FDA Issues Health Advisory for Kratom

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.

Are Your Beer Ingredients Exempt from TTB Formula Approval?

Craft brewers continue to experiment with a wide variety of non-traditional ingredients to concoct new and exciting beers. For example, Fulton’s HefeWheaties (a Wheaties-themed Hefeweizen), Oxbow Brewing’s Sasion Dell’Aragosta (brewed with live Maine lobsters and sea salt), Porterhouse Brewing Company’s Oyster Stout (you guessed it…made with live oysters!), and Short’s Key Lime Pie (made with fresh limes, milk sugar, graham crackers and marshmallow fluff). From these limited examples you can only imagine where brewers will go from here.

The use of new and novel ingredients in beer is not prohibited by the Alcohol and Tobacco Tax and Trade Bureau (“TTB”). However, if a brewer intends to use an ingredient in a beer that is not on the TTB exemption list, then the brewer is required to obtain formula approval (or a pre-import approval for imported beer) from the TTB.

In December 2015, the TTB issued Ruling 2015-1, which re-states and supersedes Ruling 2014-4, by adding more than 50 new ingredients exempt from the formula requirements, including ingredients such as tea, jasmine, rosemary, grapes and figs (a complete list of exempt ingredients is listed here). Although this new ruling has exempted many flavoring materials added to beer, including several fruits and spices, sugars, chocolate, tea and coffee, it does not (and cannot due to existing regulations) exempt flavorings and extracts, which continue to require formula approval prior to use. For example, while a brewer can add watermelon, strawberry juice, strawberry puree or strawberry concentrate to a beer without obtaining formula approval, adding a strawberry flavor still requires formula approval.

Ruling 2015-1 was issued by the TTB in response to a petition filed by the Brewers Association requesting to expand the list of exempt ingredients. Although the TTB did not exempt all the ingredients requested by the Brewers Association, the TTB remains open to future petitions regarding additional ingredients. A procedure for such a petition is located at 27 C.F.R. § 25.55(f).

If you have any questions about beer regulations or formula requirements please contact our attorneys at Morsel Law.

KIND Petitions FDA: Should Investors Lose Confidence in General Counsel?

In a previous article I discussed how important it is for food businesses to conduct an in-depth label review prior to launching new products. Specifically, I addressed the FDA Warning Letter issued to KIND LLC and pointed out how costly labeling mistakes can be, especially when the risk could have easily been mitigated. In their response to FDA, KIND agreed to correct most of the technical errors noted in the letter; however, when it comes to changing their view of what foods are allowed to label themselves as “healthy” they don’t agree with what they refer to as “outdated” regulations.

In a citizen petition letter (“Petition Letter”) sent to FDA last week, KIND’s general counsel, Justin Mervis, notes that under current regulations “whether or not a food can be labeled “healthy” is based on specific nutrient levels in the food rather than its overall nutrition quality.” KIND then goes on to claim that new scientific evidence no longer supports this view and that, accordingly, FDA amend 21 C.F.R. 101.65(d)(2) in regards to nutritional content claims so that manufacturers may use the term “healthy” without regard to the total fat or saturated fat, if the source of such fat comes from fruits, vegetables, nuts, seeds, legumes, whole grains or seafood, provided that “such foods are used in their whole form or have been processed in such a way that did not materially degrade their nutritional value.”

While the Petition Letter makes several other recommendations, the majority of the Petition Letter is devoted to the argument that there is a disconnect between the Dietary Guidelines and what claims manufacturers are permitted to state on their labels. KIND argues that manufacturers should be permitted to make claims on their products labels (e.g., “nuts are part of a healthy diet”) that are consistent with federal dietary recommendations and current scientific evidence. As such, KIND goes on to request the FDA “undertake rulemaking to define a “dietary guidance statement” as a statement in food labeling about the usefulness of a food, or a category of foods, in maintaining healthy dietary practices.” The requested rule would permit claims on food labels to communicate that certain foods are useful in creating a diet that is consistent with current dietary recommendations, so long as those claims are not misleading.

While it isn’t a secret that food regulations, in some part, have become “outdated”, what makes KIND’s petition interesting is it comes after being caught violating the same regulations they are petitioning to amend. The real question is whether KIND knew their product labels were non-compliant when released into the marketplace or did they make a business decision to move forward with non-compliant labels in order to promote their “healthy” marketing campaign. While the saying “it’s better to ask for forgiveness then to ask for permission” may apply in certain situations, it’s probably not the best strategy when it comes to breaking federal law.

