Inspections, Compliance, Enforcement, and Criminal Investigations
Bio-Botanica, Inc. 5/29/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty Avenue
Jamaica, NY 11433
May 29, 2013
WARNING LETTER NYK-DO 2013-20
RETURN RECEIPT REQUESTED
Attn: Mr. Frank D’Amelio, Sr.
75 Commerce Drive
Hauppauge, NY 11788
Dear Mr. D’Amelio:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website, www.naturesanswer.com, in April 2013 and has determined that your products “Hi-B Homocysteine,” “Goldenseal Root,” “Nature’s Answer® Bio-Flavonoids with Rosehip,” “Immune BoostTM,” “Gingko Leaf,” “Male Complex,” “Sambucus Nigra,” “Bio-Strath,” “Greens Today for Women,” and “Greens Today for Men,” are promoted for conditions that cause the products to be 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)]. The claims on your website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your products with these claims violates the Act.
On the webpage titled, “Cardiovascular Health”:
- “Clinical studies have shown a relationship between a high level of Homocysteine in the blood, and a variety of health problems including Heart Disease, Stroke, Crohn’s Disease, Alzheimer’s and Diabetes…. After carefully reviewing today’s most current research on cardiovascular health and its link with Homocysteine balancing, Nature’s Answer® has developed an exceptional vitamin/herbal blend formula called Hi-B Homocysteine. This nutrient-rich supplement features Vitamins B-6 and B-12, Folic Acid and Trimethylglycine (TMG), ingredients recognized for lowering Homocysteine levels.”
- “Red yeast rice (Monascus purpureus) [a “Key Ingredient” in your Hi-B Homocysteine product] also contains compounds which may inhibit the synthesis of cholesterol in the liver.… Since elevated Homocysteine has been shown to be indicative of cardiovascular disease, it is prudent to support the body in lowering cholesterol levels in conjunction with lowering Homocysteine.”
On the page titled, “Colds & Flu”:
- “Another ideal herb for immune support is featured in Nature’s Answer®’s Goldenseal (alcohol-free) formula. Goldenseal contains the active ingredient Berberine, which has been shown to have antibacterial properties.”
- “Nature’s Answer® Bio-Flavonoids with Rosehip … provides the body with the extra nutrients it needs to ward off colds and flu.”
On the page titled, “Immune Health”:
- “Osha Root has been used … for colds and flues [sic]…. Thuja is an herbal extract … used for colds, … bronchitis and other respiratory infections.… Nature’s Answer® combines these herbs in Immune BoostTM, a combination formula for use during acute illness and infections.”
On the page titled, “Memory”:
- “Gingko Biloba made medical history when the Journal of the American Medical Association published research about its usefulness for senile dementia…. Other applications for this herb include impotence, macular degeneration, tinnitus … and asthma.… Nature’s Answer® offers Ginkgo Biloba as a liquid extract (alcohol-free, organic alcohol).”
On the page titled, “Men’s Health”:
- “Muira Puama, also known as … ‘Potency Wood’, … is listed in the British Herbal Pharmacopoeia, [where it is] recommended as a treatment for impotence. Studies in France have verified the herb’s usefulness for men for … reducing impotence. Nature’s Answer Male Complex (vegetarian Capsule) combines several of these herbs into one formula….”
In addition, your website contains disease claims in the form of testimonials, for example:
On the page titled, “Nature’s Answer Customer Testimonials”:
- “My brother and I know that the Sambucus Nigra is doing wonders for him. My brother is a cancer patient … and feels now much better and stronger as a result of this product since he started using it just a few weeks ago, and his cardiologist told him last week on Monday that his heart seems much stronger, too! I started buying the elixir for him after I tested it on myself when I was ill before that and was already on a second prescription of antibiotics and still was not getting any better. After only 3 days of taking the elixir it started working for me and I finally recuperated from my lung infection….”
