WARNING LETTER
Healthy Healing dba Crystal Star MARCS-CMS 543429 —
- Recipient:
-
Recipient NameDr. Linda Page
- Healthy Healing dba Crystal Star
9821 Valley View Rd
Eden Prairie, MN 55344-3527
United States
- Issuing Office:
- Center for Food Safety and Applied Nutrition
United States
| |
| DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION SILVER SPRING, MD 20993 |
WARNING LETTER
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
January 11, 2018
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:
Withdrawal Support
- “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.”
- On the product label:
o “support craving reduction” (sic)
Moreover, the claims quoted above are supplemented by the meta tags used to bring consumers to your website through Internet searches. The meta tags include:
On the product page for Withdrawal Support:
- “Relieve Your Symptoms…addiction, withdrawal, cravings.”
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.
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 C.F.R. § 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
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)].
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your product. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.
Unsubstantiated Advertising
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.
Given the claims you are making, you should be aware of two FTC law enforcement actions challenging unsupported claims for the treatment of opiate addiction and/or opiate withdrawal symptoms: FTC v. Sunrise Nutraceuticals, LLC, which involved the product Elimidrol, and FTC v. Catlin Enterprises, Inc., which involved the products Withdrawal Ease and Recovery Ease. The complaints and orders in those cases can be found at https://www.ftc.gov/enforcement/cases-proceedings/152-3208-x160006/sunrise-nutraceuticals-llc and https://www.ftc.gov/enforcement/cases-proceedings/1623204/catlin-enterprises-inc. The orders entered in both cases imposed monetary judgments and required the defendants to stop making deceptive claims.
The FTC strongly urges you to review all health-related claims that you and any of your affiliates are making in any medium. Competent and reliable scientific evidence for a product claiming to treat opiate withdrawal symptoms or opiate addiction consists of randomized, controlled, human clinical testing of that product. If any of your claims are not supported by competent and reliable scientific evidence, you should delete or revise them immediately.
With regard to the advertising claims discussed above, please notify Mamie Kresses of the FTC via electronic mail at mkresses@ftc.gov, within fifteen working days of receipt of this letter, of the specific actions you have taken to address FTC’s concerns. With regard to the FDA-related violations described in this letter, please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct the violations noted above. Your response should include any documentation that would assist in evaluating your corrections. If you cannot complete corrective action within fifteen working days, please explain the reason for the delay and the date by which you will make the correction.
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. You may respond in writing to Compliance Officer Shawn Goldman at U.S. Food and Drug Administration, 5001 Campus Drive, College Park, MD 20740.
If you have any questions concerning this letter, please contact Mr. Goldman at Shawn.Goldman@fda.hhs.gov.
Sincerely,
/S/
William A. Correll
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
/S/
Mary K. Engle
Associate Director
Division of Advertising Practices
Federal Trade Commission
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