SENPA is doing its best to link members to resources about COVID-19, and keep them informed of any changes or effects that the pandemic may have on their businesses. 

Below you will find links to resource pages from the Center of Disease Control and Prevention (CDC), Infectious Disease Society of America (IDSA), and the World Health Organization; visit each website to stay informed with updated articles and notices concerning the virus. 

Center of Disease Control and Prevention

https://www.cdc.gov/coronavirus/2019-ncov/index.html

Infectious Disease Society of America.

https://www.idsociety.org/public-health/COVID-19-Resource-Center/ 

World Health Organization 

https://www.who.int/emergencies/diseases/novel-coronavirus-2019

Click here to see all websites and information pertaining to COVID-19 that SENPA has collected. 

SENPA Executive Director, Debra Short, just announced that the association will be working alongside its attorneys to create a live webinar on April 3^rd at 2:30pm ET for its members to answer all questions they may have pertaining to the Cares Act. AEGIS Law Managing Partners Rochelle Friedman Walk, and Scott Levine will be informing members on what resources are available to them under this new law, and how they can start accessing these resources. This means that SENPA members will have the ability submit questions concerning the Cares Act and their small business prior to the webinar to the attorneys free of charge. These questions will then be answered during the live webinar, with short follow-up consultations with AEGIS Law attorneys that can be arranged through email (for contact information on AEGIS Managing Attorneys view the closing contact section of this update ).

The webinar will focus on how small businesses can take advantage of the Paycheck Protection Program (PPP); a program created by the government to help combat some of the challenges that small companies could face due to COVID-19. PPP allows small businesses access to funds that will cover up to 8 weeks of payroll costs including benefits. These funds can also be used to pay interest on mortgages, rent, and utilities. Small businesses with 500 or fewer employees—including nonprofits, veterans’ organizations, tribal concerns, self-employed individuals, sole proprietorships, and independent contractors—are eligible. Businesses with more than 500 employees are eligible in certain industries. Starting April 3, 2020, small businesses and sole proprietorships can apply, then on April 10, 2020, independent contractors and self-employed individuals can apply. We encourage you to apply as quickly as you can because there is a funding cap.

Another option is to qualify for the U.S. SBA Economic Injury Disaster Loan (EIDL) with low interest 2.75% over 30 years. You must be able to demonstrate “substantial economic injury” directly attributed to the event according to the U.S. SBA EIDL guidelines.

Please fill out this link this to register for the webinar and submit your questions.

Here is the link for the PPP Document. Please fill this form out as soon as possible and try to submit it on April 3,2020. You can apply through any existing SBA 7(a) lender or through any federally insured depository institution, federally insured credit union, and Farm Credit System institution that is participating. Other regulated lenders will be available to make these loans once they are approved and enrolled in the program. You should consult with your local lender as to whether it is participating. All loans will have the same terms regardless of lender or borrower. A list of participating lenders as well as additional information and full terms can be found at www.sba.gov.

 AEGIS Law is an entrepreneur’s law firm, with a heavy focus on small to mid-size businesses. Ms. Walk has significant experience in representing consumer products companies and retailers, including retailers selling through e-commerce. She has served as our outside counsel for many years.

Mr. Levine has been an entrepreneur and works with businesses as well as venture funds. He is an active member of Entrepreneurs Organization in St. Louis and nationally.

To learn more about the firm, you can go to their two websites: www.Aegislaw.com or www.Walklawfirm.com.

For all other updates and questions concerning COVID-19 contact SENPA’s Executive Director Debra Short at 727.846.0320 or email dshort@senpa.org.

As always SENPA will continue to monitor all news pertaining to COVID-19 and the potential effects that the virus may have on SENPA members and their businesses, to stay informed on all breaking news visit SENPA.org .

In 2018, the federal Farm Bill effectively legalized the mass production of hemp, a cannabis plant containing less than 0.3 percent THC, the primary psychoactive component of marijuana. This bill allowed each state to create their own regulations.

Governor Ron DeSantis signed into law Senate Bill 1020 on June 25, 2019 establishing the Florida Hemp Program monitored by the Department of Agriculture (DOA). For the Florida Retailer this means that the State Hemp program removes hemp-derived cannabinoids, including but not limited to cannabidiol, as a controlled substance or adulterant under Florida law. Further, the Legislature has found hemp to be an agricultural commodity; thus, processing hemp for an end use will not be unlawful. Senate Bill 1020 places quality parameters on the distribution and retail sale of hemp extract. Each product must have a certificate of analysis prepared by an independent testing laboratory and the label states:

1. The hemp extract is the product of a batch tested by the independent testing laboratory.
2. The batch contained a total delta-9-tetrahydrocannabinol concentration that did not exceed 0.3 percent on a dry-weight basis pursuant to the testing of a random sample of the batch; and the batch does not contain contaminants unsafe for human consumption.

(b) “Is distributed or sold in packaging that includes”: A scannable barcode or quick response code linked to the certificate of analysis of the hemp extract by an independent testing laboratory.

