FDA Struggles to Develop “Sugar Added” Labels for Honey and Maple Syrup

Last February, the Food and Drug Administration released guidance indicating it intends to require honey and maple syrup (as well as some cranberry) products to include “sugar added” labels with their nutritional content information. Concerned that “consumers would not be able to understand the relative significance of these sources of added sugars,” the FDA hopes new sugar added labels will help consumers make healthier choices. As FDA Commissioner Scott Gottlieb remarked, “We’ve made it our goal to increase consumer awareness of the quantity of added sugars in food products consistent with recent dietary guideline recommendations.”

These new labels follow guidelines established by the 2015-2020 Dietary Guidelines for Americans which “Defines ‘added sugars,’ in part, to include sugars that are either added during the processing of foods, or are packaged as such. The term includes…sugars from syrups and honey [italics mine].”

If you find the idea of requiring syrups and honey to have “sugar added” labels for containing sugars from syrups and honey confusing or misleading, you are in good company.

Let Competition, Not the FDA, Resolve the EpiPen Shortage

The Food and Drug Administration recently approved the first generic version of EpiPen. EpiPens provide swift, and potentially lifesaving, treatment for those with anaphylaxis (allergic reactions requiring emergency medicine). Anaphylaxis is surprisingly common, affecting between 1.6 percent and 5.1 percent of the U.S. population.

The release of a generic alternative to EpiPen provides medical and financial relief for millions of Americans. It also comes at a critical time. As FDA Commissioner Scott Gottlieb remarked, “This approval means patients living with severe allergies which require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages.”

Government vs. Private Efforts to Promote Breastfeeding: My Response to a Critic

I recently published an op-ed at The Hill entitled “Breastfeeding Controversy Shows Need for Private Efforts—Not Government Campaigns.”The piece came after U.S. ambassadors faced considerable criticism for attempting to block a World Health Assembly resolution calling for governments to devote more resources to promoting breastfeeding and to place more stringent advertising regulations on breastfeeding substitutes in developing nations.

Instead of criticizing politicians, I tried to address what I consider a more pressing question: Do we really want governments more involved in promoting global health efforts? My answer was no. To justify my stance, I provided peer-reviewed research indicating that government efforts to promote public health and improve living standards in developing countries have repeatedly failed. As an alternative, I provided evidence that private efforts to promote childhood nutrition (specifically breastfeeding) were more up to the task.

FDA Considers Regulating E-cigarette Juices

Last March, the U. S. Food and Drug Administration announced its intention to lower nicotine levels in cigarettes to prevent future generations from smoking and to help current smokers quit. In a piece I wrote in May for Inside Sources, I argued these regulations were unlikely to help and could possibly make things worse by motivating smokers to consume more cigarettes or switch to other, less healthy smoking products.

The FDA acknowledged this shortcoming in a regulatory notice which reads, “If a [regulatory] standard were to apply to cigarettes only, it could be substantially less effective.” But instead of heeding potential unintended consequences as a reason to refrain from regulation, the agency seems to be doubling down.

FDA Approves Medical App for Contraception

The Swedish phone app Natural Cycles recently made headlines for becoming the first app approved by the Food and Drug Administration for contraception. Natural Cycles uses morning temperature readings and its own algorithm to predict the user’s most fertile days (about ten days a month) during her ovulation cycle. The app has widespread popularity with nearly 700,000 users worldwide.

Although Natural Cycles is celebrated as being “first of its kind,” when we examine recent trends in medical technology, we find this story has been a long time coming.

Open Up Off-Label Drug Communication and Let the Market Work!

The Food and Drug Administration determines which drugs can be prescribed in the United States. However, the FDA does not tell physicians how to prescribe drugs. When physicians prescribe drugs for uses other than their FDA-approved use, they engage in off-label drug prescription.

Off-label drug prescription is extremely common. By some estimates, 25 percent of all prescriptions are for off-label uses. These rates can be exceptionally higher for conditions with few available treatments. Cancer, HIV/Aids, many mental illnesses, and large sections of pediatrics heavily depend on off-label drug prescriptions.

Three Reasons To Be Optimistic about Pharmaceutical Policy

To say the U.S. pharmaceutical market is highly regulated is an understatement. According to the RegData database developed by the Mercatus Center at George Mason University, the pharmaceutical and medical manufacturing industry as of 2014 had approximately 10,000 more restrictions than the median U.S. industry. Many of these restrictions are enacted by the Food and Drug Administration, which determines whether pharmaceuticals can enter the U.S. market legally. The approval process each drug undergoes is time-consuming (typically requiring 12 years) and expensive (costs can exceed $1 billion).

Political rhetoric suggests little is likely to change. Attorney General Jeff Sessions reportedly involves himself in the DEA’s distribution licenses to grow marijuana for medical research, an unprecedented role for his position. To combat the opioid crisis, President Trump called for fewer prescriptions and possibly the death penalty for illegal distribution. Both proposals create more barriers to patients seeking pain relief or suffering from addiction. The FDA recently began issuing warning letters to companies distributing goods containing kratom. Although the agency considers kratom to have “opioid properties,” kratom is legal in most states.

If Telemedicine Is Underachieving, Government Is to Blame

Telemedicine, the use of telecommunication technology to help administer medical care, is often credited with “radically changing” the healthcare market. Some have credited telemedicine with revolutionizing healthcare delivery, private practice, and outpatient care among other components of healthcare.

However, a recent CNBC article is receiving considerable attention for arguing that “telemedicine has been such a bust so far.” In the article, technology and health reporter Christina Farr contends telemedicine fails to live up to its reputation as “the next big thing in healthcare” and still finds itself on the outskirts of mainstream healthcare and medical practice.

Misdiagnosing Right-to-try Laws

In a recent press release, Congressman Jason Lewis (R-MN) urged the House of Representatives to pass recent ‘right-to-try’ legislation “as soon as possible.” Lewis also said, “I want each and every treatment option that could save a life to be available to those who are sick” and that “Families are depending on us.”

President Trump and Vice President Pence echoed similar sentiments. In his State of the Union Address, President Trump stated, “It is time for the Congress to give these wonderful Americans the ‘right to try.’ ” About three weeks ago, Vice President Pence tweeted, “Let’s get this [right-to-try] DONE.”

Putting Right-to-Try Drug Prices in Perspective

Brainstorm Cell Therapeutics Inc. recently made headlines for attempting to offer an experimental treatment for amyotrophic lateral sclerosis (commonly shortened to ALS or called Lou Gehrig’s disease). This path-breaking treatment, named NurOwn, is a personalized cell therapy which works to promote motor neuron growth to reestablish nerve-muscle interaction.

The treatment was going to be the first attempt to offer patients access to experimental treatment under the new national right-to-try legislation. However, due to a lack of funding, Brainstorm decided not to pursue this option and instead focus on FDA approval. NurOwn is currently in phase 3 of the FDA’s approval process and will likely be approved in 2019 or 2020.