Author: Patrick Morin

Why you need a FSVP Plan?

Posted on by Patrick Morin
FSVP Plan

Before your products arrive in the United States, you must have a Foreign Supplier Verification Program (FSVP) Plan in place. If you don’t have a physical presence in the USA, then you need to then appoint an FSVP Agent to communicate with the FDA. However, there are a few things you need to know before you start drafting up an FSVP Plan and finding an FSVP Agent.

What is FSVP?

The FSVP rule is a requirement under the Food Safety Modernization Act (FSMA) which created as a preventive measure to prevent foodborne illnesses in the USA. FSVP rule is a way to ensure foreign food suppliers are following the same food safety standards as those required in the USA.

Who must comply with FSVP?

All importers who import food into the USA must comply with the FSVP. If you are a USA based importer and your food is coming from a foreign supplier, you must have an FSVP Plan in place before importing your products. If you do not have a representative in the USA, then you will need to appoint an FSVP Agent. The FSVP Agent must be physically located in the USA and will act as your company’s liaison with the FDA.

What happens if you don’t comply with the FSVP?

If you do not comply with the FSVP, you will not be allowed to import your food products into the US and they will be denied entry at the port.

What is an FSVP Plan?

An FSVP Plan is a document that describes the processes importers follow to ensure their foreign suppliers comply with FDA regulations. Without an FSVP Plan, the FDA can stop your products from being imported, even if your products are considered safe.

How can I obtain an FSVP Plan?

Only a “qualified individual” can develop an FSVP Plan. If you do not have qualified regulatory experts employed at your business then you will need to engage a firm to assist with the FSVP Plan process. If you need assistance or have question about complying with the FSVP rule please contact our specialists at Morsel Law.

Dietary Supplement Imports: Selling on Amazon Legally

Posted on by Patrick Morin
Dietary Supplement Imports for Sale on Amazon

Dietary supplement sales have surged the past few years as Americans have become more health conscious. Not surprising is that Amazon is the most popular platform where people look to purchase dietary supplements because of the convenience for both the seller and consumer. Businesses who desire to sell dietary supplements on Amazon should be familiar with the U.S. Food and Drug Administration (FDA) laws and regulations. Failure to comply with the FDA regulations will result in the removal of the dietary supplements from Amazon’s storefront.

FDA does not preapprove products for compliance, it is the business’ responsibility to ensure that the FDA requirements are met. Dietary supplements exported to the United States face extra requirements importers must follow. Below is a list of some of the FDA requirements for dietary supplement imports.

Facility Registration with FDA

All dietary supplement manufacturer’s facilities must be registered with the FDA if the product or ingredients are being exported to the United States. These foreign food facilities are required to identify a U.S. Agent for communications with the FDA at the time of registration. The FDA also requires that all food facilities renew their registration between October 1st and December 31st of each even-numbered year.

FDA Prior Notice

The FDA requires that a notification is filed for each shipment destined for a U.S. port prior to arrival. Failure to file a Prior Notice with the FDA will result in the shipment being denied entry into the United States.

FDA Labeling Requirements

Dietary supplement labels must list several items such as net weight, statement of identity, directions for use, warnings, company contact information, supplement facts and ingredients, among other things. Failure to comply with FDA labeling rules will result in the product being refused entry into the United States and possible detention, plus fines and penalties.

FDA Claims

Making claims not in compliance with FDA regulations is one of the most common violations cited by the FDA for dietary supplement imports. Products cannot make any claims that the dietary supplement will cure, treat or prevent any diseases. Claims that do not comply with FDA regulations can result in both civil and criminal penalties, so it is important to be aware of the rules before making any product claims.

Foreign Supplier Verification Program

Dietary supplement importers must engage an agent physically located in the United States to verify their foreign suppliers compliance with U.S food safety laws. Importers must also develop a Foreign Supplier Verification Program (FSVP) plan to evaluate and perform “risk-based activities” on all suppliers. Compliance with FSVP is mandatory and businesses found in violation of the FSVP rule can face a variety of penalties, from seizure of the imported products to criminal prosecution. For more information on the FSVP rule, check out this article.