The role of the general counsel is to advise executive leaders on the state of the law, how certain laws affect their business and to provide pertinent information and/or legal advice to such leaders so they have the ability to make informed decisions. The general counsel is not required to be an expert in the industry in which their client operates (although it certainly helps); however, they should know the limits of their expertise and, when appropriate, bring in outside assistance with such expertise. If they don’t know their limits, or can’t identify potential legal issues outside their expertise, then their departure should be swift. After all what good is legal counsel if leaders are not able to rely on their advice?

It isn’t clear whether KIND made the decision to market their products with non-compliant labels, but if they did the general counsel shouldn’t take the blame. However, it took KIND six months to file their Petition Letter which leads me to believe the labeling violations occurred not because of a strategic business decision, but due to the lack of regulatory expertise and oversight from the general counsel’s office. If my presumption is correct, investors should demand answers and push for changes in the executive suite. These violations have resulted in significant expense revising labels, advertising and websites, in addition to substantial legal fees incurred responding to the Warning Letter and submitting the Petition Letter, and most recently defending consumer lawsuits. While attorneys play a significant role in advising businesses, legal fees cannot be entirely avoided; however, they can be efficiently managed. It is up to KIND’s investors to decide whether their capital in this situation was well-spent.

Craft Brewers Should Prepare for FDA Inspections

“Whoa, hold on,” you say, “I’m a craft brewer. What does the FDA have to do with me?” Well, that’s a good question. As a brewer you are already familiar with your state liquor agency and the Tobacco, Tax and Trade Bureau (TTB), but what you probably don’t realize is that the Food and Drug Administration (FDA) also regulates your operations. With the increased focus on food safety, and additional regulations under the Food Safety Modernization Act (FSMA), it is only a matter of time until FDA comes knocking on your door.

“Okay, you’ve got my attention,” you respond. “So what part of my business does the FDA regulate?” Glad you asked. The FDA has jurisdiction over many aspects of your business, including both the inputs to and outputs of your operation. Below are just some examples:

Registration:

Just like food manufacturers, breweries are required to register as a food facility with the FDA and renew their registration every two years. This registration requirement applies regardless of whether you brew domestically or overseas (i.e., import beer into U.S.A.).

Labeling Requirements: 

Beer that contains both malted barley and hops are subject to TTB labeling regulations; however, beer that doesn’t contain both malted barley and hops (i.e., rice or wheat beer) are subject to FDA labeling regulations. These regulations require additional disclosures, including: ingredients (such as spices, flavorings, colorings, chemical preservatives); allergens, such as wheat; and nutritional facts (think of that dreaded word “calories”), of course unless it meets certain exemptions.

Good Manufacturing Practices (GMPs):

Federal regulations have established GMPs for the manufacturing, packing or holding of human food, which includes several of the steps in the beer-making process. Storing and holding grains and other food products for processing and beer for shipment is also subject to regulation. In order to comply with these regulations your operations need to be sanitary, you must perform an analysis of your operations to address any potential hazards, and implement GMPs to minimize such hazards.

Reporting and Record-keeping:

Food safety continues to be a primary concern of FDA and new regulations under FSMA. To ensure your brewery remains compliant you must keep records of the immediate sources of food and the immediate recipients of products you sell. In the event of food safety incident, such as the release of an adulterated product from a production, bottling or manufacturing facility, FDA may require the release be reported. These record will assist brewers and FDA in identifying the sources and recipients of the adulterated products.

Bulk Sales:

Bulk sales of foods and processing byproducts, such as spent grain for animal feed, are subject to FDA regulation. Brewers already implementing human food safety requirements would not need to implement additional preventive controls or GMPs for animal food, except to prevent physical and chemical contamination. This requirement applies even if you’re donating the byproducts for use in animal food.

Food Service and Sales:

In addition to selling beer, do you serve food or sell packaged food products, such as olive oils, cheese, meats or other snacks, in your tasting room or brewpub? Food products served or sold on premise may be subject to federal, as well as state or local, regulations. While exemptions that may apply, you should make sure you stay in compliance with the law.

Inspections:

Under the rules promulgated under FSMA, the FDA is obligated to inspect every brewery in this country over the next several years. This means the FDA can observe your manufacturing processes, inspect your facilities and every aspect of your operation. They also can review your records and take photograph your operations. You should be prepared for any kind of surprise inspection. Also, if the facility fails to meet compliance standards on the first visit to your brewery, FDA will reinspect at a later date and you will be charged at a rate of $221/hour.

As you can see, the FDA has quite a bit of regulatory oversight over your brewery. But it’s not too late to take action to ensure your brewery is compliance, as many of the food safety rules under FSMA have yet to take effect. If your brewery is unsure whether it is in compliance with, or need assistance in adapting your brewery to meet, FDA regulations please contact our attorneys at Morsel Law.