FDA Warning Letters

FDA, FTC Take A Swipe At Opioid Addiction Schlock

This morning the  U.S. Food and Drug Administration, or FDA, and the Federal Trade Commission, or FTC, issued joint warning letters to 11 companies the agencies allege are pushing unproven, illegal remedies for opioid addiction and withdrawal.

In a joint statement published this morning, Acting FTC Chairman Maureen K. Ohlhausen put it this way:  “Individuals and their loved ones who struggle with this disease need real help, not unproven treatments.” FDA Commissioner Scott Gottlieb agreed. “People who are addicted to opioids should have access to safe and effective treatments and not be victimized by unscrupulous vendors who are trying to capitalize on the opioid epidemic by taking advantage of consumers and selling products with baseless claims,” he said.

Formally warned about their unproven remedies were:

  • Opiate Freedom Center
  • U4Life, LLC
  • CalmSupport, LLC
  • TaperAid
  • Medicus Holistic Alternatives LLC
  • NutraCore Health Products, LLC
  • Healthy Healing, LLC
  • Soothedrawal, Inc.
  • Choice Detox Center, Inc.
  • GUNA, Inc.
  • King Bio, Inc.

Many of the products being peddled are specifically marketed to consumers looking for “natural” or “herbal” products. Most use customer “testimonials” to push their products and many make extensive use of social media.

Opiate Freedom Center, for example, offers what it calls The Freedom 5-Pack for $319.95. What do you get for all that money? A lot of B vitamins, some minerals and a few herbs like ashwagandha and chamomile–both of which are readily available for far less than 300 bucks:

Opiate Freedom Center's Freedom 5-Pack for drug withdrawal.

Opiate Freedom Center’s Freedom 5-Pack which promises “tried and true” information but which FDA and FTC say is bogus. Screengrab taken January 24, 2018 by Lisa Barger.

Considerably less expensive is NutraCore’s Detox Pro Health product which is essentially a mega-dose of B vitamins with some other vitamins, minerals, amino acids and a “proprietary blend” of ginger, milk thistle and valerian thrown in for good measure:

Opiate Detox Pro by NutraCore is not generally recognized as safe and effective for any of its touted uses.

NutraCore’s Detox Pro Health supplement, which FDA and FTC agree is making illegal and unproven promises to people fighting opioid addiction.

Even one of Lisa’s former professors, naturopath Linda Page, was warned for claims made about her company’s (recently renamed) Withdrawal Support product, which the company, Crystal Star, promised could ease withdrawal symptoms like headache, cravings and irritability:

Crystal Star's Withdrawal Support opioid withdrawal supplement.

Crystal Star’s Addiction Withdrawal product was recently renamed Withdrawal Support but FDA still called out herbalist Linda Page for claims.

In all, 11 companies were warned. Each has 15 working days to respond or face further action by either regulatory agency. And, of course, FDA is also asking physicians and consumers to report any illnesses or injuries that could be related to any of the products.