This Update Brought To You By The U.S. Hemp Roundtable

According to the U.S. Hemp Roundtable and originally reported by Dallas/Fort Worth's NBC5, the Tarrant County District Attorney's office has already arrested a user of CBD in Fort Worth and intends on arresting more, noting that the law states that CBD is illegal without a prescription in Texas. NBC5, in its investigation, also noted that use of CBD in the county is widespread, even amongst law enforcement. This news has caused waves in the hemp industry, especially for those in Texas that sell CBD at retail.

The U.S. Hemp Roundtable issued a call-to-action shortly thereafter, making those who follow them aware of the developments and asking for residents of Texas to write their state legislators to encourage them to pass a bill legalizing the use of CBD without a prescription. They also shared a letter that they sent to the Tarrant County District Attorney's office asking for a hold on prosecution until the legislature had weighed in, noting that a bill was likely forthcoming.

Following the release of this news, the U.S. Hemp Roundtable also issued an alert today that notes that State Rep. Tracy King has introduced a bill into the state legislature that would legalize CBD and hemp-derived products today. The full bill is available to read online.

The developments in Texas offer some insight into the legal hurdles our retail members that choose to carry CBD and hemp-derived products face, both in Texas and abroad, and we hope that this information helps to further educate you on the issues facing you and your business, whether hemp-related or not.

 An excerpt of the letter shared by the U.S. Hemp Roundtable is below.

The FDA is reevaluating its regulations—and you can be a part of the process

On Monday, FDA Commissioner Scott Gottlieb, M.D., issued a statement that, in broad strokes, signaled to the natural products industry that changes were in the pipeline. He spoke of "bad actors ... exploit[ing] the halo" of the important and responsible manufacturers and retailers of natural products of all kinds, which, in the atmosphere we seem to be living in, can be alarming.

Clues as to the extent of this action can be found in the letters issued to a number of supplement manufacturers discussing their labeling and their violation of the regulations established by DSHEA in 1994. A number of the warnings issued related directly to claims of cures and treatments when, strictly speaking under the law, those products were not tested, verified, or authorized to treat or cure any such disease.

Taken in context with Commissioner Gottlieb's statements, which to both our eyes and to the eyes of our colleagues at AHPA seem to be considerate to the industry at large and aggressive to the aforementioned "bad actors," it seems that the FDA wishes to uphold the balance of DSHEA, improve the safety of all Americans, improve the natural products industry, and update the regulations to keep pace with our faster world.

Additionally, they have invited the industry to be participants in the discussions surrounding the regulatory actions, meaning that the same responsible manufacturers, retailers, and distributors that Commissioner Gottlieb described as having "halos" have a role to play.

It's been 25 years since DSHEA, and at this moment, it looks like the FDA is willing to reevaluate the regulations to maintain the balance struck by that law, and invites the industry to take part in shaping this new direction.

We will continue to follow this development for any major changes or shifts and keep you informed.

Commissioner Scott Gottlieb, M.D., Is Resigning

At approximately 3 p.m. E.T. on Tuesday, March 5, FDA Commissioner Scott Gottlieb, a champion for strong causes that often ran lockstep with a large part of our industry, resigned today as stated by the White House. According to the Washington Post, his resignation was not requested by any administration officials and that Gottlieb resigned to spend more time with his family.

The Washington Post also notes that Commissioner Gottlieb led the FDA through some of its most active steps, a sharp contrast to the ebbing of other agencies, like the EPA, over the past two years and actively sought new solutions to age-old problems both within our industry and within the food and drug industry at large.

Recently, Gottlieb made comments about the use of hemp in supplementation and was widely regarded to be a friend to the industry (with caveats), aiming to make our industry better for us by removing bad-faith actors and better for the public by increasing both the safety of supplements and public confidence in them. As we stated in an earlier Speedy Update, he took action against a number of companies in our industry that were skirting the regulations and acting outside of the law while acknowledging the numerous good-faith actors within the industry.

Gottlieb’s resignation takes effect a month from today. No news has yet emerged about a successor or what that means for our industry or for the food and drug industries he was charged with regulating and overseeing.

 We at SENPA will be watching this development closely for any effects to our industry and will be sure to update you as more details become available.

Trump Administration Names Ned Sharpless Acting Commissioner of the FDA

On March 12, 2019, the Trump administration named Mr. Ned Sharpless, director of the National Cancer Institute, to the position of Acting Commissioner of the FDA. The news, broken by Fox Business and reported by the New York Times, the Washington Post, the Hill, and others was confirmed by Health Secretary Alex Azar.

Sharpless, according to Azar, will be a "strong leader" for the FDA and that under Sharpless' watch, "there will be no let-up in the agency's focus," namely around how food safety is handled and the rising teen nicotine problems.

The news is no surprise to industry officials and news organizations, seeing as Gottlieb himself noted that Sharpless plays on a basketball team with some of the FDA's medical review board. His history with the organization goes a ways back, and he has interacted with the FDA on both personal levels, as stated before, and professional matters, such as G1 Therapeutics' and HealthSpan Diagnostics' dealings before the administration.

While his more medical establishment chops are well-known, not much has been reported on his stance on the natural products industry. However, with the commitment to furthering the causes the FDA pursued under Commissioner Gottlieb, the future seems at least a bit more certain.

We will, of course, continue to watch these developments and inform you of any changes or updates that affect our industry.

FDA Starts Working Group on CBD; Issues Warning Letters to CBD Manufacturers Making "Egregious" Claims

On Tuesday, the FDA sent warning letters to CBD companies that were making “egregious medical claims” about their products. Additionally, they announced a working group for a solution to adding CBD to foods, supplements, and cosmetics within FDA guidelines and with their approval.