- “I am a 31 year old mother of a 4 year old daughter…. After hearing you speak so passionately about Bio-Strath and its amazing properties, I put my 4 year old daughter onto it and the results were amazing. She started going to creche in January this year and used to come home with a sore thoat [sic], runny nose etc. She would also very often get head colds and influenza, so I started giving her the Bio-Strath bare Necessities for [sic]syrup for toddlers and I was pleasantly surprised at the change in just a few weeks. She very seldom gets tonsillitis now, whereas previously she used to get it every few weeks. If she does get ill, she doesn’t get knocked off her feet as in the past. She recovers much faster now.”
- “My son … was diagnosed last year, 2007, with ADHD and immediatly [sic] put on Ritalin. The Ritalin seemed to work but when the doctors … put him on a stronger dosage his whole personality changed.… We many times saw the advertisement for Bio-Strath on the television and many people who also have children ith [sic] ADHD explained the amazing changes to their children once they had started with Bio-Strath.… [W]e then bought a packet of sixty Bio-Strath Tablets…. The change was amazing!! Within a week we could see the difference and even the teacher at his school noticed it.... [H]is ADHD is under control. I would encourage anyone to take this product as it comes close to being a miracle in tablet form. Anyone who is on Ritalin should try Bio-Strath first before carrying on with Ritalin.”
- “The doctors had found a lump in my mother’s breast and she was told to possibly go under chemotherapy. She refused and was introduced to Greens Today for Women. She went back after taking it for a month and the doctors said that there was nothing there no more. She lost body fat and all of her vital organs were working great. Even they were amazed and were asking her what she was taking.”
- “I am a middle school physical education teacher…. I am exposed to so many germs everyday but since I have been taking the Greens Today for Men, and the Original Formula daily I haven’t been sick or caught the flu the whole year.”
- “[I’]m a 36 yr old male and 3 months [ago] i was diagnosed with cancer, well i thought it was going to be a death sentence but my sister … came over to see me and brought me 3 tubs of Green’s Today Mens blend, can i tell you that even through my chemo i’ve never felt so well in my entire life, my chemo is working really really well and my oncologist is amazed at how well i’m doing and has asked what ive been doing , my cancer cell count is going down and down and my good blood cells are going up and up, my skin is glowing i’m full of energy and my god, i can’t beleive [sic] it, i just had to let you know as well your company and the people that formulated the blend have literally saved my life and have given me the fight to stay alive, so just to let you know that i think you have saved a life, and my my [sic] life easier to have the confidence to carry on with my treatment…[.]”
In addition, when scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product’s intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a dietary supplement is considered to be a claim about disease treatment or prevention if the citation refers to a disease use and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease. The following are examples of publications that are used to market your product Hi-B Homocysteine for disease treatment and prevention on your website and are thus evidence of your product’s intended use as a drug:
- Clarke R, Smith D, Jobst KA, et al. Folate, vitamin B12, and serum total homocysteine levels in confirmed Alzheimer disease. Arch Neruol [sic] 1998; 55:1449-55.
- Pietrzik, K. Rationale for risk reduction of cardiovascular disease using homocysteine concentration in blood and plasma as biomarker: support by clinical data., Bibl Nutr Dieta, 55, 2001, 34-41.
Your products “Hi-B Homocysteine,” “Goldenseal Root,” “Nature’s Answer® Bio-Flavonoids with Rosehip,” “Immune BoostTM,” “Gingko Leaf,” “Male Complex,” “Sambucus Nigra,” “Bio-Strath,” “Greens Today for Women,” and “Greens Today for Men”are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Furthermore, your products “Hi-B Homocysteine,” “Ginkgo Leaf,” “Male Complex,” “Sambucus Nigra,” “Bio-Strath,” “Greens Today for Women,” and “Greens Today for Men” are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
The violations cited in this letter are not meant to be an all-inclusive list of violations that exist in connection with your products and their labeling. 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 your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing as to the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the time within which you will complete the corrections.
Please send your reply to the attention of Lillian C. Aveta, Compliance Officer, Food and Drug Administration, 158-15 Liberty Ave., Jamaica, NY 11433. If you have any questions regarding this letter, please contact Ms. Aveta at 718-662-5576.
Ronald M. Pace
New York District
cc: Michael Tagner
85 Commerce Drive
Hauppauge, NY 11788