FDA – Page 2

News Update from EWG on Triclosan Ban

The U.S. Food and Drug Administration (FDA) banned triclosan and other antibacterial ingredients in hand and body washes, effective Sept. 6, 2017. (Included in this ban are Body Washes, Facial Soaps, and Hand Soaps)

Triclosan is an antimicrobial chemical that pollutes people and the environment. It is found in most Americans, where it may be interfering with the hormone and reproductive systems and increasing sensitivity to allergens. Although Triclosan will soon be banned from soaps because of concern that it is neither safe nor effective, yet it may be found in hundreds of other products. EWG’s review of industry documents and government databases on approved uses identified places all around the house where triclosan may be hiding.

Triclosan and other antimicrobials, added to many soaps and other everyday products – and found in the bodies of more than three-fourths of Americans – likely harm people’s health and the environment, while providing no benefit to consumers, said more than 200 scientists and medical professionals in a consensus statement published on June 20. The statement in the peer-reviewed scientific journal Environmental Health Perspectives, coauthored by EWG, recommends an end to the indiscriminate and widespread use of triclosan, triclocarban and other antimicrobial chemicals in cosmetics and consumer products.

EWG and the scientists who signed the statement believe antimicrobials should only be used if adequate testing shows that they are safe and they have been proven effective for particular uses. Scientists are concerned that widespread use of antimicrobials in consumer products could contribute to growing antibiotic resistance and make the vital medical uses of antimicrobials ineffective. On September 6, as a result of many years of efforts by EWG and other public health and consumer interest organizations, a Food and Drug Administration ban will go into effect, prohibiting the use of triclosan, triclocarbon and 16 other antimicrobial chemicals in soap products. This action comes four decades after the FDA said it did not have data to show triclosan was safe or effective, and raised concern about human health and the amount absorbed through the skin. However, the agency will allow continued use of the chemicals in other personal care items. Triclosan in personal care products is just one part of the story. While the antimicrobials market changes all the time, triclosan is still approved for use in building materials, housewares, cleaning supplies, textiles and apparel, and outdoor and sports gear. It is also permitted in phones, toothbrushes and razors, and in children’s items, such as bibs, toys and playground equipment.

February 2017

The latest from ANH, one of our best Health Freedom advocate organizations:
ANH-USA: The Pulse of Natural Health Newsletter (ANH-USA.org)

2017: Let’s Win Some More

Looking ahead, here’s what we hope to/can accomplish by all working together.

Stop FDA’s Current Attempt to Eliminate New and Better Supplements-

Simply put, the FDA has mangled Congress’s original intent when it enacted in the Dietary Supplement Health and Education Act of 1994 (DSHEA), imposing what is in reality a pre-approval process on all supplements developed or modified since 1994. If the FDA’s NDI (New Dietary Ingredient, i.e., new supplement) “guidance” stands, thousands of supplements will be eliminated from the market. We must not allow this. (As our readers know, supplements are not drugs. Being natural foods, they cannot be patented. No company can spend billions for FDA approval as drugs. They are already regulated, are the safest thing we consume, and the FDA has the power to remove any one of them from the market. Who will be helped if supplements cost $100 a bottle or require a prescription? Only drug companies, of course.)

Break Up the FDA-

Winning the NDI battle isn’t enough. The FDA, as currently structured, is not fit to regulate either food or supplements. It dances to the tune of the drug companies, which directly pay its bills. The FDA controls over a quarter of the American economy. The first step is to break it up into a food and supplements agency and a drug agency. This is the only way to ensure that the sale of healthy food and supplement products are promoted by the regulators rather than censored and blocked at every turn. People in charge of regulating drugs should not call the shots for food and supplements. This is the tail wagging the dog. But it is exactly what we have today.

Make the FDA a Safety Watchdog Once Again –

Prior to the Kefauver-Harris Amendment to the Food, Drug and Cosmetic Act in 1962, the FDA was charged with ensuring safety. Afterward, it had to approve effectiveness as well. This was well intended, but completely unrealistic. Congressional auditors agree that the agency is not competent to decide on effectiveness. It never will be. It relies on outside experts, but these experts are too often bought and paid for by industry—or else they want to preserve their own lucrative medical practices by preventing new drugs, technologies, or procedures. Let the FDA concentrate on safety. Then let the medical profession work out effectiveness.

Just Say No to (Prescription) Drugs –

Building a healthier America also requires breaking the stranglehold that Big Pharma has on healthcare in this country. In earlier articles, we suggested that Americans have become addicted to legal drugs that often offer more harm than benefit. We will continue to report on the dangers of pharmaceutical drugs, including opioids, antidepressants, statins, acid blockers, and so many more.

Read the inserts of drugs today: most have alarming side effects; most have never been tested on the young or the old; and many are simply not effective. We will continue to arm consumers with the information that will allow them, in consultation with their doctor, to “just say no” to legal as well as illegal drugs. We will also work to prevent healthy substances such as hemp extract, which can provide real pain relief, from being turned into illegal drugs for no reason other than to protect Big Pharma profits.

Preserve Customized Natural Medicines-

Many of us know that individualized medicine—in which treatments and cures are tailored to an individual’s biology and genetics—is the wave of the future. High-tech, innovative testing, followed by customized, natural medicines made at a compounding pharmacy, are key components of this approach to health.

