Category: Dietary Supplements

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.

FDA Commissioner Says Kratom Unsafe

Posted on by Patrick Morin

According to FDA’s Commissioner “anyone consuming kratom may be placing themselves at a significant risk of being exposed to salmonella.” This comes after a months long investigation by FDA and CDC into a salmonella outbreak that was traced to kratom products sold by various marketers and re-sellers. The FDA concluded that “anyone consuming kratom may be placing themselves at a significant risk of being exposed to salmonella.” To read the full press release, click here.

Kratom is not legally marketed in the United States as a drug or dietary supplement. Kratom is an considered an opioid by FDA. It is addictive and has been linked to many severe health consequences and several deaths. In a previous post, we noted FDA’s crackdown on kratom sellers believed to be sources of salmonella-tainted products.

Mitragyna speciosa, commonly known as kratom, is listed as a controlled substance in 16 countries. Two of those countries, Thailand and Malaysia, are among kratom’s native countries of origin. In addition, six states — Alabama, Arkansas, Indiana, Tennessee, Vermont and Wisconsin — have banned the substance; several more have legislation pending.

Morsel Law is actively investigating businesses involved in the sale, manufacturing and distribution of kratom in order to seek justice for were unjustly deceived and mislead. If you relied on false and misleading health claims about the benefits of kratom, you should contact our law firm. You may be entitled to compensation by filing a lawsuit and our attorneys can help!

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FDA Issues Additional Warnings to Kratom Sellers

Posted on by Patrick Morin

Last week the FDA issued a statement continuing to warn consumers not to use products containing kratom. FDA Commissioner Dr. Scott Gottlieb stated “[d]espite our warnings that no kratom product is safe, we continue to find companies selling kratom and doing so with deceptive medical claims for which there’s no reliable scientific proof to support their use.” A major concern for the agency is that sellers continue to make claims that kratom can cure opioid addiction. Gottlieb noted that “we cannot allow unscrupulous vendors to take advantage of consumers by selling products with [these] unsubstantiated claims.”

As part of their crackdown on kratom, the FDA issued Warning Letters to three marketers and distributors — Front Range Kratom of Aurora, Colo., Kratom Spot of Irvine, Calif., and Revibe Inc. of Kansas City, Mo. The letters referenced more than 65 kratom products, including Maeng Da Red Vein Powder, Red Thai Kratom Powder, 50X Black Diamond Extract, Super Elephant, White Sumatra and Borneo White Vein Kratom Powder.

As we mentioned in an earlier article, the FDA issued a health advisory that warned consumers not to use the botanical substance kratom, which the agency said “affects the same opioid brain receptors as morphine” and “appears to have properties that expose users to the risks of addiction, abuse and dependence.”

Mitragyna speciosa, commonly known as kratom, is listed as a controlled substance in 16 countries. Two of those countries, Thailand and Malaysia, are among kratom’s native countries of origin. In addition, six states — Alabama, Arkansas, Indiana, Tennessee, Vermont and Wisconsin — have banned the substance; several more have legislation pending.

Morsel Law is actively investigating businesses involved in the sale, manufacturing and distribution of kratom in order to seek justice for were unjustly deceived and mislead. If you relied on false and misleading health claims about the benefits of kratom, you should contact our law firm. You may be entitled to compensation by filing a lawsuit and our attorneys can help!

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Importing Dietary Supplements? What You Need to Know

Posted on by Patrick Morin

Dietary supplement products that are destined for importation into the United States and for marketing to U.S. consumers are governed by a complex body of federal laws and regulations. These laws and regulations establish requirements that pertain to product manufacturing practices, product and ingredient safety, product labeling, marketing claims and product importation procedures, among other matters.

If you plan to import supplements into the U.S. and don’t know where to start, below is a checklist of items to consider.

Ingredients

  • Check the ingredient list for non-permitted ingredients and/or colors, or colors that require certification
  • Check ingredient name for the proper declaration

Label Format

All labels should include, at a minimum the following items:

  • Statement of Identity
  • Net Quantity
  • Supplement Facts
  • Ingredient List
  • Manufacturer, Packer, Distributor name and address
  • Country of Origin

Ingredient Permits

Do any of the ingredients of animal-origin requiring a permit (APHIS/USDA)?

Low-acid or acidified canned food

Is the product a low-acid or acidified canned food (pH/water activity) requiring additional process filings with FDA?

Claims

Claims are a common red flag for FDA/Customs inspectors. Make sure to review any disease or health claims for compliance with applicable regulations.

Facility Registration

Make sure the facility that manufactures the product is registered with FDA prior to importation to avoid delays.

Prior Notice

Each shipment requires a prior notification to be filed with FDA before the product arrives at its port of entry. Failure to file the prior notice in a timely manner can result in customs refusing entry of your shipment.