1. The batch number.
2. The Internet address of a website where batch information may be obtained.
3. The expiration date. The number of milligrams of hemp extract; and a statement that the product contains a total delta-9-tetrahydrocannabinol concentration that does not exceed 0.3 percent on a dry-weight basis.

This means that retailers, not limited to Health Food retailers, should be prepared for inspection at anytime in concerns with Hemp extracts in their stores. Inspectors will be looking at the products on their shelves to make sure that they are in compliant with the new regulations under the Bill. Each retailer will be given 30 to 45 days to become compliant with regulations before penalties are issued. All retailers including Health Food retailers will be required to pay the Department of Agriculture $650 to sell products with CBD.

Most retailers are embracing the new regulations, while some who may not have a large inventory may see it challenging to discard items that are not in compliance with the new packaging requirements.

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

The FDA sent 15 companies warring letters this week, regarding allegedly selling products that contain cannabidiol in way that ..nolate the Federal Food Drug and Cosmetic ACT. The FDA stated that based on the lack of scientific information supporting the safety of CBD in food it cannot conclude that CBD is generally recognized as safe (GRAS). The FDA had primarily maintained CBD prohibited in comentional food products because substantial clinical investigations were initiated and made public on a drug containing CBD. FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed and plans to provide an update on its progress in the coming weeks.

A New public guidance for CBD consumers was also issued by the FDA, it highlights the concerns about possible health risk and stresses that it has “seen only on limited data about CBD safety”.

SENPA will continue to monitor any progress concerning this matter.

An analysis conducted by the American Herbal Products Association (AHPA) based on recall data from the Food and Drug Administration (FDA) found that 14 of 803 ( 1.7 percent) recorded recalls initiated in 2019 involved dietary supplements, among these, three were Class I recalls (the most serious recall class), according to an article published in the August 2019 AHPA Report.

“[The] Recall data provided additional evidence of the overall safety of the dietary supplement class,” said AHPA Chief Information Analyst Merle Zimmermann, Ph.D. “AHPA also regularly reviews other dietary supplement safety resources, including mandatory serious adverse event reports and recorded observations from FDA inspections, and the results suggest that current supplement laws and regulations are working effectively to protect consumer safety and ensure a marketplace of high-quality, safe products.”

The FDA is responsible for tracking and reporting product recalls, along with other regulatory activities. Reports Documenting these recalls are regularly distributed by the FDA and are available to the public through the internet Recall Enterprise System (IRES). AHPA’s analysis is based on IRES data released by the agency through June 26, 2019, which recorded 803 recall events initiated in calendar year 2019.

Of the 803 recalls recorded in IRES in this period, 29 percent were recorded for medical devices and 28 percent fir biological products. Drug products accounted for 18 percent of these recalls and 20 percent were for conventional foods. AHPA staff identified 1.7% of recalls involved dietary supplement products.

FDA assigns voluntary recalls a classification based on a health hazard evaluation:

• Class I — A reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
• Class II — Use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
• Class III — Use of, or exposure to, a violative product is not likely to cause adverse health consequences

Eleven of the 14 dietary supplement recalls (nearly 79 percent) from the reviewed period in 2019 were classified as Class II or Class III, and three (21 percent) were identified as Class I.

Among the dietary supplement recalls conducted in 2019 and classified by FDA between January 1, 2019, and June 26, 2019, the most common reasons for conducting a recall were the risk of microbial contamination (29%, 4 cases) or mislabeling, including incorrect amounts of ingredients and omitted excipients (21%, 3 cases), or the presence of unlabeled allergens, (14%, 2 cases).

During this same period, 162 recalls were conducted involving non-dietary supplement food products. Of these recalls, 45% (73 cases) regarded undeclared allergens or the presence of sulfur or sulfites and 26% (41 cases) were related to microbial contamination, manufacturing errors (usually involving foreign material in the product) were seen 16% of the time (26 times), and 7% (11 recalls) were based on mislabeling.

Among the 803 recalls analyzed, there were seven cases where FDA indicated that the recalled products were illegal drugs masquerading as dietary supplements and one where the illegal drug was labeled as a conventional food. All of these recalls were classified by FDA as Class I recalls, and have been separated from the other categories above. These illegal products are archived on AHPA’s Keep Supplements Clean website (keepsupplementsclean.org), a free resource to inform consumers, the dietary supplement industry, and other stakeholders of issues related to illegal, tainted products with false labels. In each of these cases, products were labeled as either conventional foods or dietary supplements, but when tested they were found to contain undeclared illegal drug ingredients. The regulated supplement industry continues to vocally support FDA’s using its existing authority to fully enforce current laws and regulations to remove these illegal products from the market.

This article is credited to AHPA and the FDA. SENPA is not the original author of this article.

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

Throughout the week, and towards the end of last week, states such as Florida, California, and New Jersey have made major announcements concerning CBD.

On Tuesday June 25, Florida Governor Ron Desantis signed SB 1020 into law, expanding Florida’s hemp program and explicitly legalizing the retail sale and possession of Hemp-derived CBD. Individuals can now carry CBD on their person without arrest.