If you are selling dietary supplements on Amazon, or plan to start in the near future, don’t let all of this overwhelm you. At Morsel Law we can help keep you in compliance with U.S. FDA rules. From registering your facility with the FDA to filing an FDA Prior Notice to reviewing labels and claims to developing your FSVP Plan or serving as your U.S. based FSVP Agent. Contact us to set up a consultation.

Dietary Supplement Importers Must Verify Foreign Suppliers

Posted on by Patrick Morin
dietary supplement imports

Dietary supplement importers must engage an agent physically located in the U.S. to verify their foreign suppliers compliance with U.S food safety laws. In fact, in 2019 the FDA cited the lack of developing a foreign supplier verification program (FSVP) as one of the most cited violations for FDA registered facilities. For most businesses the FSVP deadlines for compliance have passed, so making sure you have your FSVP plan in place before you ship is critical. FDA requires importers to present their FSVP’s upon request.

The FSVP rule was issued by FDA after passage of the Food Safety Modernization Act signed into law in 2011. The FSVP rule requires importers to perform “risk-based activities” to verify that the food they bring into the United States has been produced in a manner that meets U.S. food safety standards.

One of the key elements of the FSVP rule for foreign dietary supplement importers or exporters with no employees located in the U.S. is the requirement to designate an “agent” to carry out FSVP responsibilities on behalf of the importer. The agreement with the agent must be in writing and the agent must be identified in U.S. customs paperwork submitted with each shipment.

The FDA cited numerous registered facilities for FSVP-related violations, including:

  • Failing to follow or maintain a FSVP plan
  • Failing to translate the FSVP plan into English
  • Failing to sign and date modification to the FSVP
  • Failing to make adequate assurances of a supplier’s food safety

There was a 17% increase in the number of FSVP violations in 2019 from 2018. This demonstrates FDA’s continued focus on ensuring the safety of dietary supplements and food products entering the U.S. supply chain.

So if you are exporting dietary supplements to the U.S. or a U.S.-based importer, I’m sure you are wondering how the FSVP rule applies to you. For starters you need to pay attention because compliance with FSVP is mandatory. Businesses found in violation of the FSVP rule can face a variety of penalties, from seizure of the imported products to criminal prosecution. The FDA is currently conducting regulatory audits of importers and has made this new initiative their priority. Fortunately, there is still time to put a FSVP plan in place.

If you have questions about FSVP, need to develop a FSVP plan or need to engage a U.S. FSVP Agent, please feel free to schedule a call with our attorneys at Morsel Law.

USDA Testing Requirements for Hemp

Posted on by Patrick Morin
usda testing requirements for hemp

As mentioned in a previous article, the U.S. Department of Agriculture (USDA) recently published its interim final rule on the establishment of a domestic hemp production. The rule considers products compliant as long as 0.3% THC or below is within the product’s distribution or range.  These rules provide for potentially problematic situations for growers, though they are not unexpected.

Pre-Harvest Testing

Within 15 days prior to anticipated harvest samples must be collected by a Federal, state, local or Tribal law enforcement agency (or designated official). These samples must then be sent to a DEA registered laboratory for testing.

For anyone who has had experience dealing with regulatory agencies, you probably know that waiting for an inspector is part of the game. So what if the “designated official” conducting the sampling takes longer than 15 days? This could result in significant ramifications to the grower. It is possible that sampling beyond the planned harvest date could result in tests higher in THC because cannabis plants convert cannabinoids to THC as they approach maturity and harvest. The results from the pre-harvest test could mean the difference between whether an entire crop is destroyed or not, so the stakes are high.

Acceptable THC Levels

The interim final rule considers products compliant as long as 0.3% THC or below is within the product’s distribution or range. The rule does include some wiggle room in the THC calculation. The distribution or range is calculated by its percentage of THC +/- its “measurement of uncertainty.” This means that a product could test slightly over that limit but still qualify as hemp. The rule states “[t]he method used for sampling from the flower material of the cannabis plant must be sufficient at a confidence level of 95 percent that no more than one percent (1%) of the plants in the lot would exceed the acceptable hemp THC level.” “Acceptable hemp THC level” means:

Acceptable hemp THC level. When a laboratory tests a sample, it must report the delta-9 tetrahydrocannabinol content concentration level on a dry weight basis and the measurement of uncertainty. The acceptable hemp THC level for the purpose of compliance with the requirements of State, Tribal, or USDA hemp plans is when the application of the measurement of uncertainty to the reported delta-9 tetrahydrocannabinol content concentration level on a dry weight basis produces a distribution or range that includes 0.3% or less.

