Health Freedom

October 2017

In a Federal Register notice published Sept. 6, FDA formally announced its plans to hold a meeting on Oct. 3 to discuss its future development of an authoritative list of old dietary ingredients exempt from notification requirements in the law. In a 2016 draft guidance published on new dietary ingredient notifications (NDINs), FDA revealed it was willing to develop an authoritative list of dietary ingredients that were marketed before Oct. 15, 1994, and consequently exempt from the NDIN requirements in the Dietary Supplement Health and Education Act of 1994 (DSHEA).

The planned meeting, an FDA official said “is critical to the efforts to develop an authoritative list.” Such a list could benefit FDA and the dietary supplement industry it regulates. “By providing clarity as to which ingredients do not require notifications, it would alleviate the burden on industry of preparing and submitting unnecessary notifications,” FDA stated in the forthcoming Federal Register notice. “Similarly, by eliminating unnecessary notifications, an authoritative list would enable us to more efficiently use our limited resources to review notifications for truly ‘new’ ingredients. In addition, an authoritative list would allow us to better focus our enforcement efforts in alignment with our strategic priorities of consumer safety, product integrity and accurate information.”

In separate panel discussions, the meeting will tackle two distinct issues that have elicited various opinions: the standard of evidence required to show an ingredient belongs on the pre-DSHEA list; and the process by which ingredients should be added to the list, such as the process for nominating and reviewing pre-DSHEA ingredients and how to treat confidential information.
FDA is allowing individuals to comment on the public meeting by submitting electronic or written comments by Dec. 4, 2017, and the agency provided instructions in the Federal Register notice for submitting confidential information. Submit electronic comments in the following way:

Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov

AICR Changes the Modern Understanding and Holistic Thinking About Cancer

Finally, someone who thinks the way we think and listens to us. Please check it out.

AICR has changed the modern understanding and holistic thinking about cancer.

http://www.aicr.org/learn-more-about-cancer/infographics/recommendation-on-supplements.html

The American Institute for Cancer Research recently made these statements:

AICR research shows that approximately 1 in 3 cancers could be prevented if we all ate better, moved more and weighed less. That’s nearly 345,000 cancers that don’t have to happen every year in the U.S. alone. Add in not smoking, and we could prevent hundreds of thousands more.

You can protect yourself today!

Eat more fiber-rich vegetables, whole grains, fruits and beans
Eat less beef, pork and lamb
Avoid processed meats like cold cuts, bacon and sausage
Drink less alcohol
Move more, in any way, every day
Stay a healthy weight
If you smoke, stop. If you don’t, never start.

In 1982, American Institute for Cancer Research (AICR) was founded to advance the simple but then-radical idea that cancer could be prevented. AICR focused on the link between diet and cancer, and immediately began supporting cutting-edge research in this area and educating the public about the results.

Today, they continue to fund research in the field of nutrition, physical activity and cancer prevention, treatment and survival. They interpret the results of that research, along with findings from the global scientific community, to craft reliable, evidence-based recommendations for lower cancer risk.

Action Alert from ANH USA!

Write to your representatives in Congress and urge them to support HR 2871. Please send your message immediately.

Congressmen Morgan Griffith (R-VA) and Henry Cuellar (R-TX) recently introduced HR 2871, the Preserving Patient Access to Compounded Medications Act of 2017. This is an important first step toward saving many natural, customized medicines from the chopping block. Without a doubt, this will receive significant opposition from Big Pharma and from the FDA itself making your support crucial for getting this legislation passed. This is our moment to act. We’ve been telling you for years how the FDA has been waging an all-out war on customized, natural medicines made at specialized pharmacies. FDA actions threaten to wipe these life-saving medications off the map. Congress has repeatedly scolded the FDA through language in congressional spending bills for distorting lawmakers’ intent and needlessly limiting patient access to important medications. The agency’s fidelity to Big Pharma is the only explanation we can develop for this lawless behavior. This new bill does two important things. It amends section 503A of the Food, Drug, and Cosmetic Act to unequivocally allow “office use” of compounded drugs, which allows a doctor to keep a supply of certain medications in his or her office in order to provide immediate treatment to patients who need it.

The bill also mandates the FDA to accept USP monographs. Last year the FDA, with no explanation or justification, stated that it would not accept supplement USP monographs. This meant that in order to be used in customized, natural medicines, supplements had to be nominated for the FDA’s pre-approved list. Many supplements were nominated, but, no surprise, the FDA rejected them. Even a supplement, however, like curcumin, with very important medical uses. Behind the scenes, of course, Pharma is trying to turn curcumin or a synthetic analogue in a drug. This bill doesn’t fix every misguided action of the FDA since the agency began implementing the Drug Quality and Security Act of 2013. However, this bill is a major first step forward in saving important natural medications from the FDA’s chopping block, and it needs our support.