FDA Issues Additional Warnings to Kratom Sellers

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

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.