National Issue Update – April 19, 2013

Sunshine Health Freedom Foundation has for a number of years focused its national activities under the banner of the website.  In 2013, to streamline and provide a single ‘go to’ site, we are blending back into the SHFF website.

Our goal is to make sure everyone is informed of the national and international issues that may affect our health freedom.

Covered Topics Include:

  • National & International Regulations & Guidelines
  • Legislation & Politics
  • Enforcement Actions
  • News & Research
  • International Treaties and Organizations (Such as the Codex Alimentarius)

For Areas of Specific Interest to the Health Freedom Community Including:

  • Dietary Supplements
  • Foods Including Organics and Genetically Modified (GMO) Crops & Foods
  • Homeopathy
  • Complementary and Alternative Therapies

Hot Topics in April 2013

Dietary Supplement New Dietary Ingredient (NDI) Guidance Document:  In July 2011, the Food and Drug Administration (FDA) published a proposed NDI Guideline for Dietary Supplements.  This was long awaited by industry as it is one of the final sections of the 1994 dietary Supplement Health and Education Act (DSHEA) to be implemented.  The Guideline had a number of provisions what were out of line with the existing law and was a clear attempt to change the law through an administrative document.  Your calls, letters, and comments to the record contributed to the decision by the FDA Commission to go back to the drawing board on the guideline and to include the community in that process.  As of early 2013 they have taken no action.  We will keep you posted on the news and action items on this issue.

Energy Drinks (caffeine):  The economic success of a group of products typically referred to as ‘energy drinks’ or ‘energy shots’ are the latest targets in the dietary supplement/food industry.  Last year Senator Richard Durbin, a powerful democratic Senator from Illinois, was joined by Senator Richard Blumenthal of Connecticut in the introduction of legislation that would have undermined DSHEA.  His latest focus on the supplement industry is ‘energy’ products.  Products with names like “Monster”, “Red Bull”, and “Full Throttle” are marketed sometimes as foods and sometimes as dietary supplements.  These legislators have stated that industry is taking advantage of what they perceive as ‘loop holes’ in food and drug law that allow companies who market liquid products as either supplements or foods.  They have recently been joined by Congressman Edward Markey of Massachusetts in this activity.  The legislative staff from these offices recently investigated 14 companies and issued a report entitled,

“What’s All the Buzz About?”  (

It looks like there is a move to set an upper limit of caffeine in these products, as well as to include the following warning on the label:   “This product is not intended for individuals under 18 years of age, pregnant or nursing women or for those sensitive to caffeine. Consult with your doctor before use if you are taking medication and/or have a medical condition.”

While most of the products specifically named are manufactured by large corporations such as Dr. Pepper, Coca Cola and PepsiCo; there will be a trickle down to dietary supplement companies that produce ‘energy shot’ products, other products that include caffeine. We are monitoring this closely.  We know there is an underlying goal by the “anti-DSHEA” crowd to shift dietary supplement regulations into a model that mirrors drug regulation, requiring pre-market approval of products and other more onerous regulations.  Such a move would only serve to drive the cost of supplements up, force small companies out of the market place, and lead to limits on some ingredients.  SHFF believes that both the FDA and the Federal Trade Commission (FTC) have sufficient authority to regulate supplements and foods.

DMAA Warning Issued:  Dimethylamylamine also referred to as 1,3-dimethylamylamine, methylhexanamine, geranium extract, or simply DMAA is an ingredient the FDA is focused on.   In April 2012, the FDA issued warning letters to 10 manufacturers and distributors of dietary supplements containing DMAA.  The FDA had determined that DMAA is a New Dietary Ingredient and wants safety data submitted.  This month, the FDA issued a public warning, after determining they consider DMAA to an illegal ingredient.  USPlabs has submitted data to the FDA to keep the product in the market place, while other companies have agreed to remove it from products.  The FDA, who last year included in their announcement a push for adverse events reports, announced they have received 82 adverse event reports on DMAA products, mostly from consumers.  The agency confirms that there is no confirmation that the adverse events that were reported are confirmed to be the result of taking a DMAA containing product.  It appears that USPlabs will fight the FDA’s decision.  We will keep you updated as things develop.

Folic Acid:  Two National Institutes of Health (NIH) offices announce research activity to evaluate ‘the safe use of high intakes of folic acid’ and ask for public input.  The National Toxicology Program (NTP) of the National Institute of Environmental Health Sciences (NIEHS) and the Office of Dietary Supplements (ODS) is planning a workshop to identify research needs based on consideration of the state of the science related to the safe use of high intakes of folic acid.  This project aims to identify research needs and inform the development of a research agenda for evaluating the safe use of high intakes of folic acid.  The NIH has published a notice of this project in the Federal Register and requested input.  The Comment Period Closes on May 28, 2013.

The following website links are relevant to this activity:

Federal Register Notice:

NTP Folic Acid Approach document:

Online Submission website:

SHFF will be submitting comments to the record and posting them on this site.

Check back soon.