Total Nutrition Latest Own-Label Supplement Marketer Warned On GMP Violations

FDA warns Total Nutrition that it violated numerous supplement GMPs and reminds the firm that own-label marketers are ultimately responsible for ensuring their contract manufacturers’ compliance. The agency also said numerous online claims rendered the products as unapproved drugs.

FDA reminds dietary supplement marketer and distributor Total Nutrition Inc. in a warning letter that a product’s marketer has ultimate responsibility for good manufacturing practices, labeling and other regulatory compliance.

“Although your firm may contract out certain dietary supplement manufacturing operations, it cannot by the same token, contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce is not adulterated for failure to comply with” supplement GMP requirement,” FDA stated in an Aug. 16 warning letter.

An inspection of the firm’s Farmingdale, N.Y., facility in March and April found GMP violations related to numerous products the company makes or distributes under the Total Nutrition brand, including Aller Ease, Airway Clear, Inflam Ease, Osteo-Gest, Arth-Support, Green Energy Tablets, Olive Leaf Extract, Astragalus Root, Elderberry Sambucus, Tart Cherry, Turmeric Curcumin and Naptro-Zyn with Turmeric, Bromelain and Boswellia.

Among the violations, FDA noted Total Nutrition failed to establish and follow written procedures for quality control operations’ responsibilities, including procedures for conducting a material review of products and making a disposition decision, and for approving or rejecting any reprocessing as required by supplement GMP final rule of 2007.

In its May 1 response to FDA’s form 483 findings, Total Nutrition said it would not receive finished bulk from its contract manufacturers for holding, packaging and distribution unless the batch was accompanied with proper certificate of analysis and contaminant testing.

However, FDA said previous CoAs from the firm’s contract manufacturer for bulk shipments of Green Energy tablets, Arth-Support capsules and Inflam Ease capsules indicate strength of product “based on input” at the contract manufacturer or at the time of manufacturing, and does not reflect required analytical testing of finished product.

“Such certificates of analyses would not provide an appropriate basis upon which your quality control operations could approve the dietary supplement for distribution because such CoAs do not verify, using appropriate tests or examinations, that the dietary supplement meets product specifications,” FDA said.

Once those procedures are established, the firm can implement quality control operations into packaging, labeling and holding operations before quality control personal review and approve the release of any packaged and labeled supplements for distribution, FDA added.

“As a distributor that contracts with other manufacturers to manufacture, package or label dietary supplements that your firm releases for distribution … your firm has an obligation to know what and how manufacturing activities are performed so that you and make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution,” FDA added.

Other GMP violations included failure to:

• include complete information relating to production and control of each batch, including time of maintenance, cleaning and sanitizing of equipment and processing lines used in producing the batch, the quantity of the packaging and labels used for products;
• establish and follow written procedures to fulfill requirements related to returned products;
• designate a qualified person to review and investigate all product companies.

The agency frequently has advised own-label marketers and distributors that receive finished products that they ultimately are responsible for contract manufacturers’ GMP compliance since beginning inspections in 2010 under the supplement GMP final rule. (Also see "GMP Warnings Follow Thin Corrective Action Evidence, Reliance On Contract Manufacturers" - HBW Insight, 31 May, 2017.)

In April, the Council for Responsible Nutrition said that a recall of liquid supplements from contract manufacturer PharmaTech LLC due to antibiotic-resistant pathogen contamination is a reminder to supplement marketers that tracking supply chains and auditing contract manufacturers is critical to avoid problems in manufacturing. (Also see "PharmaTech Recalls Highlight Supplement GMP Diligence For Marketers – CRN" - HBW Insight, 16 Aug, 2017.)

PharmaTech’s problems became apparent in 2016 when the Centers for Disease Control and Prevention detected bacteria burkholderia cepacia in an Rx laxative the firm manufactured, which led to a recall of a large number of supplements the firm had manufactured for brand marketers, including Ruby Laboratories Inc. The pathogen was traced to water used in the manufacturing process.

Unapproved & Misbranded New Drugs

In reviewing Total Nutrition’s websites, FDA found numerous claims that provide evidence the company’s products are intended for use as drugs. These include that Aller Ease is a natural antihistamine and that Inflam Ease can promote healing “from minor sprains and injury” (see chart below).

The brand’s categorization of products also suggests they are drugs. Tart Cherry, Turmeric Curcumin and Napro-Zyn products are grouped under “inflammation & pain relief”; Olive Leaf Extract, Astragalus Root and Elderberry Sambucus products under “cold & flu” and Aller Ease and Airway Clear under “asthma clear.”

As the products identified are drugs by their claims, they also are misbranded because they do not contain adequate directions for use, FDA said. Further, Aller Ease and Airway Clear are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the oversight of a licensed practitioner, the agency added.

Other labeling problems included:

• Osteo-Gest and Inflam Ease labels do not bear a current domestic address or phone number for reporting adverse events to the firm;
• Green Energy labels do not identify the part of the plant from which the botanical dietary ingredient is derived;
• Arth Support labels feature incorrect serving size;

Drug Claims Noted In Warning Letter

Product	Violative Claim
Aller Ease	“Antihistamines” “Quercetin: Natural antihistamine” “Bromelain: Natural anti-inflammatory for sinus relief.” “Nettle Root: Herb traditionally used for treatment of hay fever & other allergies.” “Nature’s Allergy Relief Formula.”
Inflam Ease	“Provides the most effective natural ingredients to promote healing from minor sprains and injury.” “Potent relief of pain from inflammation.” “Natural anti-inflammatory” “Inflam Ease works synergistically to natural relieve pain & swelling due to inflammation.”
Airway Clear	“Herbal combination provides quick temporary relief of shortness of breath, tightness of chest and wheezing due to bronchial asthma.”
Osteo-Gest	“State-of-the-art, bone-building osteoporosis support formula.”
Arth-Support	“Contains ingredients that are key structural components in cartilage and play important roles in the maintenance of joint cartilage where arthritis may be found.”