On Monday June 24 , AB 228, a U.S Hemp roundtable-supported bill protecting the retail sale of hemp-derived CBD in California, which passed the house unanimously this spring, passed unanimously out of the Senate Business and Professions Committee where it was amended to provide for labeling and testing requirements for CBD products. The final step for before the senate floor is the Appropriations Committee, U.S Hemp Roundtable is hopeful that the bill will be fast-tracked. If you are from California, visit the California state Action Center to get in touch with your local legislation and urge for support of this bill.

Last week, Thursday June 20, New Jersey General Assembly unanimously passed A5322 a bill which explicitly legalizes the retail sale of hemp-derived CBD, using provisions from the U.S Hemp Roundtable’s Model State act. Specifically the bill declares that hemp products such as CBD “shall not be considered controlled substances,” and “may be added as an ingredient to cosmetic, personal care products, or products intended for human or animal consumption.” The Bill is now on Governor Phil Murphy’s desk and he is expected to sign it in the coming weeks.

This speedy update is credited to U.S Hemp Roundtable.

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

The U.S Food and Drug Administration announced today that it does not intend to object to the use of certain qualified health claims stating that consuming eicosatetraenoic acid (EPA) and docosahexaenoic (DHA) Omega-3 fatty acids in food or dietary supplements may reduce the risk of hypertension and coronary disease.

The FDA responded to a health claim petition submitted by The Global Organization for EPA and DHA Omega-3s in a letter of enforcement discretion. Enforcement Discretion means that FDA does not intend to object to the claim if it is used consistent with the factors described in the letter of enforcement discretion. The FDA determined that the overall evidence did not meet the “significant scientific agreement” standard required for an authorized health claim but did meet the “credible evidence” standard for a qualified health claim in the labeling of conventional foods and dietary supplements.

While there is some evidence suggesting that combined intake of EPA and DHA from conventional foods and dietary supplements may reduce the risk of hypertension by lowering blood pressure, this evidence is inconclusive and highly inconsistent. The FDA thoroughly reviewed the 717 publications cited by the petitioner, and considered other written data and information, including studies published after the petition was submitted and studies cited in public comments about the petition.

Under the FDA’s health claim regulations, food and dietary supplements that bear a health claim must meet requirements regarding levels of certain nutrient. These requirements and the enforcement discretion factors FDA intends to consider for the use of this qualified health claim are described in detail in the letter of enforcement discretion issued to the petitioner.One of these enforcement discretion factors is that dietary supplements and conventional foods labeled with the qualified health claim contain at least 0.8 g EPA and DHA (combined total) per serving.

To prevent consumer deception about the strength of the science underlying the new claim the qualified health claim must be accompanied by a disclaimer or other qualifying language that accurately describes the level of scientific evidence supporting the claim.

1. Consuming EPA and DHA combined may help lower blood pressure in the general population and reduce the risk of hypertension. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.
2. Consuming EPA and DHA combined may reduce blood pressure and reduce the risk of hypertension, a risk factor for CHD (coronary heart disease). However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.
3. a. Consuming EPA and DHA combined may reduce the risk of CHD (coronary heart disease) by lowering blood pressure. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.
   b. Consuming EPA and DHA combined may reduce the risk of CHD (coronary heart disease) by reducing the risk of hypertension. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.
4. Research shows that consuming EPA and DHA combined may be beneficial for moderating blood pressure, a risk factor for CHD (coronary heart disease). However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.

For more information contact SENPA. As always, as news breaks, we’ll update you on the newest information on laws and regulations surrounding the industry.

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.

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!

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.

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.

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.

On Monday, FDA Commissioner Scott Gottlieb, M.D., issued a statement that, in strokes, signaled to the natural products industry that changes were in the. He spoke of “bad actors … exploit[ing] the halo” of the important and manufacturers and retailers of natural products of all kinds, which, in 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 supplement manufacturers discussing their labeling and their violation of the established by DSHEA in 1994. A number of the warnings issued directly to claims of cures and treatments when, strictly speaking under law, those products were not tested, verified, or authorized to treat or cure any disease.

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

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

It’s been 25 years since DSHEA, and at this moment, it looks like the FDA is to reevaluate the regulations to maintain the balance struck by that law, 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 you informed.

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.

“…last December, the U.S. Congress passed, and President Donald Trump signed, the 2018 Farm Bill, which removes hemp-derived CBD – as well as all ‘extracts, cannabinoids and derivatives’ of the hemp plant – from the purview of the Controlled Substances Act.

Texas law is undeniably unclear about the status of hemp-derived CBD. There is no explicit prohibition for the retail sale of such products, nor admittedly is there any express permission for its sale. Indeed, there is no definition of ‘hemp’ under Texas law. However, while marijuana and THC are generally considered controlled substances under Tex. Health & Safety Code Ann. § 481.032 (Schedule I opiates) (25),(34), there is an exemption from control when these substances are “specifically excepted.” As discussed above, the 2018 Farm Bill removes, and therefore specifically excepts, hemp-derived CBD from drug control.”

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.”