Public Health Service Food and Drug Administration
New York District
158-15 Liberty Avenue
Jamaica, New York 11433
July 22, 2016
WARNING LETTER NYK 2016-38
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Brian Robinson, President
TPR Holdings, LLC
950 Third Avenue
New York, New York 10022
Dear Mr. Robinson:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.freeze247.com/ in May 2016 and again in July 2016 and has determined that you take orders there for the Freeze 24-7 Instant Targeted Wrinkle Treatment product. The claims on your website establish that this product is a drug under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(C)] because it is intended to affect the structure or function of the human body. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Examples of some of the website claims that provide evidence that your product is intended for use as a drug include:
Freeze 24-7 Instant Targeted Wrinkle Treatment
“A natural alternative to Botox® and other potentially harmful (and costly) Invasive procedures.”
“Gynostemma is a pure plant extract, which acts to help microcirculation, and assists GABA in communicating its muscle relaxation message.”
“Freeze 24-7® products incorporate our Age Less Technology which releases Topical Muscle Relaxers (TMRs).
“Freeze 24-7® products incorporate our patent-pending Age-Less Technology, ™ which includes the ingredient, GABA (Gamma Aminobutyric Acid). GABA is produced in the body as a natural muscle relaxant, just as melatonin is produced as the body’s natural sleep inducing agent. When used in conjunction with other key ingredients found within our proprietary complex, GABA works to help diminish the appearance of fine lines and winkles on the facial area quickly, safely, and effectively with no side effects – just results.”
“Offers alternatives to Botox, Restylane and other sometimes harmful, costly and invasive procedures.”
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the 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 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.
This letter is not an all-inclusive statement of violations associated with your products or their labeling, and we have not attempted to list here all of the products that are promoted on your website for intended uses that cause them to be drugs. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.
We request that you take prompt action to correct all violations associated with your products, including the violations identified in this letter. Failure to do so may result in enforcement action without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products.
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. If you do not believe that your product is in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
Your written response should be sent to: U.S. Food and Drug Administration, 622 Main Street, Buffalo, New York 14202, Attn: Patricia A. Clark, Compliance Officer. If you have any questions about the contents of this letter, please contact Compliance Officer Patricia A. Clark by telephone at (716) 846-6236 or e-mail at firstname.lastname@example.org.