Raw Deal, Inc 11/21/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Jersey District Office
Waterview Corporate Center
10 Waterview Blvd. 3rd Floor
Parsippany, New Jersey 07054
Telephone: (973) 331- 4900
FAX: (973) 331-4969
November 21, 2013
VIA UPS OVERNIGHT
Mr. Barry I. Steinlight
President and Owner
Raw Deal, Inc.
99 Bartley Flanders Road
Flanders, New Jersey 07836
File No. 14-NWJ-01
Dear Mr. Steinlight:
From April 9 through May 6, 2013 the United States Food and Drug Administration (FDA)
inspected your dietary ingredient manufacturing facility located at 4 Gold Mine Road
, NJ 07836. During this inspection
, our investigators collected product labeling and manufacturing records. Our review of these documents has determined that your products are adulterated within the meaning of section 402(b)(2) [21 U.S.C
. §342(b)(2)] of the Food, Drug and
Cosmetic Act (the Act). You can find the Act and its implementing regulations on
's website www.fda.gov.
We acknowledge your written responses dated May 16, 21, 31, and September 25, 2013. The agency has reviewed your responses; however, these responses do not address the violations as noted below.
Your products, (b)(4) Pre-mix, (b)(4) Pre-mix, Allergy 1:1 Herb Blend, and Menopause Blend, are adulterated within the meaning of Section 402(b)(2) of the Act [21 U.S.C.§342(b)(2)], in that the ingredients used to manufacture the products have been substituted wholly or in part. Specifically, our review of your batch records, customer formulation specifications, product labels, and ingredient lists for the above listed blends, found that you used Maltodextrin and/or White Rice Powder as an ingredient in each of the blends; however, the formulation specifications provided to you by your customers do not include Maltodextrin and/or White Rice Powder. Furthermore, you created ingredient lists and provided them to your customers with each shipment of dietary ingredient blend, but you failed to list Maltodextrin in the ingredient list.
Likewise, the affidavit signed by Barry Steinlight, President and Owner, indicates that Maltodextrin was used in the manufacture of each of the above-mentioned blends, despite that the formulation specification provided by the customer does not include any Maltodextin, and that the ingredient lists provided to the customer do not list Maltodextrin. For example:
- On or about February 12, 2013 your customer ordered 100 kg (b)(4) Pre-mix. The (b)(4) Pre-mix formula provided by your customer lists the following ingredients: Ascorbic Acid, Alpha Lipoic Acid, and Citrus Bioflavonoids, and shows that these ingredients should comprise the total weight of the blend. However, when (b)(4) Pre-mix Batch #(b)(4)-20130225-00-2 was manufactured by your firm, the aforementioned ingredients only comprised 4.4% of the batch by weight, while 95.6% of the ingredients by weight were substituted with Maltodextrin and White Rice Powder. Maltodextrin and White Rice Powder were not listed on the finished product label or list of ingredients that your firm provided to your customer.
- On or about February 12, 2013 your customer ordered 15 kg (b)(4) Pre-mix. The (b)(4) Pre-mix formula provided by your customer lists the following ingredients: Vitamin B-12, Vitamin B-6, Folic Acid·, Magnesium Glycinate, Calcium D-Giucarate, Diindolymethan (DIM), Tumeric Extract-(b)(4), Milk Thistle Extract-(b)(4), and Broccoli Extract (b)(4) and shows that these ingredients should comprise the total weight of the blend. However, when (b)(4) Pre-mix Batch #EPM436-20130225-00-02 was manufactured by your firm, the aforementioned ingredients only comprised approximately 77% of the batch by weight, while approximately 23% of the ingredients by weight was substituted with Maltodextrin. Maltodextrin was not listed on your finished product label or list of ingredients that your firm provided to your customer.
- On or about August 9, 2012, your customer ordered 25 Kilograms of Allergy 1:1 Herb Blend. The Allergy 1:1 Herb Blend Raw Material Specification Document provided by your customer shows that the following ingredients should comprise 100% of the blend: Chrysanthemum Flower, Magnolia Flower, Angelica Dahurica Root, Chinese Chaste Tree Fruit, Atractylodes Rhizome, Codonopsis Root, Field Mint Leaf, Immature Tangerine Peel, Ledebouriella Root, Moutan Root Bark, Perilla Leaf, Schizonepeta Aerial Parts. However, when Allergy 1:1 Herb Blend, Batch #AHB-20120816-00-01 was manufactured by your firm, a portion of the ingredients in the blend was substituted with Maltodextrin; seven kilograms of Maltodextrin were added to the blend amounting to 28% of the blend by weight. Maltodextrin was not listed on the finished product label or the ingredient listing that your firm provided to your customer.
Furthermore, Dong Quai Powder was substituted for Angelica Dahurica Root, Orange Peel was substituted for Immature Tangerine Peel, and Epimedium PE 10% was substituted for Ledebouriella Root.
- On or about July 24, 2012, your customer ordered 25 kg of Menopause Blend. The Menopause Blend formula provided by your customer lists the following ingredients: Black Cohosh Powder, Don Quai Powder, Sage Powder, Borage GLA, Evening Primrose Powder, Soy lsoflavone Powder, and Vitex Berry Extract. The formula shows these ingredients should comprise 100% of the Menopause Blend; however, when Menopause Blend, Batch #MB-20120806-00-02, was manufactured, the aforementioned ingredients comprised 54% of the batch by weight, while 46% of the ingredients by weight were substituted with Maltodextrin. Maltodextrin was not declared on the Menopause Blend finished product label or on the ingredient listing that your firm provided to your customer.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. 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 assure 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 legal action without further notice, including, without limitation, seizure and injunction.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that 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 action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your response should be addressed to U.S. Food and Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey, 07054, Attn: Kerry Kurdilla, Compliance Officer.
New Jersey District