Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2018/ucm592903.htm
Timestamp: 2019-01-22 11:09:14
Document Index: 271571301

Matched Legal Cases: ['§ 321', '§ 45', '§ 321', '§ 331', '§ 352', '§ 331']

Healthy Healing dba Crystal Star 1/11/18
Healthy Healing, LLC dba Crystal Star
Attn: Dr. Linda Page
9821 Valley View Rd
Eden Prairie, MN 55344-3527
RE: 543429
Dear Dr. Page:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address, www.healthyhealing.com, in December 2017 and has determined that you take orders there for the product “Withdrawal Support” (formerly “Addiction Withdrawal”). FDA also reviewed the product label for your “Withdrawal Support” product. The claims on your website and product label establish that this product is a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act. You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov. In addition, the Federal Trade Commission has reviewed your marketing claims for “Withdrawal Support” for potential violations of Sections 5 and 12 of the FTC Act, 15 U.S.C. §§ 45(a) and 52.
Examples of some of the claims observed on your website and product label that provide evidence that your product is intended for use as a drug include the following:
“Lifestyle therapies help relieve withdrawal by minimizing the discomfort…”
“Encourages the relief of symptoms like cravings, moodiness, nervous tension, head and backache.”
“Who is Crystal Star Addiction WithdrawalTM For?”
“People looking for a safe and natural product to help relieve symptoms like cravings, moodiness, nervous tension, head and back aches, and fatigue.”
“How can Addiction WithdrawalTM Enhance Your Health Program?”
o “Superior nervine herbs…help reduce cravings, and counter symptoms like agitation, nervousness, and irritability.”
“Skullcap…considered the superior herb for helping reduce addictions…”
“Wood Betony…helps reduce cravings, agitation and irritability. Relieves headaches.”
o “support craving reduction” (sic)
On the product page for Withdrawal Support:
Your product “Withdrawal Support” is not generally recognized as safe and effective for the above referenced uses and, therefore, this product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
Your product “Withdrawal Support” is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for their intended purposes. Accordingly, “Withdrawal Support” fails to bear adequate directions for its intended uses and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. § 331(a)].
In addition, the Federal Trade Commission has reviewed marketing claims related to opiate withdrawal and/or opiate addiction for “Withdrawal Support.” The FTC Act requires that health-related claims, such as claims that a product will treat or cure a disease or other health condition, must be supported by competent and reliable scientific evidence at the time the claims are made. In other words, it is against the law to make health claims, whether directly or indirectly, through advertising, the use of a product name, website name, or any other means, without adequate scientific support, or to exaggerate the benefits of products or services you are promoting. Violations of the FTC Act may result in legal action in the form of a Federal District Court Injunction or an Administrative Order and may require that you pay money back to consumers.