of your health. How you take care of yourself will certainly affect you as you age, and eventually your wallet, as well.

Understanding US Food and Drug Administration Recalls

The Food and Drug Administration, the agency n charge of regulating the safety of drugs is the Food and Drug Administration, is empowered by the US government to review the application of a pharmaceutical company to manufacture and release to the market any new drug it develops. The FDA also can issue a recall for any drugs that it deems dangerous for consumers. It also issues valuable safety information so that the general public would know about which drug is unsafe to use.

Sometime, however, the important safety information which is being issued regularly by the Food and Drug Administration can be a little bit confusing. It is sometimes full of technical jargon that the consumer tends to get lost in the meaning of the words and paragraphs and some mistakes are made because of this.

To put it more clearly, the FDA can order a pharmaceutical company to recall what it deems as a dangerous drug that is being distributed in the market. The pharmaceutical company can also do it voluntarily if it finds out that the drugs in question are causing major side effects.

As soon as the recall is made by the FDA, the pharmaceutical companies must take full responsibility with regards to the pullout of these dangerous drugs and it also thoroughly checks that all the drugs in question are taken off the shelves. The pharmaceutical companies should also inform the FDA on the progress of the recalls until all the dangerous drugs are pulled out from the market.

During the drug recall, the FDA assumes the role of a monitoring agency and to ensure that the pharmaceutical company is following all the necessary procedures in pulling out all the drugs which have been found to cause serious side effects. After all the drugs have been pulled out, the FDA then would conduct an investigation on why the drug in question was defective and to supervise the destruction of all the recalled drugs or to make sure that the drugs are suitably reconditioned before they are reintroduced to the market.

There are three recall categories and these are Class I, Class II or Class III. In a Class I recall, the FDA finds that the drugs in question are causing serious side effects and a probable serious or fatal injury to the user exists and the drug has to be pulled out right away from the market. The Class II recall tells of a probability of injury to the user although not necessarily fatal but still one that can cause permanent damage to the user. The Class III injury meanwhile tells of a lesser, albeit, probable health risks which is why the drug is being recalled.

The United States Food and Drug Administration and NAFTA

The North American Free Trade Agreement (NAFTA) helps safeguard the ability of the United States Food and Drug Administration to ensure food safety and quality within North America. NAFTA is an agreement between Canada, the US and Mexico that took effect on January 1, 1994, designed to increase the scope for the free flow trade and investment among these three countries. The US Food and Drug Administration (US FDA), which participated in the negotiation of NAFTA, has reviewed the US Food and Drug Administration standards for safety, purity and appropriate labeling of foods and has determined that these standards are consistent with the terms of the agreement. This is why no changes in US Food and Drug Administration standards are needed or proposed to implement NAFTA.

NAFTA does not change existing or future US Food and Drug Administration standards regarding pesticide use or pesticide and other chemical residue or contaminant standards for fresh or processed foods. NAFTA provisions safeguard the ability of the US Food Drug Administration to ensure food safety. In short, existing US Food and Drug Administration standards will continue to be applied to imported foods as well as domestically produced foods. This means that the U.S. will continue to prohibit any food shipments determined not to meet pesticide residue or other food safety requirements.

NAFTA has no effect on U.S. Food and Drug Administration laws and regulations in the area of safety, effectiveness, and appropriate labeling of human and animal drugs and medical devices. Any products coming into the U.S. must continue to meet all US FDA standards and requirements.

Additionally, NAFTA does not change or affect US Food Drug Administration laws and regulations with respect to US Food and Drug safety and appropriate labeling of dietary supplements imported in to the U.S.

U.S. FDA and TWG

Within the auspices of the NAFTA, the three countries have developed a technical working group on pesticides called TWG. It serves as a focal point for all issues related to pesticides for these countries. TWG’s aim is to ensure that the countries can be assured of the legality and safety of foods produced in any of the NAFTA countries. US food and drug administration is providing trilateral cooperation between Mexico and Canada to enforce the TWG standards.

Article 723(6) makes explicit that any party challenging a U.S. Food and Drug Administration safety measure would have the burden of showing that the US Food and Drug measure is inconsistent with NAFTA. Whether any particular level of protection is “appropriate” is a social and political judgment that the agreement reserves for the government applying the measure (see Articles 712(2) and 724). As provided in Article 712, a sanitary measure is to be based on a risk assessment “as appropriate to the circumstances,” and is not to be maintained where there is no longer a scientific basis for it. US Food and Drug Administration standards are already based on risk assessments and have a scientific basis. These NAFTA requirements help assure that measures applied by the other parties will not unfairly exclude U.S. food exports.