When cannabis is tested, there is a margin of error of the precision of the result. This margin of error, or “confidence level,” must be reported in addition to the actual result. For example, hemp that contains .34% THC but has a +/-.05 measure of uncertainty based on the testing method has a distribution or range of .29% to .39%. Because .3% THC is within this range, the USDA would consider this product compliant.

Confidence Level

Not all testing laboratories will utilize the same testing procedures and protocols, thus the results may vary from one lab to another. This could also lead to laboratory shopping, where customers search for laboratories that provide “flexible” results that are not as precise. This could even incentivize laboratories to stay at that 5% margin of error than trying to minimize the margin.

Decarboxylation

The interim final rule requires that testing methods must include a validated testing methodology that uses post-decarboxylation (or other similarly reliable methods) where the “total THC concentration level” reported accounts for the conversion of Delta-9-tetrahydrocannabinolic acid (THCA) into THC. “Other acceptable methods” include gas or liquid chromatography. The reasoning behind this is that while THC is the chemical component responsible for the intoxicating effect of cannabis, THCA is a non-psychoactive compound having very different properties. When THCA is heated, it goes through a process called decarboxylation, thereby converting to THC.

Mitigation

So what do you do if the THC levels are outside the acceptable range? Technically the product is then not considered hemp and thus would be classified as marijuana which is still a Schedule I drug under Federal law. As a result, the entire crop would need to be destroyed by a person licensed by the DEA to handle Schedule I drugs. But this is a problem also for testing laboratories because they would be in possession of Schedule I drugs. There is no current provision for remediation of crops with higher THC levels, thus the interim final rule threatens farmers’ livelihoods, especially if they are not protected by crop insurance.

If your business has questions regarding hemp compliance, please contact our attorneys at Morsel Law to set up a free initial consultation.

USDA Interim Hemp Rule – What You Need to Know

Posted on by Patrick Morin
USDA interim hemp rule

The U.S. Department of Agriculture (USDA) recently published its interim final rule on the establishment of a domestic hemp production. The rule establishes a program under which states and tribal nations must submit plans to regulate the production of hemp. Since most people don’t enjoy reading more than 150-pages of regulatory jargon, we’ve highlighted some of the important information you may be interested in below.

How do state programs get approved?

State or tribal nations seeking primary regulatory authority over its respective hemp program, may now begin submitting plans for approval. The USDA will approve or deny proposed plans within 60 calendar days. If a State or tribal plan is revoked, producers in that jurisdiction can take shelter under the revoked plan for the remainder of the calendar year and will have a 90-day window to apply for a hemp producer’s license under the USDA plan.

What if your state doesn’t submit a plan?

For producers located in a state or tribal nation that do not submit a plan, they will be subject to USDA’s plan. These producers may submit an application for a hemp producer’s license starting on November 30 and ending on October 31, 2020. In subsequent years, the annual application period will be from August 1 to October 31. To apply, an applicant must provide contact information, a legal description of the hemp producer’s lot, a criminal history report and other information as may be requested.

What are the testing requirements?

A representative sample of the hemp must be physically collected and delivered to a DEA-registered laboratory for testing. The rule also requires a Federal, state, local or Tribal law enforcement agency (or designated official) to collect samples from the flower material from the plant and test for THC concentration within 15 days prior to the anticipated harvest.

What are the “acceptable” THC levels?

Plans must also include procedures for sampling and testing hemp to ensure it does not exceed an acceptable THC level. The rule considers products compliant as long as 0.3% THC or below is within the product’s distribution or range. The rule does include some wiggle room in the THC calculation. The distribution or range is calculated by its percentage of THC +/- its “measurement of uncertainty.” For example, hemp that contains .34% THC but has a +/-.05 measure of uncertainty based on the testing method has a distribution or range of .29% to .39%. Because .3% THC is within this range, the USDA would consider this product compliant.

THC levels above acceptable range

Plans that do not meet the “acceptable hemp THC level” must be disposed of in accordance with DEA regulations. This means the product must be collected by an authorized person and destroyed by a DEA-registered reverse distributor. The producer must then send documentation to the USDA confirming the product’s disposal. Hemp producers will automatically receive a negligence violation if their product contains more than 0.5% THC. Moreover, if any producer receives 3 negligence violations in a five-year period, the producer will be banned from hemp production for 5 years.

