Month: February 2018

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.

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!