Tag: FDA

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.

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.

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.

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.

FDA Steps Up Enforcement of Label Violations for Food Imports

Posted on by Patrick Morin

I previously posted an article discussing the importance of accurate labeling, especially for food importers. Labeling errors are one of the most common reasons products shipped to the United States are refused entry. If a product is found to contain a labeling violation, the FDA may deem the product “misbranded,” making it a prohibited act to distribute the product in the U.S. Once the FDA identifies one mistake on a businesses’ labels, the agency is more likely to stop this businesses’ products at the border in the future.

In March 2018, the FDA refused entry to over 150 food products attempting to enter the U.S. These food products from various countries throughout the world now cannot be sold in the U.S. in their current form due to labeling violations, so now importers are faced with a difficult business decision.

There are three things importers can do with the refused products. First, they may re-label each item with FDA compliant labels. This would require the importer to design, print and affix new labels to each item refused entry within 15 days’ of receiving the refusal notice. The tight time-frame to accomplish these tasks is very difficult for smaller single-item shipments and almost impossible for larger multi-item shipments due to the manpower it would take to complete the labeling, in addition to the cost a labeling specialist will charge to expedite revised labels.

Another option is to export the products back to their port of origin or another suitable country (e.g., Canada, Mexico). While the importer would retain ownership of the products, the additional shipping cost may exceed the value of the underlying products. The last option, and usually the option of last resort, is to destroy the products while under FDA supervision. This usually occurs when the cost to re-label or export exceeds the value of the products refused entry.

FDA previously announced their intention to focus on import violations, as demonstrated by the March refusal list and their commitment to enforcing labeling laws. In order to avoid the high costs and delays resulting from a labeling violation, it is best to have food labels reviewed for FDA compliance prior to shipping the products to the U.S. The cost of such reviews are minimal in comparison to the cost of fighting to get your seized products released or exported due to a labeling violation.

If your business is unsure whether a product label is in compliance with, or need assistance in adapting your label to meet, FDA regulations Morsel Law can help. Order your flat-free label review to make sure your food label is in compliance.

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 Label Review to Prevent Food Import Refusal

Posted on by Patrick Morin

Labeling violations are one of the leading causes of food import refusals to the United States. In fact, more than 7,000 labeling violations for food products were cited by the U.S. Food and Drug Administration (FDA) in 2017 alone.

If an imported food product is stopped by the FDA for a labeling violation they have three choices: detention, seizure or refusal of admission. None of these are good options for food importers. Know what to avoid to make sure this doesn’t happen to your business.

Below is a list of the top five labeling violations for food imports.

Nutrition information

 

More than 1,000 import refusals in 2017 were due to missing nutritional information. The FDA requires that most food and beverages are labeled with a specifically formatted nutrition facts panel. However, often import food labels include a nutrition facts panel from a foreign country. Unfortunately for the importer these panels don’t meet the FDA requirements and are therefore deemed misbranded under the law.

This will be even more important now that FDA has changed the Nutrition Facts panel to a new format. It is important to make sure you utilize the new format going forward to avoid potential labeling errors.

Ingredients

FDA requires that every ingredient included in a food or beverage be disclosed on the label in descending order of the prominence by weight. The FDA will not only review labels, but will sample products to ensure the labels are what they say they are, which is why it’s important to follow the rules when listing ingredients.

FDA regulations also require ingredients to be listed by specific  names. Imported food products, which often contain ingredients know by different names in their home country, frequently fail to list certain ingredients by the required name under FDA regulations.

Labeling in English

FDA requires that all information on labels appear in English. Labels may include other languages as well, but if a foreign language is used all of the information on the label must appear in that language as well.

Net Quantity

FDA requires a statement that provides the amount of food in a container or package. This statement must include both the U.S. and metric measurement and must be listed in the front of the package.

 

Manufacturer Name

The name and address of the manufacturer, packer or distributor must be listed on a food label. If the importer is not the manufacturer, or if the product is made for the importer, the name and address of the importer may be preceded by “Manufactured for” or “Imported by” if applicable.

 

If the FDA discovers that your food product has one of these labeling violations, the FDA will refuse entry or detain your product. This will end up costing you a lot of money and could potentially damage your relationships with buyers.

FDA is now also required to increase the number of routine inspections overseas at foreign food facilities. If a non-compliant label is found during an inspection, FDA can charge you to reinspect the facility to ensure the labels have been brought into compliance at a rate of $305 USD per hour.

Morsel Law can help assure your labels are FDA compliant through our label review service. Our experts will review and markup your labels to make sure they meet FDA regulations. Order your FDA import label review today and keep your import business running smoothly!

Label Reviews Are Critical For Food Importers

Posted on by Patrick Morin

I previously posted a similar article discussing the importance of label reviews for domestic produced products here. But a recent event reminded me to reiterate the importance of accurate labeling, especially for food importers. Non-compliant labels can cost you time, money and even your relationship with customers.

A few weeks ago, JFC International Inc. issued a voluntary recall for rice seasoning products shipped to the United States. Apparently, the recall was initiated after the company discovered the product was not labeled in English, which is required under U.S. law. Also, because the label was not in English, it is deemed to have failed to disclose allergens contained in the ingredients. Important to point out is that this isn’t JFC International Inc.’s first time being involved with a recall event; they issued a similar recall in 2016 for failing to label in English and undeclared allergens.

This event is an important illustration of how important it is to review your labels prior to shipping your products to the United States. First, one of the most common misbranding mistakes for imports is failure to label in English. This seems like a simple fix, but you would be surprised how often this occurs. Importers should require the shipper to forward a copy of the label prior to shipping to confirm compliance with U.S. law. Now this won’t stop mistakes by workers at the warehouse who load the EU labeled products onto a pallet instead of the U.S. bound product, but if you include language in your contract that makes the shipper responsible for all costs to correct the misbranding in the event the wrong product labels are attached, they will quickly change their quality control practices. This is especially true for shippers who have had to foot the bill after a container is stopped by U.S. Customs.

Second, does a voluntary recall trigger coverage under your product recall insurance policy? Generally, coverage isn’t triggered unless there is an “actual” contamination, which is usually proved by product testing or other evidence. For JCF International, if the recall was initiated for misbranding due to failure to label their products in English, the coverage would be denied. However, because the product contained “actual” allergens, then coverage would probably be triggered. But if the product didn’t contain allergens, then coverage would be denied. Even if the product didn’t contain allergens the company would still need to recall the product because it is still considered misbranded and in violation of the FDC Act, but the recall would potentially result is significant non-reimbursable expenses.

Most food label misbranding violations can be prevented through quality control measures. Importers should, if they have not already, institute best practices to minimize the risk of a potential violation that result in having to respond to FDA Notice of Action letter. These practices should also address who bears the cost and burden to deal with a misbranding violation. Prior planning can help ensure your business identifies and minimizes potential risks commonly associated with the food import industry.

If you have questions about labeling, contact our attorneys at Morsel Law.