Producer reporting requirements

All producers must report all addresses and locations where hemp will be grown, including indoor growing facilities, along with the acreage of that land. Annual reports must be submitted by December 15 each year, which provides certain producer information, land information and test result reports.

Transportation of hemp across state lines

On a Federal level there are no restrictions. Under the rule, states and tribal nations cannot place restrictions on the ability for compliant hemp product to cross their respective borders lines. However, certain state and local law enforcement agencies have taken a different view, stopping and seizing hemp shipments discovered in their jurisdictions. For example, the Idaho State Police seized a shipment of over 7,000 lbs of industrial hemp traveling from Oregon to Colorado and the West Virginia State Police seized a hemp shipment destined for Pennsylvania.

Until state laws catch up with federal law, interstate transport of hemp remains a fundamental risk with real business implications to hemp producers and their customers. Re-routing shipments to avoid certain states adds to costs and, if delayed, may lead to spoilage and financial loss. Some ways to mitigate risk mat be providing truckers transporting hemp: (1) a lab certificate attesting to 0.3% or below THC content levels to eliminate confusion between hemp and illegal cannabis; and (2) a copy of the hemp cultivation license issued under the state, tribe, USDA plan, or the 2014 Farm Bill to dispel doubts regarding the lawfulness of the production.

If your business has questions regarding hemp compliance, please contact our attorneys at Morsel Law to set up a free initial consultation.


FDA Says CDB Oil Not Dietary Supplement

Posted on by Patrick Morin
FDA says no to CBD oil as dietary supplement

The U.S. Food & Drug Administration (FDA) issued a warning letter to Alternative Laboratories, a dietary supplement manufacturer based in Naples, Florida, that markets CBD oil under the “Green Roads” brand name.

The FDA letter notes that CBD is the active ingredient in the approved drug product Epidiolex and is designed to treat certain rare, severe forms of epilepsy. Further, the FDA also notes that significant clinical research investigations concerning the use of CBD have been made public, including investigations related to Epidiolex and Sativex, a drug for the treatment of spasticity due to multiple sclerosis (MS) that has been approved for use in 25 countries outside the U.S. The manufacturer of Sativex, GW Pharmaceuticals, has disclosed its plans to seek FDA approval.

This letter is one in an ever growing list of FDA and FTC enforcement related to CBD products. While we await regulatory rules on CDB use, companies operating in the space should remain vigilant and adhere to a compliance policy that reflects–for now–the reality of current regulations and restrictions.

CBD businesses may contact our attorneys at Morsel Law for legal guidance by scheduling an initial consultation here.

FTC Issues Warning Letter to CBD Sellers

Posted on by Patrick Morin
CBD sellers issued warning letters

While the FDA has been at the forefront of enforcement against sellers of cannabidiol (CBD) products, the Federal Trade Commission (FTC) weighed in last week issuing warning letters to three separate businesses. According the letters, the FTC warned the businesses that sell oils, tinctures, capsules, gummies and creams containing CBD, a chemical compound derived from the cannabis plant, that it is illegal to advertise that a product can prevent, treat or cure human disease without competent and reliable scientific evidence to support such claims.

Although the FTC did not publicly disclose the businesses, its press release indicates that each of the businesses advertised CBD products that treat or cure serious diseases and health conditions – like cancer, Alzheimer’s disease, autism, anorexia, and more. Multiple claims were also made regarding their products effectiveness as a painkiller, in one instance claiming that CBD “works like magic” to relieve “even the most agonizing pain” better than opioids.

The FTC has given these businesses 15 days to address the concerns in the warning letters and demonstrate the health claims are supported by “competent and reliable scientific evidence.” A failure to address the FTC’s concerns may result in legal action against the businesses, including injunctions and orders to refund money to customers.

The takeaway here for CDB product sellers, manufacturers and advertisers is that they must be diligent and careful when making claims in connection with their products. Making unsubstantiated claims about the treatment, prevention or cure of a disease will expose a business and its products to regulatory scrutiny and, in some case, regulatory action. This includes statements made on labels, websites, press releases and social media accounts.

