Inspections, Compliance, Enforcement, and Criminal Investigations

Napa Valley Bioscience 5/18/18

 

  

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WARNING LETTER

MAY 18 2018


VIA EXPRESS DELIVERY

David Murphy, President
Napa Valley Bioscience
2118 Wilshire Blvd.
Suite 155
Santa Monica CA 90403

Re: 548342

This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.sunsaferx.com in March 2018 and has determined that you take orders there for the product Sunsafe Rx. In addition, FDA reviewed your product label and labeling after purchasing your product from your website. The claims on your website, product label, and product labeling establish that the 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 diagnosis, 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 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 Sunsafe Rx product is intended for use as a drug include:

On your homepage:

• “Sunsafe Rx is a nutritional supplement that protects your skin and eyes from the sun. Just one capsule per day provides natural, healthy…protection from UV rays.”
• "BROAD SPECTRUM PROTECTION Protects you from UVA and UVB rays…"
• "RELIEF FOR PHOTOSENSITIVITIES Can help prevent or treat…solar keratosis…”
• “Every second you spend in the sun damages your skin. But Sunsafe Rx is always working: it protects your whole body ….”
• “The secret to Sunsafe Rx is Antioxidine. … can defend your skin and eyes from sun damage.”

On your Reviews page:

• “I don’t burn as I used to, as I would notice sunburn after only being in the sun for 15 or 20 minutes before using the product....”
• “I can surf without having to keep reapplying sunblock as frequently.”
• “[E]ven taking it a couple of hours before mid-day sun exposure (near the Equator!), my non-suntanned body did not burn.”

On your How It Works page:

•  “Sunsafe Rx uses specific ingredients, … which … can promote your skin’s natural defenses against UV rays. These powerful antioxidants help your body quench free radicals created by ultraviolet radiation before they can do extensive damage.”

On your Benefits page:

• “[P]rotect you from both UVA and UVB rays.”
• “[L]utein and zeaxanthin protect your eyes from the oxidative stress of UV rays and may help fight the causes of age-related macular degeneration."

On your Resources: Photosensitivity page:

• “Photosensitivity refers to a number of skin conditions caused or aggravated by sunlight. In people who are photosensitive, sun exposure may result in a reaction including redness, rashes, or blisters. Sunsafe Rx is made with ingredients that have been shown to help prevent or treat some of these reactions. In particular, research shows that the ingredients in Sunsafe Rx may be able to provide some relief for people with: Erythema…Polymorphous light eruption (polymorphic light eruption), Actinic keratosis (solar keratosis), Solar urticaria, … Sensitivity caused by medications …”
• “People undergoing UV treatments for various skin conditions may also find Sunsafe Rx valuable. These include: Vitiligo, Psoriasis, Eczema” 

On your Resources: Sunscreen page:

• “Sunsafe Rx defends against the damaging effects of both UVA and UVB rays without any of the dangerous health concerns of sunscreen lotion use.”

On your Health and Wellness page:

• “One compound in particular that, when taken orally, can help prevent sunburn (also present in Sunsafe Rx: SunsafeRx.com)”
• “Another alternative to sunscreen lotions are oral supplements proven to protect skin from sun damage, such as Sunsafe Rx.”

On your FAQ page:

• “The antioxidants in Sunsafe Rx help prevent skin damage from both UVA and UVB rays by neutralizing the free radicals created by ultraviolet radiation (mitigating the resulting damage that otherwise would have occurred)”
• “In addition to defending against the damaging effects of ultraviolet rays …the antioxidants in Sunsafe Rx also … exhibit photo-protection for eyes. These ingredients may also help prevent or relieve …photosensitivities and photodermatoses.”
• “How long can I be in the sun without getting burned while using Sunsafe Rx?... The ingredients in Sunsafe Rx can help your body naturally defend itself against ultraviolet radiation ….”
• “[T]he damage being caused by UVA rays cannot be detected …. Sunsafe Rx can help mitigate this damage.”
• “Sunsafe Rx overcomes many of the limitations of topical sunscreens: Sunsafe Rx provides protection against both UVA and UVB rays …”

Examples of some of the product label claims that provide evidence that your Sunsafe Rx product is intended for use as a drug include:

• “Sunsafe Rx … promote your skin’s defenses against the damaging effects of both UVA and UVB rays.”
• “Help skin naturally defend against sun damage”

Examples of some of the product labeling, including brochure and letter, claims that provide evidence that your Sunsafe Rx product is intended for use as a drug include:

• “[I]ncreases your skin’s ability to protect itself from sun damage.”
• “By using Sunsafe Rx, you are naturally helping your skin defend against harmful ultraviolet radiation from the sun ….”
• “[S]cientifically proven to protect your skin from UVA and UVB rays ….”
•  “Defend against both UVA and UVB rays”
• “Reduce skin inflammation”
• “[P]rotection against harmful UV rays.”
• “UVA and UVB-protective properties.”
• “[U]sed orally for photo-protection…. All the other ingredients in Antioxidine also have similar photo-protective properties ….”
• “[P]rotect sensitive eye tissue from damaging UV radiation.”
• “Antioxidine … ingredients are able to promote your skin’s natural defenses against the harmful effects of the sun ….”

Your Sunsafe Rx 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. 

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 CFR 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 Sunsafe Rx product is intended for treatment and/or prevention of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner, including actinic keratosis, photodermatoses, photosensitivities, and macular degeneration.  Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes.  Accordingly, the Sunsafe Rx product fails to bear adequate directions for its intended use 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)].

This letter is not an all-inclusive statement of violations associated with your product or its 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.

If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. 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 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.

You should direct your written reply to Beth Tirio, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions regarding this letter, you may contact Ms. Tirio via email at beth.tirio@fda.hhs.gov.          


Sincerely,
/s/     
William Correll
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
US Food and Drug Administration

     
Cc: ORA/OHAFO 5W

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