Inspections, Compliance, Enforcement, and Criminal Investigations

Karen Roche 7/15/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500
Fax 781.587.7556
 
 
WARNING LETTER
CMS # 497343
 
VIA UNITED PARCEL SERVICE
 
 
July 15, 2016
 
Karen Roche, Founder
Be Green Bath and Body
9 Robin Lane
North Easton, MA 02356
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://begreenbathandbody.com/ in May 2016 and has determined that you take orders there for the products Rose Hip Scar Oil Treatment, Evening Primrose Healing Oil, Organic Shea Butter Tin, and Calendula Cream. The claims on your website establish that the products are drugs 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 they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products 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 products are intended for use as drugs include:
 
Rose Hip Scar Oil Treatment
  • “[H]eal damaged skin from scars and burns.”
  • “[R]educe scar tissue and stimulate the growth of new skin tissue.”
  • “Scar Oil Treatment is beneficial for many skin conditions such as rosacea, dermatitis, eczema, acne and psoriasis.”
Evening Primrose Healing Oil 
  • “Natural relief for eczema flare-ups”
  • “High in essential fatty acids and rare gamma linolenic oil this oil is …very beneficial as an eczema treatment.”
Organic Shea Butter Tin
  • “[B]eneficial for many skin conditions, including … cracked skin, sun burn, chapped lips… psoriasis and eczema.”
Calendula Cream
  • “[F]or customers suffering from eczema flare-ups.”
  • “Made with organic oils…calendula that has calming, anti-inflammatory and healing properties.”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” 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 Rose Hip Scar Oil Treatment product 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 its intended purposes. Accordingly, your Rose Hip Scar Oil Treatment 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 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.
 
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 the Food and Drug Administration, One Montvale Ave. Stoneham, MA. 02180 (Attn: CAPT Diane M Prince).  If you have any questions about the contents of this letter, please contact Diane Prince at 781-587-7442.
 
                                                                                   
Sincerely,
/S/                                                           
Joseph S. Matrisciano
District Director
New England District Office

Page Last Updated: 07/21/2016
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