A multitude of FDA actions in the past three years threatens to wipe traditional compounding pharmacies off the map—it’s “death by a thousand cuts.” And it’s quite deliberate—just another effort to clear the field for Big Pharma’s standardized, one-size-fits-all products. Different FDA “guidance” documents—which are very difficult to challenge—are aimed at the elimination of the traditional compounding industry. Two key areas of concern are the immediate threats to compounded bioidentical hormones and dietary supplements, because millions of consumers who rely on these products could lose them:

Save bioidentical hormones. Several critical hormones (progesterone, progesterone with estradiol, testosterone, and estriol) have been nominated to the FDA’s “Demonstrably Difficult to Compound” list. When completed, it will be illegal to compound items on this list. This would be a tremendous blow to everyone who relies on natural hormones to stay healthy—particularly in cases where no adequate substitute exists.
Save compounded dietary supplements. The FDA has said that, for supplements to be eligible to be compounded, they must appear on a pre-approved list. Yet the agency’s Pharmacy Compounding Advisory Committee (another stacked deck against natural medicine) has voted to reject important supplements—curcumin, boswellia, and aloe vera, to name just a few—from this list. More and more supplements will be banned from use. Intravenous vitamins and minerals are also at risk of being banned, either directly or by steps that could drive the price out of reach, which is an indirect ban.

A more comprehensive list of the various threats to the compounding industry can be found here.

We must fight to preserve the compounding industry as we know it, which means fighting the agency on each and every one of these policies through petitions, legislative action, and legal action.

Protect Pro Vaccine Choice –

It’s long been our position that reasonable questions can be asked about the safety of the current vaccination schedule. Some vaccines have dangerous adjuvants that have not been tested for safety; others do not. We believe that parents have the right to make informed decisions about the healthcare of their children. We reject laws like California’s SB 277 that take away this freedom. Children cannot be parented by the state. We will continue to fight mandatory vaccination in other states in 2017, as well as continue our legal challenge to SB 277.

Fight Crony Medical Monopolies –

The Academy of Nutrition and Dietetics (AND), the American Medical Association (AMA), and the Federation of State Medical Boards (FSMB), among others, all try to exert influence on state and national policy, often to exclude practitioners whom they regard as competitors. We will continue to fight for a level playing field and oppose state-level monopolies on the practice of medicine and nutrition. We will oppose the FSMB’s efforts to control the practice of medicine in as many states as possible.

This is just a glimpse of the year ahead. We won many battles in 2016 and with your help will win even more in 2017.

October 2016

Important Read Regarding NSP Products

We share the following information with you because of a recent development within the FDA that could possibly affect one of our NSP products, GABA Plus. Our GABA Plus doesn’t contain niacin, as does Picamilon. However, NSP works within the safe borders of using a conservative approach on products that might get the FDA’s attention so as not to be challenged by them in any way that could disrupt our availability to the products we depend upon. Please read the article and form your own conclusions. To be safe, Dick & Joy have chosen to order additional GABA Plus.

FDA Set to Yank Brain Health Herb

By ANH-USA on September 13, 2016

A number of months ago Sen. Claire McCaskill (D-MO) called for the removal of Picamilon and Vinpocetine from store shelves, pending a review of their status as dietary supplements. Sen. McCaskill, who is clearly doing industry’s bidding, claimed these supplements were synthetic and not natural, but that wasn’t true. Picailon is a combination of GABA (a substance made from the amino acid glutamine) and niacin (vitamin B3). Vinpocetine is a derivative of the lesser periwinkle plant, making it akin to a botanical extract.

The FDA recently said that it has reached a “tentative” conclusion that Vinpocetine is an illegal dietary ingredient because 1) it does not meet the legal definition of a dietary ingredient and 2) it is being investigated as a new drug. This FDA move could have serious consequences.

In the 1990s the agency accepted five New Dietary Ingredient (NDI) notifications on vinpocetine. (NDI essentially means “new supplement.”) Part of the NDI notification process is determining whether an ingredient meets the definition of a supplement. Why is the FDA all of a sudden reversing its decision?

According to the new draft NDI guidance, if a supplement is converted into a drug, but no new drug comes to market, the substance simply disappears. Remember too that in the new NDI guidance, the FDA has stated that it does not consider synthetic botanicals to fit the definition of a dietary ingredient (i.e., supplement)—a position that agency is apparently starting to enforce. We think it’s nonsense: nothing in the landmark Dietary Supplement Health and Education Act of 1994 states that synthetic and natural botanicals should be treated differently. The FDA is interpreting the statute as it wishes in order to hand as many of these substances to Big Pharma as possible. What’s next? Will bioidentical hormones be turned into drugs by the FDA?

Vinpocetine has a number of uses, including neuroprotective effects; it improves brain health and cognitive function, and has virtually no side effects. Dr. Russell Blaylock, in the February issue of his Blaylock Wellness Report, notes that other positive effects of vinpocetine include reducing cellular calcium (too much calcium in cells is very toxic), improving blood flow, reducing excitotoxicity, protecting mitochondria, reducing inflammation, reducing fat peroxidation, and exhibiting anti-cancer potential.

We must push back against this latest grab by the FDA as it once again shamelessly fronts for the pharmaceutical industry