Before you print labels or post something on Instagram or Twitter about your product, you should make sure to have it reviewed for accuracy and compliance. It’s cheaper to make corrections before you go to print, then to later find out that you made a mistake and have to trash 6 months worth of labels.

If you need assistance reviewing your claims, please contact us at Morsel Law to schedule your free consultation.

Whole-Farm Crop Insurance Now Available for Hemp Producers!

Posted on by Patrick Morin
Hemp fields

Last week, the United States Department of Agriculture’s (USDA) Risk Management Agency (which oversees federal crop insurance), announced the availability of whole-farm “coverage for hemp grown for fiber, flower or seeds” for the 2020 grow year. This coverage will be available to hemp producers who are in areas covered by USDA-approved hemp plans or who are part of approved state or university research pilot programs. Other producers cannot obtain coverage until a USDA-approved plan is in place.

A “Whole-Farm” policy insures all commodities on a farm, under one policy, against unavoidable natural causes of loss (e.g., hurricanes and other natural disasters). This type of coverage is most often seen with specialty crops and organic products. The coverage period is the duration of the grower’s tax year. More information on the program can be found here.

The 2018 Farm Bill amended the Controlled Substances Act to address how industrial hemp is to be defined and regulated at the federal level, and those modifications cleared the way for the Federal Crop Insurance Corporation to offer policies for it. The Farm Bill defines hemp as containing 0.3 percent or less tetrahydrocannabinol (THC) on a dry weight basis.

USDA’s Agricultural Marketing Service (AMS) is formulating regulations that will include specific details for both a USDA plan and a submission process for state plans. AMS expects to release the rules later this year. For more information on hemp production click here.

While the inclusion of hemp in whole-farm coverage is a significant step forward, there is still a long way to go before growers have the benefit of fully developed hemp crop insurance. Our legal team is committed to the hemp and CBD industry and is available to assist hemp growers, breeders, processors and retailers, in all stages of development.

Please contact us to schedule your FREE consultation today!

U.S. importers are you verifying your suppliers?

Posted on by Patrick Morin
foreign supplier verification program

The FDA took action against a U.S. importer who failed to establish procedures to verify food safety standards of their foreign suppliers. While investigating a salmonella outbreak that was traced back to a particular brand of tahini, FDA investigators visited the offices of the U.S.-based importer Brodt Zenatti Holdings LLC. To their surprise they discovered the importer had neglected to meet the FDA’s food safety requirements. As a result FDA issued the importer a Warning Letter and an Import Alert ordering detention of all associated tahini products.

The Foreign Supplier Verification Program (FSVP) rule was issued by FDA after passage of the Food Safety Modernization Act signed into law in 2011. The FSVP rule requires importers to perform “risk-based activities” to verify that the food they bring into the United States has been produced in a manner that meets U.S. food safety standards. Most importers were required to put in place FSVP programs by 2019, while some qualified small business have until 2020 to comply.

So if you are a U.S. food importer, I’m sure you are wondering how the FSVP rule applies to you. For starters you need to pay attention because compliance with FSVP is mandatory. Importers found in violation of the FSVP rule can face a variety of penalties, from seizure of the imported products to criminal prosecution. The FDA is currently conducting regulatory audits of importers and has made this new initiative their priority. Fortunately, there is still time to put a FSVP plan in place.

If you have questions about FSVP or need to develop a FSVP plan, please feel free to schedule a call with our attorneys at Morsel Law.

Buckwheat and Quinoa Whiskey?

Posted on by Patrick Morin
whiskey quinoa buckwheat

The Treasury Department’s Alcohol and Tobacco Tax and Trade Bureau (TTB) has proposed a new rule changing the definition of “grain” to include the seeds of the pseudocereals amaranth, buckwheat and quinoa. Under current regulations, whiskey is considered a grain spirit and, until now, “grain” has been limited to four specific crops: corn, wheat, rye and barley.

This proposed change could be quite beneficial to the creativity in the whiskey industry, as craft distillers constantly look for new ways to distinguish themselves from the competition. The public comment period for the proposed TTB regulation is open until March 2019. Once the comment period closes, the TTB will review comments and consider changes to the proposal. After that any changes are subject to approval by the Treasury Department.

If you have questions about TTB regulations, please contact us at Morsel Law.