August 29, 2014

FDA Breaks Promise on Proposed New Supplement Rules

pin it button FDA Breaks Promise on Proposed New Supplement Rules

Vitamin Herbal Supplements FDA Breaks Promise on Proposed New Supplement Rules

by Alliance for Natural Health

FDA promised not to enforce the NDI guidance until it was final. Last Friday, they broke that promise.

The specific provision that FDA has decided to enforce is the one that says synthetic botanicals will no longer be considered New Dietary Ingredients and must never be sold as supplements, only as drugs. Last Friday, FDA issued a press release and sent warning letters to ten companies who sell supplements containing DMAA (dimethylamylamine), which is advertised to increase energy, concentration, and metabolism. The manufacturer says DMAA is derived from the Asian geranium—specifically, geranium oil.

In their warning letters, FDA said the supplements are technically classed as “adulterated” for two reasons: (1) DMAA has not gone through the NDI notification process, and (2) it is a synthetically produced botanical which, by definition, is not an NDI.

However, the claim that a synthetic botanical is not a dietary ingredient is nowhere to be found in the law governing supplements: the Dietary Supplement Health and Education Act of 1994 (DSHEA). This new distinction comes exclusively from the NDI draft guidance, which is one reason we called it a perversion of congressional intent.

For years drug companies have studied plants for medicinal uses. As we noted recently, if they find a useful plant, the next step is to try to create a synthetic analog of the natural plant substance—a new molecule that can be patented and then taken through the FDA as a new drug. With this provision in the NDI draft guidance, FDA is giving drug companies a monopoly on synthetics, knowing full well that, in general, natural products cannot be patented while synthetics can, and only patented substances can afford to be brought through the hugely expensive FDA approval process.

The worst part is that FDA is now treating the guidance as if it has been finalized—something they promised not to do. In February, FDA held a meeting with the Natural Products Association (NPA), and explicitly told the group that until FDA finishes reviewing comments and releases final guidance, it would enforce only DSHEA and not the draft guidance. Now they’ve gone back on their word.

In addition, we would point out that FDA has still not addressed the many formal comments that were submitted on the synthetic botanicals question. We, and many others, said that FDA’s claim that synthetic constituents of botanicals are not NDIs while synthetic constituents of any other substance are NDIs is a completely arbitrary distinction. Taking action when they haven’t reviewed any of the thousands of pages in public comments makes a complete sham of the formal comment period. Moreover, FDA shouldn’t be enforcing a guidance when it is still in the draft stages anyway—that’s the point of it being a draft.

Worse, by going outside the bounds of DSHEA, the NDI guidance is basically creating new law, which the FDA is not allowed to do. Instead of issuing proper regulations and going through the formal rulemaking process (as is required when creating a new law), the FDA sidestepped everything by issuing a guidance. Technically, a guidance is not legally binding—which makes lawsuits difficult—but as feared, the FDA is enforcing the guidance as if it were.

DMAA is not without some controversy. Last year, two soldiers died after having heart attacks during fitness exercises, and both happened to be taking supplements that contained DMAA, though as of this writing, DMAA has not been conclusively linked to the deaths. A spokesperson for the manufacturer said that “there have been over one billion doses of DMAA-containing products taken without a single corroborated serious” health problem among people who used the products as directed. Just to be safe, the US Army is investigating, and the Defense Department has removed all products containing DMAA from stores on military bases until the safety review is complete.

If DMAA is proven to be unsafe, it should be removed, plain and simple. If it is a New Dietary Ingredient, then by all means it should go through the NDI notification process as outlined by DSHEA. But let’s just stop this nonsense about it being illegal because it’s a synthetic botanical—that is not a requirement of DSHEA. That requirement comes only from FDA, and it is not supported by law.

Here’s the crux of the matter: If FDA fully enforces this guidance as drafted, we will likely lose up to 29,000 nutritional supplements  from the market, at an economic loss of between $5.6 billion and $10.5 billion; the nutritional supplement market could shrink by between 28% and 52.5%, producing an annual loss for the industry of between $7.84 billion to $14.7 billion; and between 55,720 and 104,475 jobs in the supplement industry could be lost.

Let’s be clear: this is not about DMAA. This is the FDA setting in motion its draft guidance, which threatens our access to more than half of the supplements we all need to stay and get healthy.