If you are unsure if the dietary supplements you plan to import comply with FDA regulations, contact our import specialists at Morsel Law for a FREE consultation.

If you poke an alligator with a stick, expect to get bitten!

Posted on by Patrick Morin

Now I know it can be frustrating when someone says “no,” but even my grade school-aged children know better than to respond “well, I’m going to do it anyway.” This is even more so when the person saying no is in a position of authority (i.e., dad). However, not all of us remember the lessons of our childhood and because of that some pay for the consequences of their actions. As such, I expect some FDA enforcement actions will be forthcoming soon.

Two days ago the FDA notified Industrial Chemicals, LLC (and it’s related company INI Botanicals) that it must advise the FDA on its intention to launch its product Mitrasafe, a product containing an extract of mitragynine (i.e., kratom). If that wasn’t enough, FDA Commissioner Scott Gottlieb, M.D. issued a press release noting that Industrial Chemicals’ “claims are unproven and dangerous” and the FDA intends “to take appropriate steps to protect the public health against kratom products that try to circumvent the law.” My interpretation…you just poked the gator, now get ready for its bite!

So how did this situation come about? The FDA previously denied Industrial Chemicals’ request for Mitrasafe to qualify as a new dietary ingredient and notified them that the FDA considers the product an unapproved drug. However, Industrial Chemicals apparently didn’t like the answer they received and instead issued a press release stating that Mitrasafe is “a New Dietary Ingredient that has complied with notification and safety requirements.” In fact, their website is still up and running, advertising the product available for sale starting February 28th.

This is a pretty brazen statement since Industrial Chemicals is opening themselves up not only to FDA enforcement, but also false advertising claims enforced by the Federal Trade Commission. In fact, last month the FDA and FTC jointly issued warning letters to 11 marketers and distributors of opioid cessation products making drug claims similar to Mitrasafe. Industrial Chemicals’ actions may have even possibly exposed themselves to consumer lawsuits for unfair and deceptive advertising.

While Industrial Chemicals is now represented by an attorney (see letter from FDA mentioned above), it is unclear if they are being provided sound advice or if they are just ignoring counsel’s advice. But either way, I don’t expect things to end well for them.

When you’ve spent considerable time, effort and money on a idea or product, it can be hard to handle rejection. But just because a regulator stops you forward progress, it doesn’t mean the end. This being said, there are right and wrong ways to go about overcoming obstacles. In my experience, taunting a 5,000 lbs alligator (i.e., flagrantly disobeying an order) never works out favorably in the long run.

If you have questions about kratom or dietary supplements containing kratom, please contact us here at Morsel Law.

 

FDA Issues Health Advisory for Kratom

Posted on by Patrick Morin

The U.S. Food and Drug Administration (FDA) issued a public health advisory that warned consumers not to use the botanical substance kratom, which the agency said “affects the same opioid brain receptors as morphine” and “appears to have properties that expose users to the risks of addiction, abuse and dependence.” In addition to being used to treat pain, anxiety and depression, FDA Commissioner Dr. Scott Gottlieb noted, kratom is “taken recreationally by users for its euphoric effects” — in part because the substance “has similar effects to narcotics like opioids” — and carries “similar risks of abuse, addiction and, in some cases, death.”

Gottlieb also said, it was “very troubling to the FDA that patients believe they can use kratom to treat opioid withdrawal symptoms,” despite the fact that “there is no reliable evidence to support the use of kratom as a treatment for opioid use disorder.” Gottlieb stressed that there are “clear data on the increasing harms associated with kratom,” including a tenfold increase in the number of calls to poison control centers regarding kratom.”

In addition, the FDA has received reports of 44 deaths associated with the use of products containing kratom, and use of the products has been associated with seizures, liver damage, withdrawal symptoms and other serious side effects. Gottlieb stressed, “there are currently no FDA-approved, therapeutic uses of kratom.”

The FDA public health advisory warns consumers not to use any products labeled as containing kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine.

This isn’t the first time the FDA has taken action to prevent kratom from distributed and sold to consumers. The FDA issued an Import Alert in 2012 for kratom as an unapproved drug and an Import Alert in 2014 for kratom containing dietary supplements. The FDA has worked with U.S. Marshals Service to seize kratom products from several U.S.-based businesses, including 25,000 pounds of raw kratom, 90,000 bottles of dietary supplements containing kratom, and 100 cases of products containing kratom.

Kratom is listed as a controlled substance in 16 countries. Two of those countries, Thailand and Malaysia, are among kratom’s native countries of origin. The botanical also is sourced from Indonesia and Papua New Guinea. In addition, six states — Alabama, Arkansas, Indiana, Tennessee, Vermont and Wisconsin — have banned the substance; several more have legislation pending.

If you have questions about kratom or dietary supplements containing kratom, please contact us here at Morsel Law.