These letters and this announcement of a working group is well within the pathway outgoing commissioner Gottlieb has followed before. In a recent SENPA Speaks Speedy Update, we informed you of warning letters sent to other companies for other “egregious medical claims” about their products. The FDA is seemingly enforcing their role as a regulator while also opening pathways to legally and ethically market their products within that regulatory framework.

This is also a step forward from December, 2018, when the FDA effectively banned CBD-infused foods and dietary supplements, citing the authority of the Federal Food, Drug, and Cosmetic Act. When that statement was issued (along with its own set of warning letters), the future of CBD-infused products seemed a little dimmer.

Yesterday’s announcement added some much-needed clarity to the pathway forward for products such as these, which some of you may choose to carry at your stores. Combine this with the increasing number of bills being proposed to legalize CBD at the state level, and the outlook seems to be stabilizing around a cautious, but steady, pace towards security.

We continue to monitor these efforts and will update you as news breaks.

Texas, Oklahoma Pass Bills Legalizing CBD Sales

According to the Dallas Morning News, the Texas House of Representatives has passed H.B. 1325, which allows farmers to cultivate industrial hemp and, notably, legalizes CBD with less than .3% THC content. Simultaneously, an amendment to Oklahoma S.B. 238 has created not only a bill that discloses the CBD’s country of origin and natural status, but also allows for CBD sales without a license—a big victory in that state for proponents of CBD.

The Texas bill, as we’ve spoken about in the past, is a huge step for Texas to allow these supplements statewide and secures a spot for retailers who choose to sell the hemp-derived supplement and for those who choose to use it. It wasn’t long ago that NBC 5 Dallas/Ft. Worth highlighted the risks by profiling a young man arrested for use of the substance, and the Sheriff’s stance on the supplement. Now the future of the supplement (and those who sell it or use it) is one step closer to being a stable, secure thing.

 In Oklahoma, the situation is a little different. Senate Bill 238 started its life as a bill requiring disclosure of the country of origin of the CBD in the product, and whether it was synthetic or naturally sourced. Thanks to an amendment made to the bill during the legislative process, it now contains language specifically legalizing CBD sales without a license. The Oklahoma House has approved the bill 99-1 and continues to the Senate sponsor.

Regardless of your stance on the controversial supplement, these bills will have an impact on our industry. We wanted to make you aware of these developments, and as always, we will bring you more information as it arises.

Thanks to the U.S. Hemp Roundtable for the information on the bills!

Florida Senate Passes S.B. 1020, Passes Hemp Legalization Onto Gov. DeSantis

The Florida State Senate voted today to approve S.B. 1020 as amended by the House and sent that bill onto Gov. DeSantis for a signature, who is expected to sign—beginning the final stages of approval for the industrial cultivation and application of hemp and hemp-derived cannabinoids such as CBD in Florida.

For those who sell, create, or otherwise engage in the emerging CBD market, this is the security they've been seeking. The text of the bill itself has language explicitly allowing the sale and use of foods, cosmetics, and CBD itself as non-adulterated substances, as well as establishing licensing and safety models to ensure that the supplement on the shelf is what it's supposed to be.

The bill is largely based off model legislation drafted and supplied by the U.S. Hemp Roundtable, a staunch advocate for industrial hemp legalization in the United States. Other bills in other states such as Texas are also basing their legislative pushes on that model language, as we've told you about before.

As always, as news breaks, we'll update you on the newest information on laws and regulations surrounding the industry.

Farm Bill, Including Legalization of Industrial Hemp, Passes the Senate

It's come to our attention that both Vitamin Retailer and The Washington Post are reporting that the Farm Bill of 2018 has passed the Senate in an 87-13 vote and is making its way to the House of Representatives, where it is also expected to pass as early as this week.The bill includes the legalization of industrial hemp and means a bright and shining future to the burgeoning hemp and CBD industry, which we know many of you, our members, are a part of.

On September 25, the Information Technology & Innovation Foundation (ITIF) filed a citizen's petition to the FDA against the NON-GMO Project asking to prohibit the use of the butterfly logo and packaging language stating it "deliberately deceives and misleads consumers" by misbranding. ITIF "request that the Commissioner of Food and Drugs issue regulation to prohibit the use of the term "Non-GMO" on consumer foods and goods, and to require distributors of foods and goods to revise their labeling to omit any "Non-GMO" term or claims."

ITIF goes on to claim the definition of Non-GMO, by the Non-GMO Project, "is not scientifically defensible". "It seeks to draw a distinction between something done deliberately by humans and something that occurs spontaneously in "nature" ", while ITIF stance is that "techniques used to bioengineer crops and livestock to produce foods were discovered as natural phenomena".

The Non-GMO Project, Bellingham, Wash., issued a statement in response: "The petition to the F.D.A., filed by the Information Technology and Innovation Foundation, a biotech-backed think tank, is based on errors and misrepresentations. While it's not surprising that this organization opposed the public's right to know whether or not their food contains G.M.O.'s, the petition is factually inaccurate and fundamentally biased. We do not expect the petition to gain traction with the F.D.A."

legislative updates 

SENPA's Mission and Vision Statement

SENPA's mission is to support the natural products industry through education, networking and advocacy for the right to buy and sell natural products by empowering healthy choices and business development.

SENPA strives to be the preferred resource for education, networking & advocacy in the natural products industry.

SENPA Inc.    727-846-0320