Read the Full Article and Comment Here: http://www.anh-usa.org/fda-breaks-promise-on-proposed-new-supplement-rules/

0 commentsback to post

Other articlesgo to homepage

Study: Legalizing Medical Marijuana Leads to Fewer Prescription Drug Overdose Deaths

Study: Legalizing Medical Marijuana Leads to Fewer Prescription Drug Overdose Deaths

Pin It

A study published in the journal JAMA Internal Medicine on Monday found that states that had legalized medical marijuana had seen a 25 percent drop in deaths related to prescription drug overdoses.

According to ABC News, the researchers conducting the study found that because “legalizing medical marijuana makes it more available to chronic pain patients, it provides a potentially less lethal alternative to pain control on a long-term basis.”

Over the course of the study, the states studied were the ones that allowed access to medical marijuana. The Washington Post reported that those states “had 1,729 fewer overdose deaths in 2010 than would be predicted by trends in states without such laws.”

Dr. Marcus Bachhuber, a physician and researcher at the University of Pennsylvania, and the lead author of the study, told ABC News that while he did expect to see changes among the states that legalized medical marijuana, he found it “surprising that the difference is so big.”

Unapproved but Effective Cancer Cures

Unapproved but Effective Cancer Cures

Pin It

The conventional cancer treatment system and the pharmaceutical companies that control it are dedicated to limiting the development of all other forms of cancer treatment. They have a chokehold on the development of alternative treatments, and they ruthlessly work together with the US FDA and various US government cancer research funding agencies to prevent new treatments from being approved for use by physicians. The reason is that most alternative cancer treatments are much less expensive than surgery, radiation, and chemo. They are also more effective and have many fewer (if any) unwanted side effects.

The great fear of the pharmaceutical industry, and the vast cancer treatment system that it controls, is that a non-patentable and inexpensive cure for cancer might put them out of business. Sadly, these organizations exist to turn a profit from cancer treatment, which is measured in the billions of dollars every year. They are in the business of treating cancer not curing it.

Alternative treatments for cancer have a history of curing cancer and it is this fact that big pharma wants to hide from the American public. Historically, many successful approaches have been developed for curing cancer. We give a review of many of the most popular ones here.

Report: FDA Deliberately Deceptive – Poisoning Millions of Americans

Report: FDA Deliberately Deceptive – Poisoning Millions of Americans

Pin It

US consumers are in dark about mercury in dental products—and they are kept there deliberately by the government. This is documented in a new report being released this week by Consumers for Dental Choice called “Measurably Misleading: Evidence the FDA and Dental Industry are Deliberately Deceiving American Families about Mercury Dental Fillings and Why That Now Has International Consequences.”

Mercury is a known neurotoxin, yet mercury fillings presents one of the largest consumer consumption of mercury worldwide, and dental amalgam represents the largest use of mercury in consumer products in the US. We’ve also been kept in in the dark about mercury in other consumer products because of the FDA. Thimerosal, a mercury compound often found in flu vaccines, is being ignored as a danger.

Detox Your Liver with Homemade Lemon Water

Detox Your Liver with Homemade Lemon Water

Pin It

One of the drinks I routinely make for myself and my family in the mornings is lemon water. Not to be confused with “lemonade,” a sweetened beverage, lemon water is a detoxifying health drink consisting of nothing but one whole lemon and warm water.

Much of the research on lemon water’s ability to detoxify the liver is centered around the antioxidant D-Limonene, which is more concentrated in the peel of the lemon. D-limonene has been shown to activate enzymes in the liver that lead to detoxification. It has also been shown to treat cancer.

The Healing Properties of Clove Essential Oil

The Healing Properties of Clove Essential Oil

Pin It

The ancient texts all seem to agree on the many therapeutic properties of clove – it is a stimulant and has stomachic, expectorant, sedative, carminative, antispasmodic and digestive qualities. It helps flatulence, stimulates digestion and restores appetite, so is good for convalescence. It is a general tonic for both physical and intellectual weakness; and for those suffering from frigidity.

Its principal therapeutic value, though, is antiseptic because of the high proportion of eugenol. This is used for intestinal parasites, and for prevention of virus infections. It is good for the immune system, and particularly effective in mouth and tooth infections.

Here is a review of some of scientific studies published around the world regarding the healing properties of clove essential oil.

read more


Get the news right in your inbox!