News, Policy & Economics

Gottlieb Resignation Leaves Key Supplement Rules in Limbo

By Erik Goldman, Editor

FDA Commissioner Scott Gottlieb’s surprise resignation earlier this month sent shockwaves through the natural products industries. His departure at the end of March will leave two key aspects of dietary supplement regulation in limbo: the legality of CBD supplements, and the possibility of a major revision of the Dietary Supplement Health and Education Act (DSHEA).

Cannabis & Hemp: A Regulatory Update

By Erik Goldman, Editor

The year 2018 was a landmark in the history of hemp and cannabis in the US. It was the year the FDA approved the first natural cannabis-derived prescription drug, and Congress passed a Farm Bill that included provisions legalizing cultivation of, and interstate commerce in, low-THC hemp. But the laws and regulation around hemp and cannabis remain a confusing patchwork, and some states are taking regulatory actions that run counter to the new federal provisions.

Cannabis, Hemp, Marijuana: What's in a Name?

By Erik Goldman, Editor

Amid the current rage for all things cannabis, there is a lot of confusion about the terminology used to describe this plant and compounds extracted from it.

Part of that confusion arises from the Farm Bill of 2018, which changes some federal definitions. These changes have major implications for legal and regulatory policy.  Here’s a guide to common cannabis-related terms and their current definitions.

Migrants at the Border: US Citizens Head South for Cheap Medical Care

By Erik Goldman

There are a lot of anxious, needy people eager to cross the line that separates the US from Mexico. Go to the border towns of Southern California and Arizona, and you’ll see them--- US citizens heading south to Mexican clinics and farmacias, seeking lower cost surgeries and cheap meds.

Medical and pharmacy “tourism” to Mexico is a large and growing phenomenon, one that has received little attention amid the bitter political rancor over immigration policy and border control.

FDA Revamps It's Field Guide to Food Additives

By Kristen Schepker, Assistant Editor

Food ingredient list There are well over 10,000 chemical additives--flavorings, colorings, preservatives--that the federal government permits for use in food products sold in the US. While a few occasionally grab headlines--think monosodium glutamate, sodium nitrite, high-fructose corn syrup, aspartame--the vast majority garner very little public attention.

Equally under the radar is an underutilized but quite informative database maintained by the Food and Drug Administration, and formerly known as "Everything Added to Foods in the United States" (EAFUS). Late last year, the FDA relaunched the site under  a new title: the Substances Added to Food inventory.

In addition to its name change, the revamped index boasts several updated features, including novel search functions and links to relevant regulatory information.

Think of it as a field guide to those commonly-used chemicals that add lots of polysyllabic Latin and Greek to the ordinary average ingredient label.


The FDA's Office of Food Additive Safety (OFAS), which maintains the Substances Added to Food inventory, announced the launch of its upgraded ingredients catalog in June 2018. Earlier versions of the EAFUS database have existed online since 1999, providing information on various types of food ingredients, additives, and packaging substances. 

The revamped inventory includes approximately 4,000 different ingredients--less than half of the total in current use by the food industry (Neltner TG, et al. Reproductive Toxicology. 2013; 42: 85-94). But it does cover the most common food and color additives, flavoring substances, Generally Recognized as Safe ("GRAS") substances, and other chemicals approved for specific uses in foods.

Items appear in the inventory according to ingredient names as recognized by the FDA's Center for Food Safety and Applied Nutrition. When available, the site offers direct links to any applicable regulations for a particular food substance, as well as additional information like other commercial or brand names and common uses for specific ingredients.

Individual food ingredients that are federally regulated appear alongside official regulation or identification numbers and include links to details about the specific approved uses for those food substances.

In addition to chemicals the FDA considers safe to eat, the database also includes information on substances that were formerly Food additives health risksImmunomodulatory properties of common food additives (From Dar H, et al. Intl J Immunother Ca Res. 2017).permitted but are now prohibited, as well as delisted color additives, and food ingredients "no longer FEMA GRAS."

FEMA (no, not that FEMA, but the Flavor and Extract Manufacturers Association), was established in 1959 to independently assess the safety and GRAS status of food ingredients in accordance with the 1958 Food Additives Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act). This regulation governs flavorings and other food additives.

Database users can also access a new search feature to simultaneously pull up ingredient information from multiple other related food ingredient and packaging inventories, including GRAS and environmental safety notices.

That feature comes in very handy, because there are some serious gaps in the Substances Added to Food database.

For instance, a basic search for "glyphosate"––the most widely used agricultural weed and pest killer implicated in numerous human and environmental health challenges––returns zero results from Substances Added to Food, despite evidence that residues of the pesticide wind up in many food and beverage products. But a search across additional datasets reveals nearly 40 hits for glyphosate, mostly pertaining to the development of genetically modified, herbicide tolerant food crops intended for human use. 

Inclusion Doesn't Guarantee Safety

The inclusion of a specific chemical in the FDA inventory does not guarantee that a food additive is safe to eat, nor does it mean that the compound is dangerous. But the site is useful in that it provides a central clearninghouse for basic information on the astonishing range of chemicals that can end up in our processed, packaged, and pre-made foods.

"It is important to note that the Substances Added to Food inventory is only a partial list of food ingredients," the FDA itself indicates, adding that "inclusion in this inventory of information from non-FDA entities does not indicate an FDA approval or evaluation of this use."

In cases where the Substances Added to Food inventory contains information provided by non-FDA entities––like the Environmental Protection Agency, for instance––FDA approval, or even evaluation of a substance's permissible uses, cannot be presumed.

Anyone using the food inventory should be aware that inclusion is not necessarily a marker of FDA acceptance or even comprehensive safety testing of a particular substance. The database contains not only evaluated and approved food ingredients––but also additives that might still be under safety review.

For practitioners or patients seeking specific safety or health risk details about particular food-related colorings, flavorings, preservatives, or pesticides, this FDA database is undoubtedly a useful health information tool. Though it is not likely to be the final word on the safety (or lack thereof) of particular food additives, it does provide a solid starting point.


Is the Time Right to Revise DSHEA?

By Erik Goldman, Editor

The Dietary Supplement Health and Education Act (DSHEA) has certainly had its share of critics over the 25 years since it was signed into law by then-President Bill Clinton.Some contend the regulation is weak, and that it gives the supplement industry too much latitude, while providing too little consumer protection. On the other side, many argue that the law puts a stranglehold on truthful communication about supplements. Is the time right to revisit--and revise--this landmark law?

American Botanical Council Leads Initiative to End Adulteration of Herbs

By Erik Goldman, Editor

Call it the Eleventh Commandment: “Thou Shalt Not Commit Adulteration!”

Though it may not quite be a divine decree, the elimination of contaminants and adulterants is an imperative that conscientious herbal supplement companies are taking very seriously these days, as the American Botanical Council spearheads a major drive to tackle the problem.